FIFO method in inventory – SOP Guide for Pharma https://www.pharmasop.in The Ultimate Resource for Pharmaceutical SOPs and Best Practices Mon, 19 May 2025 07:06:00 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 SOP for Documentation of Raw Material Issuance in ERP System – V 2.0 https://www.pharmasop.in/sop-for-documentation-of-raw-material-issuance-in-erp-system-v-2-0/ Mon, 19 May 2025 07:06:00 +0000 https://www.pharmasop.in/?p=8604 Read More “SOP for Documentation of Raw Material Issuance in ERP System – V 2.0” »

]]> SOP for Documentation of Raw Material Issuance in ERP System – V 2.0

Standard Operating Procedure for Documentation of Raw Material Issuance in ERP System

Department Warehouse / Production / Quality Assurance
SOP No. SOP/RM/200/2025
Supersedes SOP/RM/200/2022
Page No. Page 1 of 15
Issue Date 05/05/2025
Effective Date 12/05/2025
Review Date 05/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for documenting raw material issuance in the Enterprise Resource Planning (ERP) system to ensure traceability, accuracy, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the documentation, verification, and issuance of raw materials using the ERP system in pharmaceutical manufacturing.

3. Responsibilities

  • Warehouse Staff: Accurately document raw material issuance in the ERP system.
  • Production Supervisor: Verify ERP entries before material usage in manufacturing.
  • Quality Assurance (QA) Team: Oversee ERP documentation compliance and conduct audits.

4. Accountability

The Warehouse Manager is accountable for the correct documentation of raw material issuance in the ERP system. The Production Supervisor ensures the accuracy of ERP records before usage, while the QA Manager ensures compliance through regular audits.

5. Procedure

5.1 Preparation for ERP Documentation

  1. Review of Batch Manufacturing Record (BMR):
    • Review the BMR to identify the required raw materials and quantities for issuance.
    • Record the review in the BMR Review Log (Annexure-1).
  2. ERP System Access:
    • Ensure authorized personnel have access to the ERP system for documentation.
    • Document system access in the ERP Access Log (Annexure-2).

5.2 Documentation Process in ERP

  1. Entering Raw Material Details:
    • Log into the ERP system and navigate to the raw material issuance module.
    • Enter details such as material name, batch number, quantity, and date of issuance.
    • Document the entries in the ERP Entry Log (Annexure-3).
  2. Verification of ERP Entries:
    • Cross-check ERP entries against the BMR to ensure accuracy.
    • Document verification in the ERP Verification Log (Annexure-4).

5.3 Handling Discrepancies in ERP Documentation

  1. Identification of Discrepancies:
    • Report any discrepancies in ERP entries immediately to QA for review.
    • Document discrepancies in the ERP Discrepancy Log (Annexure-5).
  2. Corrective Actions:
    • Implement corrective actions for discrepancies as recommended by QA.
    • Document corrective actions in the ERP Corrective Action Log (Annexure-6).

5.4 Approval and Finalization

  1. Final Approval of ERP Entries:
    • Ensure all ERP entries are reviewed and approved by the Warehouse Manager and QA.
    • Document final approval in the ERP Approval Log (Annexure-7).
  2. Finalization of Issuance:
    • Confirm the issuance of materials based on verified ERP entries before transferring to production.
    • Document the final issuance in the Final Issuance Log (Annexure-8).

5.5 Training and Compliance Monitoring

  1. Training on ERP Documentation:
    • Conduct regular training sessions for warehouse and production staff on ERP documentation procedures.
    • Document training sessions in the ERP Training Log (Annexure-9).
  2. Compliance Audits:
    • QA personnel conduct periodic audits to ensure ERP documentation compliance.
    • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • ERP: Enterprise Resource Planning
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practices

7. Documents

  1. BMR Review Log (Annexure-1)
  2. ERP Access Log (Annexure-2)
  3. ERP Entry Log (Annexure-3)
  4. ERP Verification Log (Annexure-4)
  5. ERP Discrepancy Log (Annexure-5)
  6. ERP Corrective Action Log (Annexure-6)
  7. ERP Approval Log (Annexure-7)
  8. Final Issuance Log (Annexure-8)
  9. ERP Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on GMP for Pharmaceutical Products
  • FDA Guidance on ERP System Management in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Review Log

Date BMR Number Reviewed By Remarks
05/05/2025 BMR-23456 Ravi Kumar Reviewed and Approved

Annexure-2: ERP Access Log

Date User ID Access Level Authorized By
05/05/2025 USR001 Full Access Neha Verma

Annexure-3: ERP Entry Log

Date Material Name Batch Number Quantity (kg) Entered By
05/05/2025 Paracetamol API BN-78901 20 kg Kiran Patel

Annexure-4: ERP Verification Log

Date Material Name Batch Number Verified By
05/05/2025 Paracetamol API BN-78901 Amit Joshi

Annexure-5: ERP Discrepancy Log

Date Discrepancy Identified Description Reported By
05/05/2025 Incorrect Batch Entry Batch number mismatch in ERP system QA Team

Annexure-6: ERP Corrective Action Log

Date Issue Corrective Action Taken Performed By
05/05/2025 Incorrect Batch Entry Corrected the ERP entry Warehouse Staff

Annexure-7: ERP Approval Log

Date Material Name Batch Number Approved By
05/05/2025 Paracetamol API BN-78901 QA Head

Annexure-8: Final Issuance Log

Date Material Name Batch Number Issued To
05/05/2025 Paracetamol API BN-78901 Production Department

Annexure-9: ERP Training Log

Date Employee Name Training Topic Trainer Remarks
05/05/2025 Neha Verma ERP Documentation Procedures QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
05/05/2025 2.0 Included detailed ERP documentation and discrepancy handling procedures. Regulatory Update QA Head
]]> SOP for Cross-Checking Weighed Materials Before Issuance – V 2.0 https://www.pharmasop.in/sop-for-cross-checking-weighed-materials-before-issuance-v-2-0/ Sun, 18 May 2025 15:16:00 +0000 https://www.pharmasop.in/?p=8603 Read More “SOP for Cross-Checking Weighed Materials Before Issuance – V 2.0” »

]]> SOP for Cross-Checking Weighed Materials Before Issuance – V 2.0

Standard Operating Procedure for Cross-Checking Weighed Materials Before Issuance

Department Warehouse / Production / Quality Assurance
SOP No. SOP/RM/199/2025
Supersedes SOP/RM/199/2022
Page No. Page 1 of 15
Issue Date 04/05/2025
Effective Date 11/05/2025
Review Date 04/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for cross-checking weighed raw materials before issuance to ensure accuracy, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the weighing, verification, and issuance of raw materials for pharmaceutical manufacturing.

3. Responsibilities

  • Warehouse Staff: Weigh raw materials accurately and ensure proper documentation.
  • Production Supervisor: Cross-check and verify the weighed materials before usage in production.
  • Quality Assurance (QA) Team: Oversee compliance with weighing protocols and conduct periodic audits.

4. Accountability

The Warehouse Manager is accountable for ensuring accurate weighing and cross-checking of materials before issuance. The Production Supervisor is responsible for verifying the correctness of materials used in manufacturing, while the QA Manager ensures compliance through audits.

5. Procedure

5.1 Preparation for Material Weighing

  1. Review of Batch Manufacturing Record (BMR):
    • The Warehouse Supervisor reviews the BMR to identify the required materials and quantities.
    • Document the review in the BMR Review Log (Annexure-1).
  2. Calibration of Weighing Equipment:
    • Ensure that all weighing equipment is calibrated before use.
    • Record calibration details in the Equipment Calibration Log (Annexure-2).

5.2 Material Weighing Process

  1. Weighing of Materials:
    • Weigh the materials according to the specified quantity in the BMR using calibrated equipment.
    • Document the weighed quantities in the Material Weighing Log (Annexure-3).
  2. Labeling of Weighed Materials:
    • Label each weighed container with the material name, batch number, and weight.
    • Record labeling details in the Material Labeling Log (Annexure-4).

5.3 Cross-Checking of Weighed Materials

  1. Verification of Weighed Materials:
    • The Production Supervisor or QA personnel cross-check the weighed materials against the BMR for accuracy.
    • Document the verification in the Material Verification Log (Annexure-5).
  2. Documentation of Discrepancies:
    • Any discrepancies between the weighed materials and the BMR should be reported to QA immediately.
    • Document discrepancies in the Discrepancy Log (Annexure-6).

5.4 Issuance of Verified Materials

  1. Approval for Issuance:
    • Only materials that have been cross-checked and verified should be issued to the production department.
    • Document the issuance in the Material Issuance Log (Annexure-7).
  2. Handling of Non-Compliant Materials:
    • Non-compliant materials should be quarantined and corrective actions should be initiated.
    • Document corrective actions in the Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

  1. Training on Weighing and Cross-Checking Procedures:
    • Conduct regular training sessions for warehouse and production staff on weighing and cross-checking procedures.
    • Document training sessions in the Training Log (Annexure-9).
  2. Compliance Audits:
    • QA personnel conduct periodic audits to ensure compliance with weighing and cross-checking procedures.
    • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practices

7. Documents

  1. BMR Review Log (Annexure-1)
  2. Equipment Calibration Log (Annexure-2)
  3. Material Weighing Log (Annexure-3)
  4. Material Labeling Log (Annexure-4)
  5. Material Verification Log (Annexure-5)
  6. Discrepancy Log (Annexure-6)
  7. Material Issuance Log (Annexure-7)
  8. Corrective Action Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on GMP for Pharmaceutical Products
  • FDA Guidance on Weighing and Verification Procedures

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Review Log

Date BMR Number Reviewed By Remarks
04/05/2025 BMR-12345 Ravi Kumar Reviewed and Approved

Annexure-2: Equipment Calibration Log

Date Equipment ID Calibration Status Calibrated By
04/05/2025 WEIGH-001 Calibrated Neha Verma

Annexure-3: Material Weighing Log

Date Material Name Batch Number Weighed Quantity (kg) Weighed By
04/05/2025 Ibuprofen API BN-67890 25 kg Kiran Patel

Annexure-4: Material Labeling Log

Date Material Name Label Information Labeled By
04/05/2025 Ibuprofen API Batch BN-67890, 25 kg Amit Joshi

Annexure-5: Material Verification Log

Date Material Name Batch Number Verified By
04/05/2025 Ibuprofen API BN-67890 QA Team

Annexure-6: Discrepancy Log

Date Discrepancy Identified Description Reported By
04/05/2025 Weight Mismatch Weighed quantity did not match BMR QA Team

Annexure-7: Material Issuance Log

Date Material Name Batch Number Issued To
04/05/2025 Ibuprofen API BN-67890 Production Department

Annexure-8: Corrective Action Log

Date Issue Corrective Action Taken Performed By
04/05/2025 Weight Mismatch Reweighed and corrected the quantity Warehouse Staff

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
04/05/2025 Neha Verma Weighing and Cross-Checking Procedures QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
04/05/2025 2.0 Added procedures for cross-checking weighed materials. Regulatory Update QA Head
]]> SOP for Issuing APIs to Manufacturing Based on Approved List – V 2.0 https://www.pharmasop.in/sop-for-issuing-apis-to-manufacturing-based-on-approved-list-v-2-0/ Sat, 17 May 2025 23:26:00 +0000 https://www.pharmasop.in/?p=8602 Read More “SOP for Issuing APIs to Manufacturing Based on Approved List – V 2.0” »

]]> SOP for Issuing APIs to Manufacturing Based on Approved List – V 2.0

Standard Operating Procedure for Issuing APIs to Manufacturing Based on Approved List

Department Warehouse / Production / Quality Assurance
SOP No. SOP/RM/198/2025
Supersedes SOP/RM/198/2022
Page No. Page 1 of 15
Issue Date 03/05/2025
Effective Date 10/05/2025
Review Date 03/05/2026

1. Purpose

This Standard Operating Procedure (SOP) defines the process for issuing Active Pharmaceutical Ingredients (APIs) to the manufacturing department based on an approved list to ensure compliance with regulatory guidelines and Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the issuance, verification, and documentation of APIs in the pharmaceutical manufacturing process.

3. Responsibilities

  • Warehouse Staff: Issue APIs according to the approved list and ensure accurate documentation.
  • Production Supervisor: Verify that only approved APIs are used in manufacturing.
  • Quality Assurance (QA) Team: Oversee compliance with issuance protocols and conduct periodic audits.

4. Accountability

The Warehouse Manager is accountable for ensuring the correct issuance of APIs based on the approved list. The Production Supervisor ensures that only approved APIs are used in manufacturing, while the QA Manager verifies compliance through audits.

5. Procedure

5.1 Receipt and Review of Approved API List

  1. Submission of Approved API List:
    • The Production Department submits an approved API list to the Warehouse for issuance.
    • Document the receipt in the Approved API List Receipt Log (Annexure-1).
  2. Review of Approved API List:
    • The Warehouse Supervisor reviews the approved API list for completeness and authorization.
    • Document the review in the Approved API List Review Log (Annexure-2).

5.2 API Issuance Process

  1. Selection of APIs:
    • Select APIs from the warehouse inventory based on the approved list, following FIFO (First-In, First-Out) or FEFO (First-Expiry, First-Out) principles.
    • Record selection details in the API Selection Log (Annexure-3).
  2. Weighing of APIs:
    • Weigh APIs according to the specified quantity in the approved list using calibrated equipment.
    • Document weighing details in the API Weighing Log (Annexure-4).

5.3 Verification and Documentation

  1. Cross-Verification of APIs:
    • The Production Supervisor or QA personnel verifies the selected APIs against the approved list for correct batch numbers and quantities.
    • Log verification details in the API Verification Log (Annexure-5).
  2. Labeling of Issued APIs:
    • Label the issued APIs with the batch number, API name, and weight as per the approved list.
    • Document labeling in the API Labeling Log (Annexure-6).

5.4 Handling Discrepancies

  1. Identification of Discrepancies:
    • Report any discrepancies between the issued APIs and the approved list to QA immediately.
    • Document discrepancies in the API Discrepancy Log (Annexure-7).
  2. Corrective Actions:
    • Implement corrective actions for discrepancies and document resolutions in the API Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

  1. Training on API Issuance Procedures:
    • Conduct regular training sessions for warehouse and production staff on API issuance procedures.
    • Document training sessions in the API Training Log (Annexure-9).
  2. Compliance Audits:
    • QA personnel conduct periodic audits to ensure compliance with API issuance procedures.
    • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • FIFO: First-In, First-Out
  • FEFO: First-Expiry, First-Out

7. Documents

  1. Approved API List Receipt Log (Annexure-1)
  2. Approved API List Review Log (Annexure-2)
  3. API Selection Log (Annexure-3)
  4. API Weighing Log (Annexure-4)
  5. API Verification Log (Annexure-5)
  6. API Labeling Log (Annexure-6)
  7. API Discrepancy Log (Annexure-7)
  8. API Corrective Action Log (Annexure-8)
  9. API Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on GMP for Pharmaceutical Products
  • FDA Guidance on API Handling and Issuance Procedures

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Approved API List Receipt Log

Date API List Number Received By Production Batch Number
03/05/2025 API-56789 Ravi Kumar PB-00321

Annexure-2: Approved API List Review Log

Date API List Number Reviewed By Remarks
03/05/2025 API-56789 Neha Verma Complete and Approved

Annexure-3: API Selection Log

Date API Name Batch Number Selected By
03/05/2025 Paracetamol API BN-65432 Amit Joshi

Annexure-4: API Weighing Log

Date API Name Weighed Quantity (kg) Weighed By
03/05/2025 Paracetamol API 20 kg Kiran Patel

Annexure-5: API Verification Log

Date API Name Batch Number Verified By
03/05/2025 Paracetamol API BN-65432 QA Team

Annexure-6: API Labeling Log

Date API Name Label Information Labeled By
03/05/2025 Paracetamol API Batch BN-65432, 20 kg Ravi Kumar

Annexure-7: API Discrepancy Log

Date Discrepancy Identified Description Reported By
03/05/2025 Incorrect API Batch Number Mismatch between approved list and issued batch QA Team

Annexure-8: API Corrective Action Log

Date Issue Corrective Action Taken Performed By
03/05/2025 Incorrect API Issuance Re-issued correct batch Warehouse Staff

Annexure-9: API Training Log

Date Employee Name Training Topic Trainer Remarks
03/05/2025 Neha Verma API Issuance Procedures QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
03/05/2025 2.0 Included detailed discrepancy handling procedures. Regulatory Update QA Head
]]> SOP for Verification of Raw Material Batch Number Before Issuance – V 2.0 https://www.pharmasop.in/sop-for-verification-of-raw-material-batch-number-before-issuance-v-2-0/ Sat, 17 May 2025 07:36:00 +0000 https://www.pharmasop.in/?p=8601 Read More “SOP for Verification of Raw Material Batch Number Before Issuance – V 2.0” »

]]> SOP for Verification of Raw Material Batch Number Before Issuance – V 2.0

Standard Operating Procedure for Verification of Raw Material Batch Number Before Issuance

Department Warehouse / Production / Quality Assurance
SOP No. SOP/RM/197/2025
Supersedes SOP/RM/197/2022
Page No. Page 1 of 15
Issue Date 02/05/2025
Effective Date 09/05/2025
Review Date 02/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for verifying raw material batch numbers before issuance to ensure accurate material identification, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the verification, issuance, and documentation of raw materials in the pharmaceutical manufacturing process.

3. Responsibilities

  • Warehouse Staff: Verify batch numbers before issuing materials and document the verification process.
  • Production Supervisor: Ensure that only verified materials with correct batch numbers are used in production.
  • Quality Assurance (QA) Team: Oversee and audit the verification process for compliance with GMP.

4. Accountability

The Warehouse Manager is accountable for ensuring the correct verification of batch numbers before issuance. The Production Supervisor ensures compliance during material usage, while the QA Manager conducts audits to verify adherence to the SOP.

5. Procedure

5.1 Preparation for Batch Verification

  1. Review of Batch Manufacturing Record (BMR):
    • Ensure that the Batch Manufacturing Record (BMR) specifies the required batch numbers for raw materials.
    • Document the BMR review in the BMR Review Log (Annexure-1).
  2. Accessing Raw Material Storage:
    • Retrieve raw materials from storage areas following First-In, First-Out (FIFO) or First-Expiry, First-Out (FEFO) principles.
    • Record retrieval details in the Material Retrieval Log (Annexure-2).

5.2 Batch Number Verification Process

  1. Physical Verification:
    • Physically inspect the label on the raw material container to verify the batch number.
    • Ensure that the batch number matches the BMR and purchase order details.
    • Record the verification in the Batch Number Verification Log (Annexure-3).
  2. Cross-Verification with Documentation:
    • Cross-verify the batch number with the Certificate of Analysis (COA), Goods Receipt Note (GRN), and other relevant documents.
    • Document the cross-verification in the Document Verification Log (Annexure-4).

5.3 Handling Discrepancies in Batch Verification

  1. Identification of Discrepancies:
    • If any discrepancies are found between the batch number on the raw material and the BMR, report immediately to QA.
    • Document discrepancies in the Discrepancy Log (Annexure-5).
  2. Corrective Actions:
    • Take corrective actions as recommended by QA, such as re-verification or rejection of the material.
    • Document corrective actions in the Corrective Action Log (Annexure-6).

5.4 Labeling and Issuance of Verified Materials

  1. Labeling of Verified Materials:
    • Label materials with “Verified” tags after successful batch number verification.
    • Record labeling in the Labeling Log (Annexure-7).
  2. Issuance of Verified Materials:
    • Issue only verified materials to the production department as per the BMR.
    • Document issuance details in the Material Issuance Log (Annexure-8).

5.5 Training and Compliance Audits

  1. Training on Batch Verification:
    • Conduct regular training sessions for warehouse and production staff on batch verification procedures.
    • Document training in the Training Log (Annexure-9).
  2. Compliance Audits:
    • QA performs periodic audits to ensure compliance with batch verification procedures.
    • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • FIFO: First-In, First-Out
  • FEFO: First-Expiry, First-Out
  • COA: Certificate of Analysis
  • GRN: Goods Receipt Note

7. Documents

  1. BMR Review Log (Annexure-1)
  2. Material Retrieval Log (Annexure-2)
  3. Batch Number Verification Log (Annexure-3)
  4. Document Verification Log (Annexure-4)
  5. Discrepancy Log (Annexure-5)
  6. Corrective Action Log (Annexure-6)
  7. Labeling Log (Annexure-7)
  8. Material Issuance Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on GMP for Pharmaceutical Products
  • FDA Guidance on Material Verification Procedures

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Review Log

Date BMR Number Reviewed By Remarks
02/05/2025 BMR-78945 Ravi Kumar Reviewed and Approved

Annexure-2: Material Retrieval Log

Date Material Name Batch Number Retrieved By
02/05/2025 Ibuprofen API BN-12345 Neha Verma

Annexure-3: Batch Number Verification Log

Date Material Name Batch Number Verified By
02/05/2025 Ibuprofen API BN-12345 Amit Joshi

Annexure-4: Document Verification Log

Date Document Type Batch Number Verified By
02/05/2025 COA BN-12345 QA Team

Annexure-5: Discrepancy Log

Date Discrepancy Identified Description Reported By
02/05/2025 Mismatched Batch Number Batch on container does not match BMR QA Team

Annexure-6: Corrective Action Log

Date Issue Corrective Action Taken Performed By
02/05/2025 Mismatched Batch Number Re-issued correct batch Warehouse Staff

Annexure-7: Labeling Log

Date Material Name Label Information Labeled By
02/05/2025 Ibuprofen API Batch BN-12345, Verified Ravi Kumar

Annexure-8: Material Issuance Log

Date Material Name Batch Number Issued To
02/05/2025 Ibuprofen API BN-12345 Production Department

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
02/05/2025 Neha Verma Batch Verification Procedures QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
02/05/2025 2.0 Added cross-verification and discrepancy handling procedures. Regulatory Update QA Head
]]> SOP for Raw Material Issuance Based on Batch Manufacturing Record (BMR) – V 2.0 https://www.pharmasop.in/sop-for-raw-material-issuance-based-on-batch-manufacturing-record-bmr-v-2-0/ Fri, 16 May 2025 15:46:00 +0000 https://www.pharmasop.in/?p=8600 Read More “SOP for Raw Material Issuance Based on Batch Manufacturing Record (BMR) – V 2.0” »

]]> SOP for Raw Material Issuance Based on Batch Manufacturing Record (BMR) – V 2.0

Standard Operating Procedure for Raw Material Issuance Based on Batch Manufacturing Record (BMR)

Department Warehouse / Production / Quality Assurance
SOP No. SOP/RM/196/2025
Supersedes SOP/RM/196/2022
Page No. Page 1 of 15
Issue Date 01/05/2025
Effective Date 08/05/2025
Review Date 01/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for the accurate issuance of raw materials from the warehouse to production based on the Batch Manufacturing Record (BMR) to ensure traceability, compliance with Good Manufacturing Practices (GMP), and product quality.

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the issuance, verification, and documentation of raw materials based on BMR requirements.

3. Responsibilities

  • Warehouse Staff: Issue raw materials according to BMR specifications and ensure accurate documentation.
  • Production Supervisor: Verify that issued materials match BMR requirements before use in production.
  • Quality Assurance (QA) Team: Oversee compliance with issuance protocols and perform audits.

4. Accountability

The Warehouse Manager is accountable for the proper issuance of raw materials. The Production Supervisor ensures that only correctly issued materials are used in manufacturing, while the QA Manager verifies compliance through regular audits.

5. Procedure

5.1 Receipt and Review of BMR

  1. BMR Submission:
    • The Production Department submits the approved BMR to the Warehouse for raw material issuance.
    • Record BMR receipt in the BMR Receipt Log (Annexure-1).
  2. BMR Review:
    • The Warehouse Supervisor reviews the BMR for completeness and authorization before issuing materials.
    • Document BMR review details in the BMR Review Log (Annexure-2).

5.2 Raw Material Issuance Process

  1. Material Selection:
    • Select raw materials based on the batch number, quantity, and specifications in the BMR, following FIFO (First-In, First-Out) or FEFO (First-Expiry, First-Out) principles.
    • Record material selection in the Material Selection Log (Annexure-3).
  2. Material Weighing:
    • Weigh the raw materials according to the BMR instructions using calibrated equipment.
    • Document weighing details in the Weighing Log (Annexure-4).

5.3 Verification and Documentation

  1. Cross-Verification:
    • The Production Supervisor or designated QA personnel verifies the materials against the BMR for correct batch numbers, quantities, and specifications.
    • Log verification details in the Verification Log (Annexure-5).
  2. Labeling of Issued Materials:
    • Label the issued materials with the batch number, material name, and weight as per BMR requirements.
    • Document labeling in the Material Labeling Log (Annexure-6).

5.4 Handling Discrepancies

  1. Identification of Discrepancies:
    • Any discrepancies between issued materials and BMR specifications must be reported immediately to the QA team.
    • Document discrepancies in the Discrepancy Log (Annexure-7).
  2. Corrective Actions:
    • Implement corrective actions for discrepancies, and document resolutions in the Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

  1. Staff Training:
    • Conduct training sessions on the proper issuance of raw materials based on BMR.
    • Document training sessions in the Training Log (Annexure-9).
  2. Compliance Audits:
    • QA personnel conduct periodic audits to ensure compliance with issuance procedures.
    • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • FIFO: First-In, First-Out
  • FEFO: First-Expiry, First-Out

7. Documents

  1. BMR Receipt Log (Annexure-1)
  2. BMR Review Log (Annexure-2)
  3. Material Selection Log (Annexure-3)
  4. Weighing Log (Annexure-4)
  5. Verification Log (Annexure-5)
  6. Material Labeling Log (Annexure-6)
  7. Discrepancy Log (Annexure-7)
  8. Corrective Action Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on GMP for Pharmaceutical Products
  • FDA Guidance on Batch Manufacturing Record Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Receipt Log

Date BMR Number Received By Production Batch Number
01/05/2025 BMR-45678 Ravi Kumar PB-00123

Annexure-2: BMR Review Log

Date BMR Number Reviewed By Remarks
01/05/2025 BMR-45678 Neha Verma Complete and Authorized

Annexure-3: Material Selection Log

Date Material Name Batch Number Selected By
01/05/2025 Acetaminophen API BN-78901 Amit Joshi

Annexure-4: Weighing Log

Date Material Name Weighed Quantity (kg) Weighed By
01/05/2025 Acetaminophen API 25 kg Kiran Patel

Annexure-5: Verification Log

Date Material Name Batch Number Verified By
01/05/2025 Acetaminophen API BN-78901 QA Team

Annexure-6: Material Labeling Log

Date Material Name Label Information Labeled By
01/05/2025 Acetaminophen API Batch BN-78901, 25 kg Ravi Kumar

Annexure-7: Discrepancy Log

Date Discrepancy Identified Description Reported By
01/05/2025 Incorrect Batch Number Mismatch between BMR and issued material QA Team

Annexure-8: Corrective Action Log

Date Issue Corrective Action Taken Performed By
01/05/2025 Incorrect Batch Issuance Re-issued correct batch Warehouse Staff

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
01/05/2025 Neha Verma Raw Material Issuance Based on BMR QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
01/05/2025 2.0 Added procedures for discrepancy handling and corrective actions. Regulatory Update QA Head
]]> SOP for Ensuring Proper Use of Warehouse Storage Automation Systems – V 2.0 https://www.pharmasop.in/sop-for-ensuring-proper-use-of-warehouse-storage-automation-systems-v-2-0/ Thu, 15 May 2025 23:56:00 +0000 https://www.pharmasop.in/?p=8599 Read More “SOP for Ensuring Proper Use of Warehouse Storage Automation Systems – V 2.0” »

]]> SOP for Ensuring Proper Use of Warehouse Storage Automation Systems – V 2.0

Standard Operating Procedure for Ensuring Proper Use of Warehouse Storage Automation Systems

Department Warehouse / Quality Assurance / IT Support
SOP No. SOP/RM/195/2025
Supersedes SOP/RM/195/2022
Page No. Page 1 of 15
Issue Date 30/04/2025
Effective Date 07/05/2025
Review Date 30/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the protocols for the proper use, maintenance, and monitoring of warehouse storage automation systems to ensure efficiency, accuracy, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse staff, IT personnel, and quality assurance teams involved in the operation, maintenance, and monitoring of automated storage systems within the warehouse.

3. Responsibilities

  • Warehouse Manager: Oversee the implementation and proper use of storage automation systems.
  • IT Support Team: Ensure the automation systems are operational, troubleshoot issues, and perform regular maintenance.
  • Quality Assurance (QA) Team: Audit system compliance with operational and regulatory requirements.

4. Accountability

The Warehouse Manager is accountable for ensuring proper use of the automation systems. The IT Support Team is responsible for system maintenance and troubleshooting, while the QA Manager conducts regular audits to ensure compliance.

5. Procedure

5.1 System Setup and Initialization

  1. System Configuration:
    • Ensure all automation systems are configured according to manufacturer specifications and GMP guidelines.
    • Document configuration settings in the System Configuration Log (Annexure-1).
  2. User Access Setup:
    • Assign system access levels based on job responsibilities and maintain a record of authorized users.
    • Record user access in the User Access Log (Annexure-2).

5.2 Operation of Warehouse Automation Systems

  1. Material Storage and Retrieval:
    • Ensure materials are stored and retrieved using automated systems to minimize manual handling and errors.
    • Log storage and retrieval activities in the Storage & Retrieval Log (Annexure-3).
  2. System Monitoring:
    • Regularly monitor the performance of automation systems to detect and address any anomalies.
    • Document monitoring activities in the System Monitoring Log (Annexure-4).

5.3 Troubleshooting and Maintenance

  1. Issue Identification:
    • Identify system malfunctions and log issues immediately in the Issue Identification Log (Annexure-5).
  2. System Maintenance:
    • Perform routine system maintenance according to the manufacturer’s guidelines to ensure optimal performance.
    • Record maintenance activities in the Maintenance Log (Annexure-6).

5.4 Data Integrity and Backup Procedures

  1. Data Entry Verification:
    • Ensure all data entries in the automation system are accurate and verified by a second operator.
    • Record verification activities in the Data Verification Log (Annexure-7).
  2. System Backup:
    • Perform regular data backups to secure system data and prevent loss.
    • Log backup activities in the Backup Log (Annexure-8).

5.5 Training and Compliance Audits

  1. System Training:
    • Provide comprehensive training to all users on the proper use of warehouse automation systems.
    • Document training sessions in the Training Log (Annexure-9).
  2. Compliance Audits:
    • Conduct periodic audits to ensure adherence to SOP guidelines and regulatory compliance.
    • Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • GMP: Good Manufacturing Practice
  • ERP: Enterprise Resource Planning

7. Documents

  1. System Configuration Log (Annexure-1)
  2. User Access Log (Annexure-2)
  3. Storage & Retrieval Log (Annexure-3)
  4. System Monitoring Log (Annexure-4)
  5. Issue Identification Log (Annexure-5)
  6. Maintenance Log (Annexure-6)
  7. Data Verification Log (Annexure-7)
  8. Backup Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 11 – Electronic Records; Electronic Signatures
  • GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
  • FDA Guidance for Industry on Warehouse Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: System Configuration Log

Date System Name Configuration Details Configured By
30/04/2025 Automated Storage Unit A Temperature set at 20°C, Humidity 45% Ravi Kumar

Annexure-2: User Access Log

Date Employee Name Access Level Authorized By
30/04/2025 Neha Verma Admin Warehouse Manager

Annexure-3: Storage & Retrieval Log

Date Material Name Action (Stored/Retrieved) Performed By
30/04/2025 Paracetamol API Stored Amit Joshi

Annexure-4: System Monitoring Log

Date System Name Status Checked By
30/04/2025 Automated Conveyor Operational Kiran Patel

Annexure-5: Issue Identification Log

Date Issue Identified Description Reported By
30/04/2025 System Freeze Storage unit unresponsive during retrieval Ravi Kumar

Annexure-6: Maintenance Log

Date System Name Maintenance Performed Performed By
30/04/2025 Automated Storage Unit A System Reboot and Software Update IT Support

Annexure-7: Data Verification Log

Date Data Verified Verification Method Verified By
30/04/2025 Paracetamol API Batch #12345 Double-Check Entry QA Team

Annexure-8: Backup Log

Date System Name Backup Type Performed By
30/04/2025 Warehouse Automation System Full Backup IT Support

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
30/04/2025 Neha Verma Warehouse Automation System Usage IT Support Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
30/04/2025 2.0 Included data integrity and backup procedures. Regulatory Update QA Head
]]> SOP for Establishing and Enforcing Warehouse Storage Safety Protocols – V 2.0 https://www.pharmasop.in/sop-for-establishing-and-enforcing-warehouse-storage-safety-protocols-v-2-0/ Thu, 15 May 2025 08:06:00 +0000 https://www.pharmasop.in/?p=8598 Read More “SOP for Establishing and Enforcing Warehouse Storage Safety Protocols – V 2.0” »

]]> SOP for Establishing and Enforcing Warehouse Storage Safety Protocols – V 2.0

Standard Operating Procedure for Establishing and Enforcing Warehouse Storage Safety Protocols

Department Warehouse / Quality Assurance / Safety
SOP No. SOP/RM/194/2025
Supersedes SOP/RM/194/2022
Page No. Page 1 of 15
Issue Date 29/04/2025
Effective Date 06/05/2025
Review Date 29/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for establishing and enforcing safety protocols in warehouse storage to prevent accidents, ensure compliance with regulatory standards, and maintain the integrity of raw materials.

2. Scope

This SOP applies to all warehouse personnel, including managers, operators, and safety officers responsible for the safe storage and handling of raw materials.

3. Responsibilities

  • Warehouse Manager: Implement safety protocols and ensure staff compliance.
  • Safety Officer: Monitor safety measures, conduct regular inspections, and provide safety training.
  • Quality Assurance (QA) Team: Audit safety compliance and recommend improvements.

4. Accountability

The Warehouse Manager is accountable for enforcing safety protocols. The Safety Officer ensures continuous monitoring and compliance, while the QA Manager conducts audits to verify adherence to safety standards.

5. Procedure

5.1 Development of Safety Protocols

  1. Identify Safety Hazards:
    • Conduct a risk assessment to identify potential hazards related to raw material storage.
    • Document identified hazards in the Hazard Identification Log (Annexure-1).
  2. Design Safety Measures:
    • Develop specific safety protocols to mitigate identified risks, including storage practices, equipment usage, and emergency procedures.
    • Record safety measures in the Safety Protocol Development Log (Annexure-2).

5.2 Implementation of Safety Protocols

  1. Safety Signage and Instructions:
    • Install clear signage in the warehouse indicating safety instructions, emergency exits, and hazard zones.
    • Document signage placement in the Safety Signage Log (Annexure-3).
  2. Use of Safety Equipment:
    • Ensure all personnel use appropriate Personal Protective Equipment (PPE) during operations.
    • Maintain records in the PPE Compliance Log (Annexure-4).

5.3 Monitoring and Enforcement

  1. Safety Inspections:
    • Conduct routine safety inspections to ensure compliance with established protocols.
    • Record inspection results in the Safety Inspection Log (Annexure-5).
  2. Incident Reporting:
    • Document all safety incidents, near-misses, and violations.
    • Log incidents in the Incident Report Log (Annexure-6).

5.4 Corrective Actions and Continuous Improvement

  1. Addressing Safety Violations:
    • Implement corrective actions for any safety violations or non-compliance.
    • Document actions taken in the Corrective Action Log (Annexure-7).
  2. Review and Update Protocols:
    • Periodically review and update safety protocols based on audit findings and regulatory changes.
    • Record updates in the Safety Protocol Review Log (Annexure-8).

5.5 Training and Awareness

  1. Staff Training:
    • Conduct regular training sessions for warehouse staff on safety protocols and emergency procedures.
    • Document training sessions in the Training Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Hazard Identification Log (Annexure-1)
  2. Safety Protocol Development Log (Annexure-2)
  3. Safety Signage Log (Annexure-3)
  4. PPE Compliance Log (Annexure-4)
  5. Safety Inspection Log (Annexure-5)
  6. Incident Report Log (Annexure-6)
  7. Corrective Action Log (Annexure-7)
  8. Safety Protocol Review Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • OSHA Warehouse Safety Guidelines
  • FDA Guidance for Warehouse Safety Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Hazard Identification Log

Date Hazard Identified Location Identified By
29/04/2025 Slippery Floor Loading Dock Ravi Kumar

Annexure-2: Safety Protocol Development Log

Date Protocol Developed Description Developed By
29/04/2025 Spill Response Procedure Steps to contain and clean chemical spills Safety Officer

Annexure-3: Safety Signage Log

Date Signage Installed Location Installed By
29/04/2025 Emergency Exit South Warehouse Exit Neha Verma

Annexure-4: PPE Compliance Log

Date Employee Name PPE Used Checked By
29/04/2025 Amit Joshi Gloves, Goggles, Safety Boots Safety Officer

Annexure-5: Safety Inspection Log

Date Area Inspected Findings Inspector
29/04/2025 Storage Zone A No Issues Found Kiran Patel

Annexure-6: Incident Report Log

Date Incident Type Description Reported By
29/04/2025 Minor Injury Slip on wet floor in loading dock Ravi Kumar

Annexure-7: Corrective Action Log

Date Issue Corrective Action Taken Performed By
29/04/2025 Slippery Floor Applied Anti-Slip Mats Maintenance Team

Annexure-8: Safety Protocol Review Log

Date Protocol Reviewed Changes Made Reviewed By
29/04/2025 Fire Evacuation Plan Added New Assembly Point QA Team

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
29/04/2025 Neha Verma Warehouse Safety Protocols Safety Officer Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
29/04/2025 2.0 Updated to include enhanced safety inspection and corrective action protocols. Regulatory Update QA Head
]]> SOP for Managing Warehouse Security and Preventing Unauthorized Access – V 2.0 https://www.pharmasop.in/sop-for-managing-warehouse-security-and-preventing-unauthorized-access-v-2-0/ Wed, 14 May 2025 16:16:00 +0000 https://www.pharmasop.in/?p=8597 Read More “SOP for Managing Warehouse Security and Preventing Unauthorized Access – V 2.0” »

]]> SOP for Managing Warehouse Security and Preventing Unauthorized Access – V 2.0

Standard Operating Procedure for Managing Warehouse Security and Preventing Unauthorized Access

Department Warehouse / Quality Assurance / Security
SOP No. SOP/RM/193/2025
Supersedes SOP/RM/193/2022
Page No. Page 1 of 15
Issue Date 28/04/2025
Effective Date 05/05/2025
Review Date 28/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the measures and protocols for managing warehouse security and preventing unauthorized access to ensure the safety and integrity of raw materials.

2. Scope

This SOP applies to all personnel, including warehouse staff, security personnel, and visitors, who have access to the warehouse premises where raw materials are stored.

3. Responsibilities

  • Warehouse Manager: Ensure that all security protocols are implemented and adhered to by warehouse staff.
  • Security Supervisor: Oversee security operations, manage access control systems, and monitor surveillance equipment.
  • Quality Assurance (QA) Team: Conduct periodic audits to ensure compliance with security protocols.

4. Accountability

The Warehouse Manager is accountable for overall security management in the warehouse. The Security Supervisor is responsible for enforcing access control measures, and the QA Manager ensures compliance through regular audits.

5. Procedure

5.1 Access Control Measures

  1. Authorization for Access:
    • Only authorized personnel with valid identification are permitted to enter the warehouse.
    • Document authorization in the Access Authorization Log (Annexure-1).
  2. Visitor Management:
    • All visitors must sign in at the security desk and be escorted by authorized personnel.
    • Record visitor details in the Visitor Log (Annexure-2).

5.2 Surveillance and Monitoring

  1. CCTV Surveillance:
    • Ensure all entry points, sensitive storage areas, and loading docks are covered by CCTV cameras.
    • Maintain surveillance footage records in the Surveillance Monitoring Log (Annexure-3).
  2. Alarm Systems:
    • Install motion detectors and alarm systems to detect unauthorized access.
    • Record alarm system tests and maintenance in the Alarm System Log (Annexure-4).

5.3 Handling Security Breaches

  1. Identifying Breaches:
    • Any unauthorized access attempts must be immediately reported to the Security Supervisor.
    • Document incidents in the Security Breach Log (Annexure-5).
  2. Response to Breaches:
    • Initiate emergency protocols in case of a security breach, including lockdown procedures if necessary.
    • Record corrective actions in the Corrective Action Log (Annexure-6).

5.4 Training and Compliance Audits

  1. Security Training:
    • Provide security training for all warehouse staff, including emergency response and access control procedures.
    • Record training sessions in the Training Log (Annexure-7).
  2. Compliance Audits:
    • Conduct periodic audits to verify compliance with security protocols.
    • Document audit results in the Compliance Audit Log (Annexure-8).

5.5 Maintenance of Security Systems

  1. System Checks:
    • Regularly inspect and maintain security systems, including CCTV cameras, access control systems, and alarms.
    • Document maintenance activities in the Security System Maintenance Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • CCTV: Closed-Circuit Television

7. Documents

  1. Access Authorization Log (Annexure-1)
  2. Visitor Log (Annexure-2)
  3. Surveillance Monitoring Log (Annexure-3)
  4. Alarm System Log (Annexure-4)
  5. Security Breach Log (Annexure-5)
  6. Corrective Action Log (Annexure-6)
  7. Training Log (Annexure-7)
  8. Compliance Audit Log (Annexure-8)
  9. Security System Maintenance Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • OSHA Warehouse Safety Guidelines
  • FDA Guidance for Securing Pharmaceutical Warehouses

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Access Authorization Log

Date Employee Name Access Level Authorized By
28/04/2025 Ravi Kumar Full Access Warehouse Manager

Annexure-2: Visitor Log

Date Visitor Name Purpose of Visit Escorted By
28/04/2025 Neha Verma Regulatory Inspection Amit Joshi

Annexure-3: Surveillance Monitoring Log

Date Camera Location Status Checked By
28/04/2025 Main Entrance Operational Kiran Patel

Annexure-4: Alarm System Log

Date System Tested Result Tested By
28/04/2025 Motion Detector Functional Security Team

Annexure-5: Security Breach Log

Date Breach Type Description Reported By
28/04/2025 Unauthorized Access Attempt Attempted Entry via Loading Dock Ravi Kumar

Annexure-6: Corrective Action Log

Date Issue Corrective Action Taken Performed By
28/04/2025 Unauthorized Access Strengthened Security Protocols Security Supervisor

Annexure-7: Training Log

Date Employee Name Training Topic Trainer Remarks
28/04/2025 Amit Joshi Warehouse Security Procedures QA Manager Completed Successfully

Annexure-8: Compliance Audit Log

Date Audit Area Findings Auditor
28/04/2025 Access Control System No Issues Found QA Team

Annexure-9: Security System Maintenance Log

Date System Name Maintenance Activity Performed By
28/04/2025 CCTV Cameras System Check and Cleaning Maintenance Team

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
28/04/2025 2.0 Updated with additional surveillance and breach handling procedures. Regulatory Update QA Head
]]> SOP for Proper Labeling and Documentation of Relocated Raw Materials – V 2.0 https://www.pharmasop.in/sop-for-proper-labeling-and-documentation-of-relocated-raw-materials-v-2-0/ Wed, 14 May 2025 00:26:00 +0000 https://www.pharmasop.in/?p=8596 Read More “SOP for Proper Labeling and Documentation of Relocated Raw Materials – V 2.0” »

]]> SOP for Proper Labeling and Documentation of Relocated Raw Materials – V 2.0

Standard Operating Procedure for Proper Labeling and Documentation of Relocated Raw Materials

Department Warehouse / Quality Assurance / Inventory Control
SOP No. SOP/RM/192/2025
Supersedes SOP/RM/192/2022
Page No. Page 1 of 15
Issue Date 27/04/2025
Effective Date 04/05/2025
Review Date 27/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the steps for proper labeling and documentation when relocating raw materials within the warehouse to ensure traceability, inventory accuracy, and GMP compliance.

2. Scope

This SOP applies to all warehouse staff involved in the relocation, labeling, and documentation of raw materials from one storage area to another within the facility.

3. Responsibilities

  • Warehouse Personnel: Ensure accurate labeling and documentation during relocation activities.
  • Inventory Control Team: Update inventory systems and verify the correctness of relocation data.
  • Quality Assurance (QA) Team: Conduct audits to ensure compliance with labeling and documentation protocols.

4. Accountability

The Warehouse Manager is accountable for ensuring all raw material relocations are properly labeled and documented. The Inventory Control Manager is responsible for maintaining up-to-date inventory records, and the QA Manager ensures compliance through regular audits.

5. Procedure

5.1 Planning for Raw Material Relocation

  1. Relocation Authorization:
    • Obtain written authorization from the Warehouse Manager before relocating any raw materials.
    • Record authorization details in the Relocation Authorization Log (Annexure-1).
  2. Pre-Relocation Checklist:
    • Ensure that the new storage area meets environmental and safety requirements.
    • Document pre-relocation checks in the Pre-Relocation Checklist Log (Annexure-2).

5.2 Labeling of Relocated Raw Materials

  1. Label Generation:
    • Generate new labels indicating the new storage location, date of relocation, and responsible personnel.
    • Record labeling details in the Labeling Log (Annexure-3).
  2. Label Application:
    • Apply new labels securely to raw material containers, ensuring old labels are not removed but clearly marked as superseded.
    • Document label application in the Label Application Log (Annexure-4).

5.3 Documentation of Raw Material Relocation

  1. Inventory System Update:
    • Update the inventory management system (ERP) with the new location and details of the raw material.
    • Document updates in the Inventory Update Log (Annexure-5).
  2. Physical Relocation Documentation:
    • Record the physical movement of raw materials in the Relocation Movement Log (Annexure-6).

5.4 Handling Discrepancies and Non-Conformances

  1. Identification of Discrepancies:
    • Report any discrepancies, such as mismatched batch numbers or incorrect labeling, immediately to the QA department.
    • Document discrepancies in the Non-Conformance Log (Annexure-7).
  2. Corrective Actions:
    • Implement corrective actions to resolve discrepancies and prevent recurrence.
    • Record corrective actions in the Corrective Action Log (Annexure-8).

5.5 Training and Compliance Monitoring

  1. Training:
    • Provide training to warehouse staff on proper relocation, labeling, and documentation procedures.
    • Record training sessions in the Training Log (Annexure-9).
  2. Compliance Audits:
    • Conduct regular audits to ensure adherence to this SOP and identify areas for improvement.
    • Document audit results in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • ERP: Enterprise Resource Planning

7. Documents

  1. Relocation Authorization Log (Annexure-1)
  2. Pre-Relocation Checklist Log (Annexure-2)
  3. Labeling Log (Annexure-3)
  4. Label Application Log (Annexure-4)
  5. Inventory Update Log (Annexure-5)
  6. Relocation Movement Log (Annexure-6)
  7. Non-Conformance Log (Annexure-7)
  8. Corrective Action Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Good Storage Practices for Pharmaceuticals
  • FDA Guidance for Industry: Computerized Systems Used in Warehouse Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Relocation Authorization Log

Date Material Name Authorized By Relocation Reason
27/04/2025 Acetaminophen API Warehouse Manager Space Optimization

Annexure-2: Pre-Relocation Checklist Log

Date Material Name Storage Conditions Verified Checked By
27/04/2025 Acetaminophen API Yes Ravi Kumar

Annexure-3: Labeling Log

Date Material Name New Label Generated Labeled By
27/04/2025 Acetaminophen API Relocation Label – Zone B Neha Verma

Annexure-4: Label Application Log

Date Material Name Old Label Status New Label Applied By
27/04/2025 Acetaminophen API Superseded Amit Joshi

Annexure-5: Inventory Update Log

Date Material Name New Location Updated Updated By
27/04/2025 Acetaminophen API Zone B, Shelf 3 Kiran Patel

Annexure-6: Relocation Movement Log

Date Material Name From To Moved By
27/04/2025 Acetaminophen API Zone A Zone B Amit Joshi

Annexure-7: Non-Conformance Log

Date Material Name Non-Conformance Details Reported By
27/04/2025 Acetaminophen API Labeling Error – Incorrect Batch Number Ravi Kumar

Annexure-8: Corrective Action Log

Date Non-Conformance Corrective Action Taken Performed By
27/04/2025 Labeling Error Reprinted Correct Label QA Team

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
27/04/2025 Ravi Kumar Labeling and Documentation Procedures QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
27/04/2025 2.0 Updated to include non-conformance and corrective action processes. Regulatory Update QA Head
]]> SOP for Secure Storage and Access Control for High-Purity Solvents – V 2.0 https://www.pharmasop.in/sop-for-secure-storage-and-access-control-for-high-purity-solvents-v-2-0/ Tue, 13 May 2025 08:36:00 +0000 https://www.pharmasop.in/?p=8595 Read More “SOP for Secure Storage and Access Control for High-Purity Solvents – V 2.0” »

]]> SOP for Secure Storage and Access Control for High-Purity Solvents – V 2.0

Standard Operating Procedure for Secure Storage and Access Control for High-Purity Solvents

Department Warehouse / Quality Assurance / Safety
SOP No. SOP/RM/191/2025
Supersedes SOP/RM/191/2022
Page No. Page 1 of 15
Issue Date 26/04/2025
Effective Date 03/05/2025
Review Date 26/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the secure storage and controlled access of high-purity solvents to ensure product integrity, safety, and regulatory compliance.

2. Scope

This SOP applies to all personnel involved in the storage, handling, and monitoring of high-purity solvents within the warehouse environment, including temperature-controlled storage zones and restricted access areas.

3. Responsibilities

  • Warehouse Manager: Ensure secure storage conditions are maintained and access is controlled as per the SOP.
  • Quality Assurance (QA) Team: Conduct periodic audits to verify compliance with storage and access control requirements.
  • Safety Officer: Oversee the implementation of safety protocols for handling high-purity solvents.

4. Accountability

The Warehouse Manager is accountable for ensuring that high-purity solvents are stored securely and that access is restricted. The QA Manager is responsible for auditing compliance, while the Safety Officer ensures adherence to safety protocols.

5. Procedure

5.1 Storage Requirements for High-Purity Solvents

  1. Designated Storage Areas:
    • Store high-purity solvents in dedicated, well-ventilated, and explosion-proof storage cabinets or rooms.
    • Document storage locations in the Solvent Storage Log (Annexure-1).
  2. Environmental Control:
    • Maintain specified temperature and humidity conditions as per solvent requirements.
    • Record environmental monitoring in the Environmental Monitoring Log (Annexure-2).

5.2 Access Control Measures

  1. Restricted Access Protocol:
    • Limit access to authorized personnel only, using key cards or biometric systems.
    • Document access permissions in the Access Authorization Log (Annexure-3).
  2. Access Log Maintenance:
    • Maintain an entry and exit log for all personnel accessing the solvent storage area.
    • Record entries in the Access Control Log (Annexure-4).

5.3 Handling and Transfer of High-Purity Solvents

  1. Use of Personal Protective Equipment (PPE):
    • Ensure all personnel handling solvents wear appropriate PPE, including gloves, goggles, and lab coats.
    • Document PPE compliance in the PPE Compliance Log (Annexure-5).
  2. Safe Transfer Procedures:
    • Transfer solvents using grounded containers and follow standard safety protocols to prevent spills or contamination.
    • Record transfers in the Solvent Transfer Log (Annexure-6).

5.4 Emergency Response and Spill Management

  1. Spill Response Procedures:
    • In the event of a spill, immediately contain the solvent using spill kits and report the incident.
    • Document spills in the Spill Incident Log (Annexure-7).
  2. Emergency Equipment:
    • Ensure fire extinguishers, eyewash stations, and emergency showers are accessible in storage areas.
    • Record maintenance of emergency equipment in the Emergency Equipment Maintenance Log (Annexure-8).

5.5 Training and Compliance Audits

  1. Personnel Training:
    • Provide training to all authorized personnel on solvent handling, storage protocols, and emergency procedures.
    • Document training sessions in the Training Log (Annexure-9).
  2. Compliance Audits:
    • Conduct quarterly audits to ensure adherence to SOP protocols and regulatory requirements.
    • Record audit results in the Compliance Audit Log (Annexure-9).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Solvent Storage Log (Annexure-1)
  2. Environmental Monitoring Log (Annexure-2)
  3. Access Authorization Log (Annexure-3)
  4. Access Control Log (Annexure-4)
  5. PPE Compliance Log (Annexure-5)
  6. Solvent Transfer Log (Annexure-6)
  7. Spill Incident Log (Annexure-7)
  8. Emergency Equipment Maintenance Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • OSHA Guidelines for Chemical Safety and Solvent Storage
  • WHO Good Storage Practices for Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Solvent Storage Log

Date Solvent Name Storage Location Stored By
26/04/2025 Acetonitrile (99.9%) Explosion-Proof Cabinet A Ravi Kumar

Annexure-2: Environmental Monitoring Log

Date Storage Area Temperature (°C) Humidity (%) Checked By
26/04/2025 Solvent Room 1 20°C 45% Neha Verma

Annexure-3: Access Authorization Log

Date Employee Name Access Level Authorized By
26/04/2025 Amit Joshi Full Access Warehouse Manager

Annexure-4: Access Control Log

Date Employee Name Entry Time Exit Time
26/04/2025 Ravi Kumar 09:00 AM 09:30 AM

Annexure-5: PPE Compliance Log

Date Employee Name PPE Used Checked By
26/04/2025 Neha Verma Gloves, Lab Coat, Goggles Safety Officer

Annexure-6: Solvent Transfer Log

Date Solvent Name From To Transferred By
26/04/2025 Acetonitrile (99.9%) Storage Room QC Lab Amit Joshi

Annexure-7: Spill Incident Log

Date Solvent Name Spill Description Cleaned By
26/04/2025 Methanol (99.8%) Minor spill during transfer Kiran Patel

Annexure-8: Emergency Equipment Maintenance Log

Date Equipment Name Maintenance Activity Performed By
26/04/2025 Eyewash Station Tested and Cleaned Safety Team

Annexure-9: Training Log

Date Employee Name Training Topic Trainer Remarks
26/04/2025 Ravi Kumar Safe Handling and Storage of Solvents QA Manager Completed Successfully

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
26/04/2025 2.0 Added access control protocols and emergency response procedures. Regulatory Update QA Head
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