Elixir Department: SOP for Verification of Raw Material Identity and Quantity – V 2.0

Posted on By

Elixir Department: SOP for Verification of Raw Material Identity and Quantity – V 2.0

Standard Operating Procedure for Raw Material Identity and Quantity Verification

Department Elixir Department
SOP No. SOP/ELX/026/2025
Supersedes SOP/ELX/026/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

The purpose of this SOP is to ensure that the identity and quantity of raw materials received for elixir manufacturing are verified thoroughly and accurately before dispensing or use. This verification helps prevent errors in manufacturing and ensures regulatory compliance.

2. Scope

This SOP applies to all raw materials received and used in the Elixir Department, including active pharmaceutical ingredients (APIs), excipients, solvents, and other additives. It covers the verification activities performed before storage or dispensing.

3. Responsibilities

  • Stores Personnel:
    • Receive raw materials and carry out preliminary checks on delivery documents.
    • Place materials in the quarantine area for further verification.
  • Quality Control (QC) Personnel:
    • Perform identity testing of materials and verify documentation.
  • Production Pharmacist:
    • Verify quantity as per batch requirements and ensure correct labeling.

4. Accountability

The Head of the Elixir Department is accountable for the implementation of this SOP and ensuring that raw material verification is conducted according to GMP standards.

See also  Elixir Department: SOP for Material Movement Record Maintenance - V 2.0

5. Procedure

5.1 Receiving and Preliminary Inspection

  1. Upon receipt, verify that the delivery is as per the purchase order (PO) by checking the delivery note and invoice.
  2. Inspect the outer packaging for physical damage, labeling errors, or tampering. In case of discrepancies, report to the Quality Assurance (QA) department.
  3. Check that labels on the material containers include:
    • Material Name
    • Manufacturer Name
    • Batch Number
    • Manufacturing and Expiry Dates
    • Storage Conditions
  4. Segregate damaged or incorrect containers for further investigation.

5.2 Documentation and Verification

  1. Ensure the Certificate of Analysis (CoA), Safety Data Sheet (SDS), and transport records are present.
  2. Verify the batch number and quantity mentioned in the CoA against the physical stock.
  3. Perform sampling as per SOP for sampling of raw materials and forward samples to the QC laboratory.
  4. QC will perform identification testing using validated methods and compare results with pharmacopeial specifications.
  5. Approval status shall be given on the container using a green ‘Approved’ label, and records shall be updated.
See also  Elixir Department: SOP for Environmental Conditions for Dispensing of Elixirs - V 2.0

5.3 Dispensing and Handling of Materials

  1. Once the material is approved, weigh the required quantity using calibrated balances.
  2. Use clean, dry, and labeled containers for transferring dispensed quantities.
  3. Ensure no cross-contamination or mix-up occurs during weighing.
  4. Affix proper dispensing labels indicating:
    • Material Name
    • Quantity Dispensed
    • Date
    • Done By

5.4 Labeling, Approval, and Release of Materials

  1. QC to review analytical results and provide approval based on compliance with specifications.
  2. Label containers with approved/rejected/quarantined status as applicable.
  3. Approved materials are transferred to the approved storage area for use in manufacturing.

5.5 Documentation and Record-Keeping

  1. Record all details in the Material Dispensing Log (Annexure-1) and Approval and Release Form (Annexure-3).
  2. Maintain copies of CoA and sampling reports with each material batch record (Annexure-2).
  3. All records should be signed and dated by responsible personnel.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QC: Quality Control
  • QA: Quality Assurance
  • CoA: Certificate of Analysis
  • SDS: Safety Data Sheet
  • PO: Purchase Order

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)

See also  Elixir Department: SOP for Environmental Monitoring of Dispensing Area - V 2.0

8. References

  • ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • WHO GMP Guidelines: Quality Assurance of Pharmaceuticals
  • 21 CFR Part 211: US FDA CGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Name Batch No. Quantity Verified By Remarks
10/04/2025 Citric Acid CA7895 2.5 kg Rajesh Kumar OK
10/04/2025 Sorbitol Solution SB4509 5.0 L Sunita Reddy No issues

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Result Complies
Citric Acid CA7895 Assay 99.5% Yes
Sorbitol Solution SB4509 Microbial Load Pass Yes

Annexure-3: Approval and Release Form

Date Material Name Batch No. Released By Approved By Status
11/04/2025 Citric Acid CA7895 Rajesh Kumar Manoj Verma Approved
11/04/2025 Sorbitol Solution SB4509 Sunita Reddy Manoj Verma Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release First SOP issuance QA Head
11/04/2025 2.0 Format and Compliance Update Updated to new SOP structure QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,