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