cross-contamination, and proper documentation as per GMP guidelines.

2. Scope

This SOP applies to all activities involving the weighing and dispensing of APIs intended for use in gel products manufactured in the Gel Manufacturing department. It includes activities performed by warehouse staff, production personnel, and quality assurance personnel.

3. Responsibilities

• Dispensing Operator: Responsible for correct weighing and labeling of APIs.
• Production Supervisor: Monitors dispensing, ensures accuracy, and verifies calculations.
• QA Officer: Verifies API identity, approves pre- and post-dispensing steps, and authorizes release.

4. Accountability

The Head of Manufacturing is accountable for ensuring that API dispensing follows GMP-compliant practices, minimizes error risk, and maintains full traceability of critical materials.

5. Procedure

5.1 Preparation

1. Review the manufacturing requisition form and confirm API name, code, batch number, and quantity required as per BMR.
2. Verify QA release status of the API and ensure that the CoA is attached and valid.
3. Perform line clearance and environmental cleaning of the weighing area.
4. Calibrate the balance or verify the calibration status and record the balance ID in the log.

5.2 Weighing of API

1. Wear cleanroom attire and gloves as per gowning SOP to prevent contamination.
2. Weigh APIs in a designated area equipped with dust extraction or laminar airflow.
3. Use clean, dry containers with tamper-evident seals to collect the weighed API.
4. Ensure minimum handling time and close all containers immediately after use.
5. Weigh the exact quantity required, noting target vs actual weight in the API Dispensing Log (Annexure-1).

5.3 Cross-Verification

1. Production Supervisor cross-verifies:
   • API name and code
   • Batch number
   • Expiry date
   • Quantity weighed
2. Supervisor initials the dispensing label and completes the Verification Sheet (Annexure-2).

5.4 Labeling

1. Label the dispensed API container with:
   • Material Name & Code
   • Batch Number
   • Weighed Quantity
   • Date of Dispensing
   • Signatures of Operator and Verifier
2. Affix “For Internal Use Only” and “Potent Material – Handle With Care” if applicable.

5.5 QA Review and Release

1. QA reviews all documents and physically inspects the labeled container.
2. Signs the Approval and Release Form (Annexure-3) for further processing.

5.6 Documentation

1. Attach all related documents (log, verification sheet, CoA, and release form) to the BMR.
2. Ensure all entries are in permanent ink and corrections are countersigned.
3. Maintain records for a minimum of 5 years or as per regulatory guidance.

5.7 Safety Measures

1. Handle APIs using proper PPE including masks, gloves, and safety goggles.
2. In case of spillage, follow spill control SOP and notify QA immediately.
3. Dispose of residual material or cleaning waste as per hazardous waste protocol.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• CoA: Certificate of Analysis
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. API Dispensing Log – Annexure-1
2. Verification Sheet – Annexure-2
3. Approval and Release Form – Annexure-3

8. References

• WHO Technical Report Series 986
• ICH Q7 – GMP for APIs
• Schedule M – Drugs and Cosmetics Rules

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: API Dispensing Log

Date	API Name	Batch No.	Qty Required (g)	Qty Weighed (g)	Operator
02/06/2025	Ketoconazole	KCNZ0525	500	498.5	Rajesh Kumar

Annexure-2: Verification Sheet

Checked Parameter	Observation	Verified By	Date
API Name/Code	Correct	Sunita Reddy	02/06/2025
Batch Number	Match	Sunita Reddy	02/06/2025
Weighed Quantity	Accurate	Sunita Reddy	02/06/2025

Annexure-3: Approval and Release Form

Material	Ketoconazole
Batch No.	KCNZ0525
Qty Released	498.5 g
Released By	QA Officer
Date	02/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Updated verification process and added detailed safety protocol	Annual Review	QA Head