operations during the manufacturing and packaging of APIs. It covers activities such as equipment line clearance, process verification, batch record checks, sampling supervision, and labeling verification.

3. Responsibilities

• QA Officer/Executive: Performs in-process checks, line clearance, and documentation verification.
• QA Manager: Ensures timely QA presence and review, approves final records, and assesses observations.
• Production/Packaging Department: Executes operations in compliance with SOPs and informs QA for verification stages.

4. Accountability

The QA Head is accountable for maintaining QA presence throughout the manufacturing and packaging processes and for addressing any quality risks identified during oversight.

5. Procedure

5.1 QA Presence in Manufacturing and Packaging Areas

1. QA personnel must be available during:
   • Start of batch processing
   • Critical manufacturing steps (charging, filtration, drying)
   • Packaging activities (filling, labeling, sealing)
2. Record presence using QA Monitoring Logbook (Annexure-1).

5.2 Equipment Line Clearance

1. QA shall verify that the manufacturing/packaging area is clean, and equipment is labeled as “Cleaned.”
2. Check for absence of material from previous batches, proper cleaning documentation, and status labels.
3. Use Line Clearance Checklist (Annexure-2) and sign in the Batch Manufacturing Record (BMR).

5.3 Process Stage Verification

1. QA shall:
   • Verify material identity before charging
   • Confirm process parameters against BMR
   • Cross-check calculations and equipment calibration records
2. Verify that environmental conditions are within limits as recorded by EMS or manual logs.

5.4 Sampling Oversight

1. QA must witness or supervise sampling of intermediates and final product for IPC and QC testing.
2. Ensure proper labeling, quantity, sampling tool sanitation, and sample integrity.
3. Document QA presence in Sampling Observation Log (Annexure-3).

5.5 Packaging Operations Oversight

1. QA shall verify:
   • Correct batch details on packaging labels
   • Cleanliness and integrity of filling/sealing equipment
   • Label reconciliation records
   • Usage of correct container-closure system
2. Perform visual checks for filled containers and labeling accuracy.
3. Record observations in the Packaging Oversight Checklist (Annexure-4).

5.6 In-Process Record Review

1. QA shall review completed BMRs/BPRs in real time to ensure:
   • Entries are legible, dated, and signed
   • Deviations are captured with appropriate documentation
   • Critical parameters have been met and recorded
2. Any missing or questionable entries must be discussed with production and corrected per GDP principles.

5.7 Handling Deviations and Non-Conformances

1. QA must immediately escalate and record any deviations from procedure or quality events.
2. Initiate deviation reports as per SOP and participate in root cause analysis and CAPA implementation.

5.8 Final Batch Review and Approval

1. After all operations and QA reviews are completed:
   • QA Manager shall conduct a thorough review of BMR and test reports
   • Approve the batch for release or hold for further investigation

6. Abbreviations

• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• BPR: Batch Packaging Record
• IPC: In-Process Control
• CAPA: Corrective and Preventive Action
• GDP: Good Documentation Practices

7. Documents

1. QA Monitoring Logbook (Annexure-1)
2. Line Clearance Checklist (Annexure-2)
3. Sampling Observation Log (Annexure-3)
4. Packaging Oversight Checklist (Annexure-4)
5. Deviation Form (Annexure-5)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Subparts D, F, and J
• EU GMP Part II – Quality Control and Production

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: QA Monitoring Logbook

Date	Batch No.	Area	QA Personnel	Remarks
12/04/2025	API2025-01	Drying Room	Sunita Reddy	Environmental check OK

Annexure-2: Line Clearance Checklist

Parameter	Checked	Comments
Equipment cleaned and labeled	Yes	Accepted
No material from previous batch	Yes	Compliant

Annexure-3: Sampling Observation Log

Batch No.	Sampled Material	QA Observer	Date/Time
API2025-02	Wet Cake	Rajesh Kumar	13/04/2025 11:00 AM

Annexure-4: Packaging Oversight Checklist

Parameter	Status	Comments
Correct labeling	Yes	Batch details correct
Seal integrity	Yes	No damage observed

Annexure-5: Deviation Form

Deviation ID	Batch	Description	Action Taken	Status
DEV/2025/05	API2025-01	Late sampling	CAPA initiated	Open

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Expanded oversight procedures and new annexures	GMP Updates	QA Head