that any required filings are done.

4. Accountability

The QA Manager is accountable for ensuring that all documentation is reviewed and approved in compliance with GMP and regulatory guidelines. The Production and QC Managers are responsible for ensuring that their respective teams submit accurate and complete documentation for review.

5. Procedure

5.1 Documentation Creation

1. The Production Team is responsible for generating documentation during the manufacturing process. This includes:
   • Batch Manufacturing Records (BMR)
   • Ingredient Usage Logs
   • Process Parameter Logs
2. The QC Team generates documentation related to testing, such as:
   • Test Reports
   • Raw Material Inspection Logs
   • Finished Product Test Results
3. All generated documents must be completed in real time, with accurate data entered as the process occurs. Documents must be legible, signed, and dated by the responsible person.

5.2 QA Review

1. The QA Team will review the submitted documents to ensure that they meet all of the following criteria:
   • Accuracy and completeness of information
   • Consistency with standard operating procedures (SOPs) and regulations
   • Proper signatures and dates
   • Compliance with GMP guidelines
2. The QA team will also verify that any deviations or discrepancies are documented and investigated according to the applicable SOPs.
3. If any issues are identified during the review, the QA team will notify the responsible department (Production, QC) and request corrections or clarifications.

5.3 Approval of Documentation

1. Once the QA team has reviewed the documentation and confirmed its compliance with all requirements, they will approve it for finalization.
2. The QA Manager will sign off on all documents that are approved. If necessary, a secondary review or approval may be required depending on the nature of the document (e.g., regulatory filings, change control documents).
3. If the documentation is found to be incomplete or non-compliant, the QA team will return the document to the respective department with a request for corrections. The corrected document must be resubmitted for review and approval.

5.4 Handling Rejected Documentation

1. If documentation is rejected, the QA team will provide clear feedback to the responsible department regarding the reasons for rejection.
2. The responsible department must make the necessary corrections or provide additional documentation as required. The revised document is then resubmitted to the QA team for approval.
3. Rejected documentation should be properly archived with the reason for rejection documented in the record to maintain traceability.

5.5 Finalization and Archiving

1. Once documentation is approved, the document will be finalized, and copies will be distributed to the appropriate departments (e.g., Production, QC, Regulatory Affairs).
2. Approved documentation will be stored in a secure, controlled environment to ensure that it is retrievable and protected from unauthorized access, loss, or alteration.
3. Documents must be retained for a minimum of two years or as per regulatory guidelines, whichever is longer. Archived documents must be organized and maintained in a manner that allows easy retrieval for audits or inspections.

5.6 Documentation Control

1. All documents must be properly controlled, and any updates or revisions to documents must follow a structured revision control process.
2. Changes to documents, including SOPs, batch records, and testing protocols, must be reviewed and approved by the QA team before implementation.
3. Old or obsolete documents must be removed from active use and stored as historical records, clearly marked as outdated.

6. Abbreviations

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

7. Documents

1. Annexure-1: Deviation Report
2. Annexure-2: CAPA Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Documentation and Record Keeping

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Batch Number	Deviation Description	Corrective Action Taken	Resolved By	Resolution Date
12345	Deviation in pH during mixing	Adjusted mixing process, re-tested pH	QA Head	22/01/2026

Annexure-2: CAPA Log

Corrective Action Description	Preventive Action Description	Implementation Date	Responsible Person
Recalibrated mixing equipment	Scheduled regular equipment calibration	23/01/2026	Maintenance Supervisor

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head