Control Team: Responsible for maintaining all PQR-related documentation and ensuring that the records are accessible for audits and inspections.

4. Accountability

The QA Manager is accountable for ensuring that the PQR process is conducted in accordance with this SOP and that appropriate corrective actions are implemented based on the findings.

5. Procedure

5.1 Scheduling of PQRs

1. PQRs will be conducted at least once annually for each cream product. The schedule for conducting PQRs will be planned and documented by the QA Manager.
2. The PQR process should be initiated at least one month prior to the review date to ensure all necessary data is gathered and reviewed.

5.2 Data Collection for PQR

1. The following data will be collected and reviewed during the PQR:
   • Batch records for each production run, including raw material usage, equipment settings, and environmental conditions.
   • Test results from in-process controls, quality control testing, and final product testing.
   • Results from stability studies, if applicable.
   • Any deviations or non-conformities encountered during production, along with corrective and preventive actions (CAPA) implemented.
   • Customer feedback, including complaints and returns related to product quality.
   • Trend analysis data for key quality attributes such as viscosity, pH, microbial content, and packaging integrity.
2. The Document Control Team will ensure that all relevant documents are collected and made available for the PQR review.

5.3 Review and Analysis of Data

1. The QA Manager, in collaboration with the Production Team, will review all collected data to identify any trends, deviations, or potential quality issues.
2. Trends in quality data will be analyzed to determine if there are any recurring issues or if improvements can be made to the manufacturing process.
3. Any deviations or non-conformities will be thoroughly investigated, and the effectiveness of corrective actions will be evaluated.
4. If necessary, the team will consult with the Regulatory Affairs Team to ensure compliance with applicable regulations and guidelines.

5.4 Reporting of PQR Results

1. After reviewing and analyzing the data, the QA Manager will compile a PQR report that includes the following:
   • A summary of the data reviewed, including batch records, testing results, and stability data.
   • An evaluation of the effectiveness of previous corrective actions.
   • Identification of trends or recurring issues, along with recommendations for corrective actions or process improvements.
   • Customer feedback summary, including any actions taken in response to complaints or returns.
2. The PQR report will be reviewed by the QA Manager and, if necessary, the Regulatory Affairs Team for regulatory compliance.
3. The final PQR report will be distributed to relevant departments, including Production, Regulatory Affairs, and Document Control.

5.5 Corrective and Preventive Actions (CAPA)

1. If the PQR identifies any quality issues or trends that require corrective or preventive actions, the QA Manager will initiate a CAPA process.
2. The CAPA process will include:
   • Identification of the root cause of the quality issue
   • Implementation of corrective actions to address the issue
   • Preventive actions to avoid recurrence of the issue
   • Monitoring and verification of the effectiveness of the actions taken
3. The CAPA process will be documented in the CAPA Report (Annexure-1) and reviewed by the QA Manager before implementation.

5.6 Documentation and Record-Keeping

1. All PQR-related documents, including the PQR report, CAPA reports, and supporting data, will be maintained in accordance with GMP guidelines.
2. Records of the PQR and related actions will be stored securely and retained for a minimum of five years or as required by regulatory guidelines.
3. The Document Control Team will ensure that PQR records are easily accessible for audits and regulatory inspections.

5.7 Follow-Up and Monitoring

1. The QA Manager will ensure that any actions identified in the PQR are implemented and monitored for effectiveness.
2. Follow-up reviews will be conducted as necessary to ensure that corrective and preventive actions are effective and that the identified trends do not reoccur.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• PQR: Product Quality Review
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: CAPA Report Template
2. Annexure-2: Product Quality Review Report Template
3. Annexure-3: Corrective Action Monitoring 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: Quality Systems and Control

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: CAPA Report Template

Issue	Corrective Action	Preventive Action	Responsible Person	Completion Date
Viscosity variation	Re-calibration of mixing equipment	Quarterly equipment checks	Production Manager	21/02/2026

Annexure-2: Product Quality Review Report Template

Product	Year	Batch Records Reviewed	Test Results Reviewed	Corrective Actions
Cream A	2025	5 Batches	Passed all test criteria	None

Annexure-3: Corrective Action Monitoring Log

Action	Responsible Person	Status	Completion Date
Re-calibration of viscosity measurement	John Doe	Completed	21/02/2026

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