ensures that corrective actions are taken when necessary.

Regulatory Affairs Team: Responsible for ensuring that the manufacturing processes and products comply with external regulatory requirements, including filing necessary documents with regulatory agencies.

4. Accountability

The QA Manager is accountable for ensuring that GMP compliance is maintained throughout the cream manufacturing process. The Production Manager is responsible for ensuring that all production activities comply with GMP guidelines, while the QC Manager ensures that testing and inspection activities adhere to GMP standards.

5. Procedure

5.1 GMP Training and Awareness

1. All employees involved in the cream manufacturing process must receive regular GMP training. This includes production, QC, and packaging personnel.
2. Training should cover:
   • GMP regulations and guidelines
   • Proper handling of raw materials
   • Process controls and documentation
   • Sanitation and hygiene requirements
   • Labeling and packaging compliance
3. Training records should be maintained for all employees and reviewed annually to ensure compliance with the latest GMP requirements.

5.2 Documentation Control

1. Documentation is a key component of GMP compliance. All records must be completed accurately, signed, and dated by the responsible personnel.
2. Documentation to be controlled under GMP includes:
   • Batch records
   • Test results and quality control reports
   • Equipment calibration and maintenance logs
   • Employee training records
   • Material receiving and inspection logs
3. All records should be retained for the duration required by regulatory agencies, typically two years or longer.

5.3 Process Control and Monitoring

1. Production processes must be conducted according to approved Standard Operating Procedures (SOPs) to ensure consistency and quality.
2. Key process parameters (e.g., temperature, pH, mixing time) must be monitored regularly, and any deviations from specified limits must be documented and investigated.
3. Corrective actions must be taken immediately if any process parameter falls out of the established range to prevent non-compliant products from being produced.

5.4 Facility and Equipment Maintenance

1. All equipment used in the manufacturing process must be regularly maintained and calibrated according to a predefined schedule.
2. Facility sanitation and cleanliness must be maintained to prevent contamination. Cleanliness audits should be performed regularly.
3. Any equipment failure or breakdowns must be documented, and corrective actions must be implemented immediately to restore GMP compliance.

5.5 Internal Audits and Inspections

1. Regular internal audits should be conducted to assess compliance with GMP standards and identify areas for improvement.
2. Audit findings should be documented, and corrective actions must be taken to address any identified non-compliance issues.
3. Internal audits must include a review of:
   • Batch records
   • Quality control testing records
   • Production processes
   • Cleaning and sanitation records
   • Employee training records

5.6 Corrective and Preventive Actions (CAPA)

1. If any deviations from GMP standards are identified during production or audits, corrective actions must be taken to resolve the issues and prevent recurrence.
2. CAPA actions should be documented, and the effectiveness of the actions must be monitored to ensure compliance is restored.
3. The CAPA process should include:
   • Root cause analysis
   • Corrective action plan
   • Preventive actions to mitigate future risks
   • Verification of actions taken

5.7 Regulatory Compliance

1. The QA team must ensure that all GMP-related documentation and processes comply with regulatory requirements in the relevant jurisdictions.
2. Changes in regulations or updates to GMP guidelines must be communicated to all relevant departments, and necessary changes to processes and documentation should be implemented promptly.
3. Regulatory inspections should be conducted periodically, and the company must be prepared for external audits by regulatory bodies.

5.8 Continuous Improvement

1. Ongoing review and continuous improvement of GMP compliance processes are critical to maintaining high standards of product quality and safety.
2. Feedback from audits, inspections, and employee suggestions should be used to improve processes and ensure ongoing compliance with GMP guidelines.
3. The effectiveness of improvements must be evaluated to ensure that they result in tangible benefits to quality and compliance.

5.9 Documentation and Record-Keeping

1. All documents related to GMP compliance, including audit reports, training records, CAPA logs, and production records, must be retained for a minimum of two years or as required by regulatory agencies.
2. Documents must be accessible for internal and external audits, and they must be stored in a secure location to prevent unauthorized access or alteration.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Annexure-1: GMP Compliance Audit 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: GMP Compliance and Documentation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: GMP Compliance Audit Report

Audit Area	Findings	Corrective Action	Responsible Person	Timeline
Batch Documentation	Missing signatures on batch record	Ensure signatures are obtained for every batch record	Production Manager	28/01/2026

Annexure-2: CAPA Log

Corrective Action Description	Preventive Action Description	Implementation Date	Responsible Person
Retrained staff on documentation procedures	Implement a double-check system for batch records	28/01/2026	Training 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