for reviewing the batch records, testing results, and ensuring that any deviations from the expected quality are addressed and corrected.

4. Accountability

The QC Manager is accountable for ensuring that batch-to-batch consistency testing is performed in accordance with this SOP. The Production Supervisor is responsible for ensuring that manufacturing processes are consistently followed during production. The QA Manager is responsible for ensuring that the results of testing and manufacturing processes are reviewed and compliant with regulatory and internal standards.

5. Procedure

5.1 Pre-Manufacturing Activities

1. Ensure that the formulation and batch records are accurate and up to date. Review the batch record to ensure that all ingredients and quantities are correctly listed and that the manufacturing process follows standard operating procedures (SOPs).
2. Review the availability of raw materials to confirm that the quality and source of the ingredients remain consistent for each batch.
3. Calibrate all necessary equipment, including mixing tanks, homogenizers, and filling machines, to ensure they are functioning properly and meet specifications for consistent production.

5.2 Manufacturing Process

1. Follow the approved batch manufacturing process to ensure consistency in the mixing, blending, and homogenization of the cream formulation.
2. Monitor key parameters such as mixing time, temperature, speed, and ingredient addition to ensure they remain consistent from batch to batch.
3. Ensure that the correct quantities of ingredients are added as specified in the batch record. Use calibrated dispensing equipment to avoid deviations in the ingredient proportions.
4. Maintain proper documentation of each production step, including temperature and pressure readings, to provide traceability and support consistency checks.

5.3 Quality Control Testing

1. Perform routine quality control tests on each batch to ensure that the product meets the required specifications for consistency. These tests should include:
   • Active ingredient content
   • Viscosity
   • pH level
   • Appearance (color, texture)
   • Microbial contamination levels
2. Compare the results from each batch to the specifications to identify any potential variations in the product’s quality.
3. If the results from a batch are outside of the acceptable range, investigate the cause of the variation, which may include ingredient quality, equipment malfunction, or process deviation.

5.4 Batch-to-Batch Comparison

1. At regular intervals, perform a batch-to-batch comparison of critical parameters such as active ingredient concentration, viscosity, and pH levels. This comparison ensures that the formulation remains consistent from one batch to the next.
2. Review and document any differences observed between batches, and determine if these differences are within the acceptable limits or if corrective actions are necessary.
3. Ensure that any deviations between batches are investigated, documented in the Deviation Log (Annexure-1), and corrective actions are taken to maintain consistency.

5.5 Post-Manufacturing Activities

1. After production, complete all necessary batch records and quality control documentation, including testing results and any deviation reports.
2. Submit the batch record and testing results for review and approval by the QA team to ensure that the batch meets all specifications and complies with GMP standards.
3. If any deviations are observed, initiate corrective actions such as revising the formulation, improving manufacturing processes, or modifying equipment settings. Re-test the batch after implementing corrective actions.

5.6 Documentation and Record-Keeping

1. Ensure that all batch production records, quality control test results, and deviation reports are complete, accurate, and securely stored. This includes the Batch Manufacturing Record (Annexure-1) and the Deviation Log (Annexure-2).
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that all documentation is reviewed and approved by the Quality Assurance team to verify compliance with GMP and regulatory standards.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Batch Manufacturing Record
2. Annexure-2: Deviation 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
• Pharmacopeial Monographs on Quality Control Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Manufacturing Record

Batch Number	Sample ID	Manufacturing Date	Viscosity (cP)	pH	Active Ingredient (%)	Operator
12345	S-001	21/01/2026	2500	7.2	98.5%	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Active ingredient content below specification	Adjusted formulation, reprocessed the batch	Jane Smith

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