SOP, and approving or rejecting the bulk cream based on test results.

4. Accountability

The Production Manager is accountable for ensuring that the bulk cream samples are provided in a timely manner and at the correct stage of production. The QC Manager is accountable for overseeing the sampling and testing process. The Laboratory Supervisor is accountable for reviewing test results and making decisions based on those results.

5. Procedure

5.1 Pre-Sampling Setup

1. Ensure that the production process has been completed, and the cream is ready for testing before it is transferred to filling machines.
2. Ensure that the sampling area and equipment are clean and sanitized in accordance with GMP guidelines.
3. Ensure that the sampling containers are clean, sterile, and suitable for collecting representative samples of the bulk cream.
4. Verify that the QC team has access to the necessary testing equipment (e.g., viscometer, pH meter, microbiological testing kits) to perform the required tests on the bulk cream samples.

5.2 Sampling Procedure

1. Take representative samples of the bulk cream from different parts of the batch to ensure uniformity. A minimum of three samples should be taken from different locations within the batch.
2. Ensure that each sample is of sufficient volume to allow for all required tests (e.g., viscosity, pH, microbial testing, appearance testing). The sample volume should meet the requirements as outlined in the BMR or product specifications.
3. Label the samples with the batch number, sampling date, time, and any other necessary identifiers for traceability.
4. Immediately transfer the samples to the QC laboratory for testing. Samples should not be left exposed to contamination or temperature fluctuations.

5.3 Testing Procedure

1. Viscosity Test: Measure the viscosity of the bulk cream using a calibrated viscometer. Ensure that the viscosity falls within the specified range as defined in the BMR or product specifications.
2. pH Test: Measure the pH of the bulk cream using a calibrated pH meter. Ensure that the pH is within the acceptable range as specified in the product specifications.
3. Microbial Testing: Conduct microbial testing, including tests for total viable count (TVC), yeast and mold count, and any specific microorganisms specified in the product specifications.
4. Appearance Test: Visually inspect the bulk cream for consistency, color, and texture. The cream should appear uniform, with no visible separation or clumping.
5. Ensure that all test results are recorded accurately in the Testing Log (Annexure-1) and compared against the product specifications. If any test results fall outside the acceptable range, initiate the deviation procedure as described in the Deviation Report (Annexure-2).

5.4 Handling Deviations

1. If any test results do not meet the required specifications, document the deviation in the Deviation Report (Annexure-2).
2. Investigate the cause of the deviation, which may include checking the formulation, production conditions, or equipment.
3. Implement corrective actions, which may include reworking the batch, adjusting ingredients, or modifying the production process.
4. For any critical deviations that affect product quality, halt the production and filling process until the issue is resolved.
5. Ensure that all deviations are thoroughly documented and reviewed by the QA and Laboratory Supervisors.

5.5 Post-Sampling and Testing

1. Once the testing is complete, ensure that the bulk cream meets all required specifications (e.g., viscosity, pH, microbial limits, and appearance) before it proceeds to the filling stage.
2. If the bulk cream passes all tests, approve the batch for filling and packaging, and document the approval in the Batch Production Log (Annexure-3).
3. If the bulk cream fails any tests, reject the batch or initiate the rework process as per the Batch Rework SOP (SOP/CRM/004/2025).
4. Ensure that the production team is notified of the test results and the next steps for either continuing or halting the production process.

5.6 Documentation and Record-Keeping

1. Record all sampling and testing data in the Testing Log (Annexure-1), ensuring that all information is accurate and complete.
2. Document any deviations and corrective actions in the Deviation Report (Annexure-2).
3. Maintain all sampling and testing records for a minimum of two years or as required by regulatory guidelines.
4. Ensure that all records are reviewed and signed by the Laboratory Supervisor and other relevant personnel, and stored securely for easy retrieval during audits.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• pH: Potential Hydrogen
• TVC: Total Viable Count

7. Documents

1. Annexure-1: Testing Log
2. Annexure-2: Deviation Report
3. Annexure-3: Batch Production 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: Sampling and Testing of Cream Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Testing Log

Batch Number	Test Type	Test Result	Operator	Remarks
12345	Viscosity	85 cP	John Doe	Pass

Annexure-2: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Viscosity failed	Adjusted ingredients	Jane Smith

Annexure-3: Batch Production Log

Batch Number	Production Date	Operator	Approval Status
12345	21/01/2026	John Doe	Approved

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