Standard Operating Procedure for Inspection of Final Cream Batch Quality

Department	Creams
SOP No.	SOP/CRM/066/2025
Supersedes	SOP/CRM/066/2022
Page No.	Page 1 of 6
Issue Date	11/01/2026
Effective Date	16/01/2026
Review Date	11/01/2027

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures for inspecting the final cream batch quality before it is released for packaging and distribution. Inspection of the final cream batch is crucial to ensure that the product meets the required quality standards for consistency, texture, appearance, and safety. This SOP ensures that the inspection is conducted systematically and in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to the final inspection of all cream batches produced in the Creams Department. It includes the procedures for evaluating physical characteristics, testing for sensory attributes, and documenting the results to confirm that the batch complies with the product specifications and quality standards.

3. Responsibilities

• Production Team: Responsible for preparing the final batch for inspection, ensuring that the batch is properly mixed and cooled, and presenting it for inspection at the designated inspection station.
• Quality Control (QC): Responsible for performing the final inspection, including physical and sensory testing, and documenting the results. QC must ensure that the batch meets the required specifications before release.
• Quality Assurance (QA): Ensures compliance with GMP guidelines, reviewing inspection records and approving the batch for release to the next stage (e.g., packaging or storage).
• Maintenance Team: Responsible for ensuring that all equipment used in the inspection process (e.g., measuring devices, testing instruments) is calibrated and in good working condition.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that the inspection process is carried out according to this SOP. The QA Manager is accountable for reviewing the inspection records, approving the batch for release, and ensuring compliance with regulatory and quality standards.

5. Procedure

5.1 Pre-Inspection Preparation

1. Ensure that the cream batch has completed all previous manufacturing steps, including mixing, homogenization, and cooling, and that it is ready for inspection.
2. Verify that all required equipment for the inspection, such as sensory evaluation tools, measuring instruments, and sample containers, are available and functioning correctly.
3. Ensure that the inspection area is clean and free from any contaminants to prevent cross-contamination during the inspection process.
4. Prepare and review the product specifications for the batch, including desired characteristics such as viscosity, color, odor, and pH.

5.2 Physical Inspection of Final Cream Batch

1. Visually inspect the cream for any inconsistencies in color, texture, and appearance. Ensure that the cream is uniform and free from any visible contaminants or foreign particles.
2. Check the consistency of the cream by performing a spreadability test. The cream should be smooth, with no lumps or separation of phases.
3. Measure the viscosity of the cream using a viscometer, ensuring that the viscosity falls within the specified range as per the formulation.
4. If the cream shows any deviation from the desired appearance or consistency, document the deviation and initiate corrective actions as necessary.

5.3 Sensory Evaluation

1. Conduct a sensory evaluation of the cream to assess its odor, texture, and spreadability. This can be done by trained sensory panelists who are familiar with the product specifications.
2. Evaluate the odor to ensure that it is pleasant and free from any off-putting or rancid smells. The fragrance should align with the product’s intended scent.
3. Assess the spreadability of the cream by applying a small amount to a test surface and ensuring that it spreads evenly without excessive resistance or separation.
4. Record the results of the sensory evaluation in the Sensory Evaluation Log (Annexure-1), noting any issues or deviations from the expected product characteristics.

5.4 pH Testing

1. Measure the pH of the final cream batch using a calibrated pH meter. The pH should fall within the acceptable range for the cream formulation (usually between 4.5 and 7.5).
2. If the pH of the cream is outside the acceptable range, document the deviation and take corrective actions such as adjusting the formulation or conducting additional tests.
3. Record the pH values in the pH Testing Log (Annexure-2).

5.5 Microbial Testing

1. Perform microbial testing on the final cream batch to ensure that it is free from harmful microorganisms. This can include tests for total bacterial count, yeast and mold, and specific pathogens as required by the product specifications.
2. If microbial contamination is detected, immediately isolate the batch and initiate the corrective actions outlined in the deviation handling procedure.
3. Document the results of microbial tests in the Microbial Testing Log (Annexure-3).

5.6 Documentation

1. Complete the Final Batch Inspection Log (Annexure-4) for each batch, including all physical, sensory, and analytical test results, as well as any deviations and corrective actions taken.
2. Review the inspection records for completeness and accuracy. Ensure that all test results are within the acceptable limits before the batch proceeds to packaging.
3. All inspection records must be signed by the QC personnel performing the inspection and reviewed by the QA team.

5.7 Final Approval

1. The QA team must review all inspection results and ensure that the cream batch meets all quality specifications. If the batch passes inspection, it will be approved for packaging and distribution.
2. If the batch does not meet the required specifications, the QA team must initiate a deviation investigation and decide whether to reject the batch, rework it, or take other corrective actions.

6. Abbreviations

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

7. Documents

1. Final Batch Inspection Log (Annexure-4)
2. Sensory Evaluation Log (Annexure-1)
3. pH Testing Log (Annexure-2)
4. Microbial Testing Log (Annexure-3)
5. Deviation Report Form (Annexure-5)

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 Guidelines for Cosmetics Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sensory Evaluation Log

Batch Number	Time of Evaluation	Odor	Texture	Spreadability	Evaluator	Comments
12345	09:00 AM	Pleasant	Smooth	Good	John Doe	No issues

Annexure-2: pH Testing Log

Batch Number	pH Reading	Operator	Time of Measurement	Comments
12345	6.2	Jane Smith	10:00 AM	No issues

Annexure-3: Microbial Testing Log

Batch Number	Test Type	Result	Operator	Comments
12345	Total Bacterial Count	Pass	John Doe	No contamination

Annexure-4: Final Batch Inspection Log

Batch Number	Inspection Date	Operator	Physical Inspection	Sensory Evaluation	pH Test	Microbial Test	Approval
12345	11/01/2026	Jane Smith	Pass	Pass	6.2	Pass	Approved

Annexure-5: Deviation Report Form

Deviation Description	Time	Batch Number	Operator	Immediate Action
Off-odor detected	09:30 AM	12345	John Doe	Investigated, confirmed acceptable

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