Standard Operating Procedure for Ensuring Uniformity of Content in Creams
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/141/2025 |
| Supersedes | SOP/CRM/141/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for ensuring the uniformity of content in cream formulations. Uniformity of content is crucial for consistent product quality, ensuring that each batch of cream contains the correct proportions of active ingredients and excipients. This SOP ensures that the distribution of components in the cream is consistent across each batch.
2. Scope
This SOP applies to all cream formulations produced at the facility. It covers the processes involved in verifying and ensuring the uniformity of active ingredients, excipients, and other critical components in cream batches, both during production and after filling.
3. Responsibilities
- Production Team: Responsible for ensuring that the cream formulation is mixed and processed uniformly during production. They are also responsible for providing representative samples for uniformity testing.
- Quality Control (QC) Team: Responsible for conducting uniformity of content testing and ensuring that the test results meet the required specifications.
- Quality Assurance (QA) Team: Responsible for reviewing and approving the results of the uniformity of content tests to ensure compliance with internal specifications and regulatory requirements.
4. Accountability
The QC Manager is accountable for ensuring that uniformity of content testing is performed according to this SOP. The Production Supervisor is responsible for ensuring that the cream formulations are uniformly mixed during production. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.
5. Procedure
5.1 Pre-Test Preparation
- Ensure that the necessary equipment for content uniformity testing is available, including a suitable laboratory balance for accurate measurements, and sampling tools for obtaining representative samples from the cream batch.
- Ensure that all necessary reagents and solvents are prepared for use in the analysis, including the correct concentration for any active ingredients or preservatives.
- Review the batch record to confirm the formulation details and the specified uniformity requirements for the active ingredients and excipients.
5.2 Sample Collection
- Collect representative samples from different parts of the batch, including the top, middle, and bottom sections of the cream container to ensure an accurate representation of the entire batch.
- Ensure that the samples are taken using proper aseptic techniques to prevent contamination and maintain uniformity.
- Label each sample with the batch number, sample ID, sampling date, and other relevant details to ensure traceability during testing.
5.3 Uniformity of Content Testing Procedure
- Weigh each sample using a calibrated laboratory balance to ensure the correct quantity is used for analysis.
- Analyze the active ingredient(s) in each sample using a validated method (e.g., HPLC, UV-Visible spectrophotometry) to quantify the concentration of the active ingredient and verify that it is within the specified limits.
- Perform testing for each sample in triplicate to ensure consistency and reliability of the results.
- Record the results of each test, including the measured concentration of the active ingredient(s) and any variations from the expected content, in the Uniformity of Content Testing Log (Annexure-1).
5.4 Interpretation of Results
- Compare the results of the uniformity of content test with the established specifications for content uniformity. The content of the active ingredient(s) should fall within the acceptable range, which is typically within ±10% of the nominal content.
- If the test results show that the content is within the specified range, mark the test as “Pass” in the Uniformity of Content Testing Log (Annexure-1) and proceed with the next stage of production or release.
- If the test results show that the content is outside the acceptable range, mark the test as “Fail.” Investigate the cause of the failure, which may include inadequate mixing, incorrect formulation, or insufficient homogenization.
5.5 Post-Test Activities
- Record all test results, including batch number, sample ID, test date, content uniformity results, and any corrective actions taken in the Uniformity of Content Testing Log (Annexure-1).
- If the uniformity of content test fails, initiate corrective actions such as adjusting the formulation, improving mixing techniques, or reprocessing the batch to ensure content uniformity. Re-test the sample after corrective actions.
- Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.
5.6 Documentation and Record-Keeping
- Ensure that all uniformity of content testing records are complete, accurate, and securely stored. This includes the Uniformity of Content Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
- Retain all records for a minimum of two years or as required by regulatory guidelines.
- Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Uniformity of Content Testing Log
- 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 for Uniformity of Content 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: Uniformity of Content Testing Log
| Batch Number | Sample ID | Test Date | Active Ingredient Content (%) | Operator |
|---|---|---|---|---|
| 12345 | S-001 | 21/01/2026 | 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 out of specification | Reprocessed and re-tested | 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 |