Standard Operating Procedure for Physical Appearance Testing of Creams
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/125/2025 |
| Supersedes | SOP/CRM/125/2022 |
| 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 establish the procedure for testing the physical appearance of cream formulations. Physical appearance is a critical parameter that affects product aesthetics and customer satisfaction. This SOP ensures that cream products meet the desired standards for color, texture, and consistency before they are released for packaging and distribution.
2. Scope
This SOP applies to all cream formulations produced in the facility. It includes procedures for visual inspection, testing the texture, color, and consistency of cream formulations at different stages of production, including after mixing, during stability testing, and prior to packaging.
3. Responsibilities
- Production Team: Responsible for collecting samples at specified stages of production (e.g., post-mixing, pre-filling) for physical appearance testing and ensuring that samples are delivered to the QC laboratory.
- Quality Control (QC) Team: Responsible for performing the physical appearance tests and ensuring that the cream formulations meet the defined quality standards for color, texture, and consistency.
- Quality Assurance (QA) Team: Responsible for reviewing test results, ensuring compliance with GMP standards, and approving the final product for packaging and distribution.
4. Accountability
The QC Manager is accountable for ensuring that physical appearance testing is carried out accurately and according to the defined procedure. The Production Supervisor is responsible for ensuring proper sampling at the appropriate stages. The QA Manager ensures overall compliance with GMP and regulatory requirements.
5. Procedure
5.1 Pre-Test Preparation
- Ensure that all necessary equipment and supplies are available for physical appearance testing, including clean sample containers, observation area, and lighting.
- Verify that the cream formulations to be tested have been appropriately mixed and stored under the conditions specified in the batch record.
- Review the batch record to confirm the sampling points for physical appearance testing, ensuring that the samples are taken at the correct stage of production (e.g., after mixing, prior to packaging).
- Ensure that the testing environment is clean, well-lit, and free from contamination to allow for accurate visual inspection.
5.2 Sample Collection
- Collect a representative sample from the cream formulation at the designated stage of production (e.g., post-mixing or pre-filling).
- Ensure that the sample is mixed thoroughly before collection to avoid any inconsistencies in texture or appearance.
- Label the sample with the batch number, sampling date, and sampling point (e.g., post-mixing, pre-filling) for proper identification during testing.
- If necessary, store the sample under appropriate conditions (e.g., room temperature or refrigerated) until the test is conducted to maintain product integrity.
5.3 Physical Appearance Testing Procedure
- Place the sample on a clean, flat surface in a well-lit area. Ensure that the lighting conditions allow for accurate visual inspection of the product.
- Inspect the cream formulation for the following parameters:
- Color: Check the consistency of color, ensuring it matches the desired specification for the product.
- Texture: Assess the texture by gently rubbing the cream between fingers. It should be smooth and free from lumps or irregularities.
- Consistency: Assess the cream’s consistency by observing its flow behavior. It should not be too thick or too runny unless the product specifications state otherwise.
- Clarity: If applicable, ensure that the cream is clear and free of any particulate matter or separation.
- Other Defects: Check for defects such as bubbles, uneven texture, or discoloration that may indicate poor formulation or contamination.
- Record all findings in the Physical Appearance Testing Log (Annexure-1), noting any deviations from the expected appearance.
5.4 Interpretation of Results
- Compare the observed physical appearance with the established product specifications. The cream should meet the defined standards for color, texture, consistency, and clarity.
- If the sample passes the physical appearance test, mark the test as “Pass” in the Physical Appearance Testing Log (Annexure-1).
- If the sample fails the test (e.g., off-color, lumps, incorrect texture), mark the test as “Fail” and document the cause of the failure. Initiate an investigation to determine the cause of the deviation, which may include formulation issues, contamination, or improper mixing.
5.5 Post-Test Activities
- If the sample passes the physical appearance test, proceed with the next stage of production (e.g., packaging or labeling).
- If the sample fails the test, investigate the cause of the failure, perform corrective actions, and re-test the cream formulation until it meets the specifications.
- Document all test results, including the batch number, sample ID, test results, and corrective actions taken, in the Physical Appearance Testing Log (Annexure-1).
- Review all testing records and ensure they are complete and accurate. Submit the test records for review and approval by the QA team.
5.6 Documentation and Record-Keeping
- Ensure that all physical appearance testing records are complete and accurately filled out, including the Physical Appearance Testing Log (Annexure-1) and any deviation logs for failed tests (Annexure-2).
- Retain all records for a minimum of two years or as per regulatory requirements.
- Ensure that records are reviewed by the Quality Assurance team to verify compliance with GMP standards and regulatory guidelines.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Physical Appearance 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 Appearance 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: Physical Appearance Testing Log
| Batch Number | Sample ID | Sampling Date | Color | Texture | Consistency | Operator |
|---|---|---|---|---|---|---|
| 12345 | S-001 | 21/01/2026 | White | Smooth | Medium | John Doe |
Annexure-2: Deviation Log
| Deviation Date | Batch Number | Deviation Description | Corrective Action Taken | Operator |
|---|---|---|---|---|
| 21/01/2026 | 12345 | Off-color cream | Adjusted formulation | 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 |