also ensures that methods are suitable for their intended use.

Quality Assurance (QA) Team: Responsible for reviewing and approving the results of the method validation process to ensure that the methods meet internal and regulatory standards.

4. Accountability

The QC Manager is accountable for ensuring that all analytical methods are validated in accordance with this SOP. The Production Supervisor is responsible for ensuring that the formulations are available for testing during the validation process. The QA Manager ensures that the results of the validation process are reviewed and the methods are approved for use in routine testing.

5. Procedure

5.1 Pre-Validation Preparation

1. Ensure that the necessary equipment for method validation is available, including calibrated laboratory instruments (e.g., spectrophotometers, pH meters, viscometers) and analytical reagents.
2. Review the method to be validated, including its intended use, specifications, and any applicable regulatory guidelines (e.g., USP, EP, ICH).
3. Ensure that a representative sample of the cream formulation is prepared for testing according to the validation protocol.
4. Prepare the validation protocol, including objectives, parameters to be validated (e.g., specificity, precision, accuracy, linearity, range, robustness), and the criteria for acceptance.

5.2 Method Validation Testing

1. Conduct method validation by testing the cream samples under various conditions to assess the reliability of the method. This may include performing tests at different concentrations, times, or temperatures.
2. Validate parameters such as:
   • Specificity: Ensure that the method can accurately measure the active ingredient or other critical attributes without interference from other components in the formulation.
   • Precision: Test the method’s repeatability and reproducibility by performing multiple tests on the same sample under the same conditions.
   • Accuracy: Assess the method’s accuracy by comparing results obtained from the validated method with results from a reference or known method.
   • Linearity: Test the method’s ability to produce results that are directly proportional to the concentration of the sample within a specified range.
   • Range: Establish the concentration range within which the method is applicable and produces accurate and precise results.
   • Robustness: Assess the method’s ability to withstand small variations in experimental conditions (e.g., temperature, pH) without affecting the results.
3. Record all test results, including any observations, deviations, or issues encountered during the validation process, in the Method Validation Log (Annexure-1).

5.3 Data Interpretation

1. Analyze the results of the method validation to determine if the method meets the predefined acceptance criteria for each validated parameter.
2. If the results meet the acceptance criteria, mark the method as validated and suitable for routine use in cream testing.
3. If the results do not meet the criteria, investigate the cause of failure, make necessary adjustments to the method or process, and re-validate the method.

5.4 Post-Validation Activities

1. Record all validation results, including pass/fail determinations, in the Method Validation Log (Annexure-1) and prepare a summary report.
2. Submit the validation report for review and approval by the QA team to ensure compliance with regulatory and internal standards.
3. If necessary, update the standard operating procedures (SOPs) and method protocols to incorporate the validated method.

5.5 Documentation and Record-Keeping

1. Ensure that all method validation records are complete, accurate, and securely stored. This includes the Method Validation Log (Annexure-1) and the Deviation Log (Annexure-2) for failed validation attempts.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. 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
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Annexure-1: Method Validation Log
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 for Analytical Method Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Method Validation Log

Batch Number	Sample ID	Test Date	Test Parameters	Acceptance Criteria	Test Result	Operator
12345	S-001	21/01/2026	pH, Viscosity, Active Ingredient	pH: 6.5-7.5, Viscosity: 2000-2500 cP, Active Ingredient: 98-102%	Pass	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Viscosity out of specification	Reformulated the batch, re-validated method	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