SOP for Finished Product Testing for Creams

SOP for Finished Product Testing for Creams

Standard Operating Procedure for Finished Product Testing for Creams

1) Purpose

The purpose of this SOP is to define procedures for conducting finished product testing on creams. This ensures that creams meet specified quality standards before release for distribution and use.

2) Scope

This SOP applies to the Quality Control Department and personnel responsible for conducting finished product testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.

3) Responsibilities

The Quality Control Manager is responsible for overseeing finished product testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.

4) Procedure

4.1 Sampling

4.1.1 Select representative samples of finished creams from the batch for testing.

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4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.

4.1.3 Label each sample with batch information and identification numbers.

4.2 Visual Inspection

4.2.1 Conduct visual inspection of samples for any signs of contamination, discoloration, or physical defects.

4.2.2 Record observations of visual inspection findings.

4.3 Identification and Documentation

4.3.1 Verify the identity of each sample against batch records and labeling.

4.3.2 Document sample information including batch number, sampling date, and storage conditions.

4.4 Physical Tests

4.4.1 Perform physical tests such as viscosity testing, pH testing, and appearance evaluation according to specified methods.

4.4.2

Record test results and compare against acceptance criteria.

4.5 Chemical Tests

4.5.1 Perform chemical tests including assay of active ingredients and preservative content testing as per approved methods.

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4.5.2 Record test results and compare against acceptance criteria.

4.6 Microbiological Tests

4.6.1 Conduct microbiological tests including microbial limits testing and sterility testing where applicable.

4.6.2 Record test results and compare against acceptance criteria.

4.7 Stability Testing

4.7.1 Perform stability testing on samples to ensure product stability over defined periods and under specified conditions.

4.7.2 Record stability test results and compare against acceptance criteria.

4.8 Additional Tests

4.8.1 Perform additional tests as required by regulatory guidelines or specific customer requirements.

4.8.2 Record test results and compare against acceptance criteria.

4.9 Acceptance Criteria

4.9.1 Establish acceptance criteria based on regulatory requirements, product specifications, and compendial standards.

4.9.2 Evaluate test results against acceptance criteria to determine pass or fail status for each sample.

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4.9.3 Document and justify acceptance or rejection decisions based on test results.

4.10 Documentation and Reporting

4.10.1 Document all finished product testing activities, including sample preparation, testing methods, procedures, results, and observations.

4.10.2 Prepare finished product testing reports summarizing test conditions, results, conclusions, and recommendations.

4.10.3 Obtain approval from Quality Control Management for finished product testing reports.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

USP: United States Pharmacopeia

6) Documents, if any

Product Batch Records

Finished Product Testing Protocols

Finished Product Testing Reports

Non-Conforming Material Reports

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

USP : General chapters related to quality control and finished product testing of pharmaceutical products

8) SOP Version

Version 1.0

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