1) SOP for Quality Control Testing

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide specific procedures for conducting quality control testing of capsules using analytical instruments such as HPLC (High-Performance Liquid Chromatography), spectrophotometers, and dissolution testers.

3) Scope

This SOP applies to all quality control testing activities conducted in the pharmaceutical manufacturing facility for capsules to ensure they meet quality specifications.

4) Responsibilities

• Quality Control (QC) Department: Responsible for conducting quality control testing according to approved procedures and specifications.
• Production Department: Responsible for providing samples and supporting QC testing activities.
• Quality Assurance (QA) Department: Responsible for reviewing and approving QC testing procedures and results.
• Regulatory Affairs: Responsible for ensuring compliance with regulatory requirements related to quality control testing.

5) Procedure

1. Sample Preparation
   1. Retrieve samples of capsules from production according to sampling procedures.
   2. Prepare samples for testing, ensuring proper labeling and identification.
2. Testing Procedures
   1. Perform identification and assay testing using appropriate analytical instruments (e.g., HPLC, spectrophotometers).
   2. Conduct dissolution testing to evaluate the release of active ingredients from capsules.
   3. Follow validated methods and procedures for each type of test.
3. Data Analysis
   1. Analyze test results using specified criteria and acceptance limits.
   2. Record raw data and calculations accurately.
4. Result Reporting
   1. Prepare a test report summarizing testing procedures, results, and conclusions.
   2. Review and approve test reports by authorized personnel.
5. Documentation and Records
   1. Maintain records of all quality control testing activities, including raw data, test reports, and instrument calibration logs.
   2. Archive records according to company procedures and regulatory requirements.
   3. Review and approve testing records periodically.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography
• QC: Quality Control
• QA: Quality Assurance

7) Documents, if any

• Quality Control Testing Procedures
• Test Reports
• Instrument Calibration Logs

8) Reference, if any

• Pharmacopeial monographs (e.g., USP, EP)
• ICH guidelines for validation of analytical procedures
• Company-specific quality control procedures

9) SOP Version

Version 1.0