Raw Material Testing and Release for Vaginal Dosage Forms

1) Purpose

The purpose of this SOP is to outline the procedure for testing and releasing raw materials used in the manufacturing of vaginal dosage forms, ensuring they meet the required quality standards before use in production.

2) Scope

This SOP applies to all raw materials received for the manufacturing of vaginal dosage forms at the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) and Quality Assurance (QA) departments are responsible for implementing and adhering to this SOP.

4) Procedure

4.1 Sample Receipt and Logging

1. Upon receiving raw material samples, log them into the laboratory information management system (LIMS) with details such as material name, batch/lot number, date of receipt, and supplier.
2. Assign a unique identification number to each sample for traceability.

4.2 Sample Testing

1. Refer to the material specification sheet to determine the required tests and acceptance criteria.
2. Perform the following tests as applicable to the raw material:
   1. Identity Test
   2. Purity Test
   3. Potency Test
   4. Microbial Limits Test
   5. Moisture Content Test
   6. Other specified tests
3. Use validated analytical methods and calibrated equipment for testing.
4. Document all test results in the laboratory notebook or electronic system.

4.3 Review of Test Results

1. QA personnel will review the test results against the acceptance criteria specified in the material specification sheet.
2. Investigate any out-of-specification (OOS) results according to the OOS procedure.

4.4 Approval or Rejection of Raw Materials

1. If the test results meet the acceptance criteria, approve the raw material for use in production.
2. Update the inventory management system to reflect the approved status of the material.
3. Label the approved raw material containers with an “Approved” status tag, including the approval date and QA personnel’s signature.
4. If the test results do not meet the acceptance criteria, reject the raw material.
5. Update the inventory management system to reflect the rejected status of the material.
6. Label the rejected raw material containers with a “Rejected” status tag, including the rejection date and QA personnel’s signature.
7. Store rejected materials separately from approved materials to prevent accidental use.

4.5 Documentation and Record Keeping

1. Maintain detailed records of all test results, approvals, and rejections in the laboratory notebook or electronic system.
2. Ensure records are reviewed regularly and retained according to regulatory requirements.

4.6 Training

1. Provide training to personnel involved in the testing and release of raw materials on the procedures and documentation requirements outlined in this SOP.
2. Document all training sessions and ensure all relevant staff are trained.

5) Abbreviations, if any

QC – Quality Control
QA – Quality Assurance
LIMS – Laboratory Information Management System
OOS – Out of Specification

6) Documents, if any

Material specification sheets, test results, laboratory notebooks, electronic records, inventory records

7) Reference, if any

FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations, ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0