Formulation of Vaginal Dosage Forms Procedure
1) Purpose
The purpose of this SOP is to define the procedure for formulating vaginal dosage forms in compliance with regulatory requirements and quality standards.
2) Scope
This SOP applies to personnel involved in the formulation process of vaginal dosage forms at the pharmaceutical facility.
3) Responsibilities
The Formulation Department is responsible for following this SOP and ensuring adherence to all procedures outlined herein.
4) Procedure
4.1 Formulation Preparation
- Review the formulation recipe and gather all required raw materials from the dispensing area.
- Verify the availability and condition of equipment necessary for the formulation process.
4.2 Mixing Process
- Transfer the measured quantities of raw materials into the mixing vessel according to the formulation recipe.
- Initiate the mixing process using specified parameters (e.g., speed, time) to achieve uniform blending.
4.3 pH Adjustment and Testing
- Monitor the pH of the formulation and make necessary adjustments using approved acids or bases.
- Perform pH testing to ensure the formulation meets specified requirements.
4.4 Filtration
- Transfer the mixed formulation to a filtration unit to remove any particulate matter or impurities.
- Filter the formulation under controlled conditions to maintain sterility and integrity.
4.5 Final Inspection
- Inspect the filtered formulation visually for clarity and consistency.
- Perform additional testing or checks as per product specifications.
4.6 Documentation and Batch Record
- Complete all required documentation, including batch records and formulation log.
- Verify the accuracy and completeness of all entries before submission for review and approval.
5) Abbreviations, if any
None
6) Documents, if any
Formulation recipe, batch record, pH testing records
7) Reference, if any
USP Chapter 795: Pharmaceutical Compounding – Nonsterile Preparations, FDA Guidance for Industry: Process Validation: General Principles and Practices
8) SOP Version
Version 1.0
