Procedure for Manufacturing Vaginal Suppositories
1) Purpose
The purpose of this SOP is to outline the procedures for the manufacturing of vaginal suppositories to ensure consistency, quality, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the manufacturing process of vaginal suppositories in the facility.
3) Responsibilities
It is the responsibility of production operators, quality assurance staff, and supervisors to adhere to this SOP for the effective production of vaginal suppositories.
4) Procedure
4.1 Formulation Preparation
- Verify the availability and integrity of raw materials required for suppository formulation.
- Weigh and measure each ingredient according to the formulation specifications.
- Mix the ingredients thoroughly in the appropriate equipment to achieve a homogenous blend.
4.2 Suppository Molding
- Prepare suppository molds and ensure they are clean and sanitized.
- Pour the molten suppository mixture into the molds under controlled conditions.
- Allow the suppositories to cool and solidify in the molds.
4.3 Packaging
- Remove the solidified suppositories from the molds.
- Inspect each suppository for quality attributes such as shape, size, and uniformity.
- Package the suppositories in appropriate containers, ensuring proper labeling and batch coding.
4.4 Cleaning and Sanitization
- Clean all equipment and work areas thoroughly after each production batch.
- Sanitize molds, equipment, and packaging materials according to approved procedures.
5) Abbreviations, if any
N/A
6) Documents, if any
Formulation record, Batch production record, Cleaning log
7) Reference, if any
GMP guidelines, Regulatory requirements for suppository manufacturing
8) SOP Version
Version 1.0
