Standard Operating Procedure for Product Quality Review in Vaginal Dosage Form Manufacturing
1) Purpose
The purpose of this SOP is to establish a procedure for conducting periodic product quality reviews to assess the overall quality status of vaginal dosage forms.
2) Scope
This SOP applies to the Quality Assurance (QA) Department responsible for conducting product quality reviews for all marketed vaginal dosage forms.
3) Responsibilities
The QA Department is responsible for initiating, conducting, and documenting product quality reviews. The Regulatory Affairs Department is responsible for ensuring compliance with regulatory requirements related to product quality reviews.
4) Procedure
4.1 Initiation of Product Quality Review
- At predefined intervals, QA initiates a product quality review based on a predefined schedule.
4.2 Data Collection
- QA collects relevant data including batch records, complaints, deviations, stability data, and any other relevant information.
- Ensure that data collected covers all aspects of product quality including manufacturing, packaging, testing, and distribution.
4.3 Data Analysis
- Analyze collected data to identify trends, recurring issues, and deviations from established quality standards.
- Assess the impact of any identified issues on product quality and patient safety.
4.4 Review Meeting
- Conduct a review meeting with relevant departments to discuss findings from the data analysis.
- Identify root causes of any quality issues and determine corrective and preventive actions (CAPAs) where necessary.
4.5 Report Preparation
- Prepare a comprehensive product quality review report summarizing findings, conclusions, and recommendations.
- Include a review of compliance with regulatory requirements and GMP guidelines.
5) Abbreviations, if any
QA: Quality Assurance; GMP: Good Manufacturing Practice; CAPA: Corrective and Preventive Action
6) Documents, if any
Product quality review report template
7) Reference, if any
ICH Q10: Pharmaceutical Quality System, WHO Technical Report Series No. 996, Annex 5: WHO good manufacturing practices for pharmaceutical products: main principles
8) SOP Version
Version 1.0
