SOP for Product Quality Review

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.

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