Standard Operating Procedure for Managing Deviations and Implementing Corrective Actions in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to outline the procedures for managing deviations from established procedures and implementing timely corrective actions to prevent recurrence.

2) Scope

This SOP applies to all deviations identified during the manufacturing, testing, packaging, and distribution of vaginal dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing the deviation management process. Production and Quality Control (QC) departments are responsible for documenting deviations and proposing corrective actions.

4) Procedure

4.1 Identification of Deviation

1. Identify and document any deviation from established procedures, including process deviations, equipment failures, environmental deviations, or human errors.
2. Record the deviation details, including date, time, location, personnel involved, and description of the deviation.

4.2 Evaluation and Assessment

1. Assess the impact of the deviation on product quality, safety, efficacy, and regulatory compliance.
2. Classify the deviation based on severity and potential risk to product quality.

4.3 Investigation

1. Initiate a thorough investigation to determine the root cause of the deviation.
2. Formulate a detailed investigation report, including findings, root cause analysis, and proposed corrective actions.

4.4 Corrective Actions

1. Develop and implement corrective actions to prevent recurrence of the deviation.
2. Assign responsibilities and timelines for implementing corrective actions.

4.5 Verification and Effectiveness Check

1. Verify the effectiveness of implemented corrective actions through follow-up inspections, testing, or other verification activities.
2. Document the results of the verification process and ensure closure of the deviation.

4.6 Documentation and Reporting

1. Document all steps taken during deviation management, including investigation, corrective actions, and verification.
2. Report the deviation, investigation findings, and corrective actions to relevant departments and management.

5) Abbreviations, if any

QA: Quality Assurance
QC: Quality Control

6) Documents, if any

Deviation report, investigation report, corrective action plan

7) Reference, if any

ICH Q9: Quality Risk Management, WHO Technical Report Series No. 996, Annex 5: WHO guidelines on good manufacturing practices for pharmaceutical products

8) SOP Version

Version 1.0