Standard Operating Procedure for Self-Inspection and Internal Audit in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish the procedure for conducting self-inspections and internal audits to ensure compliance with regulatory requirements and continuous improvement of processes.

2) Scope

This SOP applies to all departments involved in the manufacturing, quality assurance, and quality control of vaginal dosage forms at [Company Name]. It covers the planning, execution, and follow-up of self-inspections and internal audits.

3) Responsibilities

Quality Assurance (QA) is responsible for planning, conducting, and documenting self-inspections and internal audits. All department heads and personnel are responsible for participating in audits and implementing corrective actions as necessary.

4) Procedure

4.1 Self-Inspection Planning

1. Develop an annual self-inspection plan based on risk assessment, regulatory requirements, and previous audit findings.
2. Define audit scope, objectives, and areas to be covered.

4.2 Self-Inspection Execution

1. Notify departments in advance of planned self-inspections.
2. Conduct inspections according to the defined checklist and procedures.
3. Document observations, findings, and non-conformances.

4.3 Internal Audit Planning

1. Develop an annual internal audit schedule based on the audit plan.
2. Select auditors and provide necessary training or qualification.

4.4 Internal Audit Execution

1. Conduct audits based on predefined checklist and audit plan.
2. Interview personnel and review documentation as part of the audit process.
3. Document audit findings, including observations and recommendations.

4.5 Corrective Actions and Follow-up

1. Assign responsibility for corrective actions to address audit findings.
2. Monitor implementation of corrective actions and verify effectiveness.
3. Close audit findings and update audit records accordingly.

5) Abbreviations, if any

QA: Quality Assurance; SOP: Standard Operating Procedure; GMP: Good Manufacturing Practice

6) Documents, if any

Self-inspection checklist, Internal audit report template, Corrective action plan template

7) Reference, if any

ICH Q10: Pharmaceutical Quality System, WHO Technical Report Series No. 996, Annex 5: Good Manufacturing Practices for Pharmaceutical Products: Main Principles

8) SOP Version

Version 1.0