Standard Operating Procedure for Self-Inspection and Internal Audits in Otic Manufacturing Unit
1) Purpose
To establish a framework for conducting self-inspections and internal audits within the Otic manufacturing unit to ensure compliance with Good Manufacturing Practices (GMP) and internal quality standards.
2) Scope
This SOP applies to all departments and personnel involved in the Otic manufacturing unit responsible for conducting and participating in self-inspections and internal audits.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for planning, coordinating, and conducting internal audits.
Department Heads: Responsible for ensuring departmental compliance and participation in audits.
Management: Responsible for reviewing audit findings and implementing corrective actions.
All Personnel: Responsible for cooperating with auditors and addressing audit findings in their respective areas.
4) Procedure
4.1 Self-Inspection Planning
4.1.1 Annual Schedule
4.1.1.1 Develop an annual self-inspection schedule based on risk assessment and regulatory requirements.
4.1.1.2 Obtain approval for the self-inspection schedule from management.
4.1.2 Inspection Plan
4.1.2.1 Define objectives, scope, and criteria for self-inspections.
4.1.2.2 Prepare checklists and inspection protocols for each area to be inspected.
4.2 Conducting Self-Inspections
4.2.1 Notification
4.2.1.1 Notify relevant departments
4.2.1.2 Coordinate with department heads to facilitate access and cooperation during inspections.
4.2.2 Inspection Execution
4.2.2.1 Follow established checklists and protocols to conduct inspections.
4.2.2.2 Document observations, findings, and areas of non-compliance.
4.3 Internal Audit Planning
4.3.1 Audit Schedule
4.3.1.1 Develop an annual audit schedule covering all critical areas and processes.
4.3.1.2 Ensure audits are conducted at planned intervals and in accordance with GMP requirements.
4.3.2 Audit Preparation
4.3.2.1 Define audit objectives, scope, and criteria based on risk assessment.
4.3.2.2 Select audit team members and assign audit responsibilities.
4.4 Conducting Internal Audits
4.4.1 Opening Meeting
4.4.1.1 Conduct an opening meeting to introduce the audit team, explain audit objectives, and review the audit plan.
4.4.1.2 Obtain necessary documents and records for review.
4.4.2 Audit Execution
4.4.2.1 Perform audits using checklists, interviewing personnel, and reviewing documents.
4.4.2.2 Record audit findings, observations, and opportunities for improvement.
4.5 Reporting and Follow-Up
4.5.1 Draft Audit Report
4.5.1.1 Prepare a comprehensive audit report summarizing findings, observations, and corrective actions.
4.5.1.2 Include recommendations for improvement and assign responsibility for corrective actions.
4.5.2 Management Review
4.5.2.1 Review audit reports with management and relevant stakeholders.
4.5.2.2 Obtain approval for corrective actions and timelines for implementation.
5) Abbreviations, if any
SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
6) Documents, if any
Self-inspection checklists
Audit reports and findings
Corrective action records
7) Reference, if any
GMP guidelines for pharmaceutical manufacturing
8) SOP Version
Version 1.0