Standard Operating Procedure for Conducting Internal Audits in Creams Production
1) Purpose
The purpose of this SOP is to establish procedures for conducting internal audits of creams production processes to ensure compliance with regulatory requirements, Good Manufacturing Practices (GMP), and company standards.
2) Scope
This SOP applies to all personnel involved in the internal audit process within the creams production facility. It covers the planning, execution, reporting, and follow-up of internal audits.
3) Responsibilities
It is the responsibility of the Quality Assurance (QA) department to plan, conduct, and report on internal audits. Production and quality control personnel are responsible for providing necessary documentation and facilitating audit activities.
4) Procedure
4.1 Audit Planning
4.1.1 Determine the scope and objectives of the internal audit, focusing on creams production processes, equipment, facilities, and documentation.
4.1.2 Identify audit criteria, including relevant regulations, GMP guidelines, company policies, and procedures.
4.1.3 Develop an audit schedule and notify relevant departments and personnel about the upcoming audit.
4.2 Audit Execution
4.2.1 Conduct an opening meeting with audit team members and auditees to discuss the audit objectives, scope, and expectations.
4.2.2 Review documents and records related to creams production, including batch records, SOPs, validation reports, and training records.
4.2.3 Perform on-site inspections of production areas, equipment, and
4.2.4 Interview personnel involved in creams production to assess their understanding of procedures and adherence to GMP.
4.3 Audit Reporting
4.3.1 Document audit findings, observations, and non-conformances identified during the audit process.
4.3.2 Classify findings based on severity and impact on product quality and regulatory compliance.
4.3.3 Prepare an audit report summarizing findings, including strengths, areas for improvement, and recommendations for corrective actions.
4.4 Corrective Actions and Follow-Up
4.4.1 Communicate audit findings to relevant departments and management for review and corrective action planning.
4.4.2 Track implementation of corrective actions and verify effectiveness through follow-up audits or inspections.
4.4.3 Close out audit findings once corrective actions have been implemented and verified.
4.5 Audit Documentation and Records
4.5.1 Maintain comprehensive records of audit planning, execution, findings, and follow-up actions.
4.5.2 Archive audit reports and related documentation for future reference, regulatory inspections, and management review.
5) Abbreviations, if any
QA: Quality Assurance
GMP: Good Manufacturing Practices
SOP: Standard Operating Procedure
6) Documents, if any
Audit Schedule
Audit Checklist
Audit Report
Corrective Action Plans
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0