Key Elements Of A Good Manufacturing Practice (GMP) Audit
Good Manufacturing Practice (GMP) audit is an essential process for ensuring that products are consistently meeting the established quality standards. Regulatory authorities also require industry to apply quality risk management principles during the audit. This helps in minimizing risks involved in pharmaceutical production that cannot be eliminated through testing the final product. Below, we will explore the key elements necessary for conducting a successful GMP audit.
1. Preparation and Planning
- Define Scope: Clearly outline what areas, processes, or systems will be audited.
- Assemble Audit Team: Select auditors with appropriate expertise.
- Schedule Audit: Coordinate dates with relevant departments.
- Review Documentation: Examine previous audit reports, SOPs (Standard Operating Procedures), and regulatory guidelines.
Regular audits are mandatory to verify compliance with quality standards and regulatory requirements.
Read: High-Impact Areas for Regulatory Compliance in Pharmaceutical Manufacturing and Quality Assurance.
2. Opening Meeting
- Introduce Auditors and Auditees: Establish rapport between the auditing team and company representatives.
- Explain Objectives: Clarify the purpose and scope of the audit.
- Set Expectations: Outline how findings will be reported and used.
3. Facility Inspection
- Tour Production Areas: Inspect manufacturing / filling lines, storage facilities, quality control labs, etc.
- Example: Check cleanliness of equipment to ensure it meets hygiene standards.
- Verify Compliance with SOPs: Ensure all procedures are followed as documented. Interview users.
4. Document Review
- Key Documents to Review:
- Batch records
- Quality control records
- Training logs
- Equipment maintenance logs
- Supplier qualification documents
5. Interviews with Personnel
- Speak with employees at various levels:
- Operators on the production floor about day-to-day operations.
- Example Question: “Can you walk me through your procedure for starting up this machine?”
- Supervisors knowledge, oversight responsibilities, process, and frequency.
- Operators on the production floor about day-to-day operations.
An auditor may request additional documentation or information to verify compliance with regulations and best practices. If any deficiencies are identified, the auditor may provide recommendations for corrective action and follow-up audits may be necessary to ensure compliance.
Read – Pharmacy Auditor Questionnaire: Ensuring Compliance and Best Practices.
6. Observation of Practices
Observe real-time practices to verify adherence to GMP requirements:
- Example: Watch how raw materials are handled from supplier, at receipt station(s), and through storage to processing to ensure they meet specifications.
7. Identification of Non-Conformities
Identify areas where Procedures are not being followed (unavailable or incomplete SOPs) and practices do not conform to GMP standards:
- Categorize deficiencies / violations into minor, major, or critical based on their potential impact on product quality.
8. Closing Meeting
Discuss preliminary findings with management:
- Highlight the strengths that were observed and identified during the audit.
- Ensure non-conformities are identified clearly and objectively.
9. Reporting
Prepare a detailed report summarizing findings:
- Include both positive observations and areas where improvement is required.
- Provide actionable recommendations for each non-conformity identified.
- Discuss timelines for short-term and long-term solutions.
- Plan and discuss the need for follow-up audit.
- Encourage continuous improvement in processes, human resources, and infrastructure.
Report Format (Example):
| Section | Observation | Category | Recommendation |
|---|---|---|---|
| Document Control | Missing signatures on batch records | Major | Improve verification – implement double-check system |
10. Follow-Up Actions
Ensure corrective actions are taken promptly:
- Verify implementation through follow-up audits or reviews if necessary.
By thoroughly understanding these key elements—preparation & planning, facility inspection, document review among others— industry can conduct an effective GMP audit that ensures compliance while also driving continuous improvement.
Additional Reading
Considerations in GMP Auditing
Using Checklists in GMP Audits
Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with a focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.