Getting Ready

Preparing for a Good Manufacturing Practice (GMP) audit requires a structured approach to ensure compliance with regulatory requirements and industry best practices. Here’s a step-by-step guide to help you prepare:

1. Understand the Scope

  • Determine the type of audit and who the auditors are. i.e. internal, external, or regulatory (e.g., FDA, EMA, WHO).
  • Identify the specific GMP standards applicable to your facility 
  • Review previous audit findings to address any recurring issues.

2. Assemble a Preparation Team

  • Assign roles and responsibilities to key personnel from Quality Assurance (QA), Manufacturing, Engineering, and other departments.
  • Designate a point of contact to coordinate the audit process and communicate with auditors.
  • Conduct a pre-audit meeting to align expectations.

3. Conduct a Gap Analysis

  • Perform an internal audit to identify non-conformities before the official audit.
  • Use a GMP compliance checklist to ensure all areas meet regulatory standards.
  • Document findings and implement corrective actions.

4. Review Documentation and Records

  • Ensure Standard Operating Procedures (SOPs) are up to date and reflect current practices.
  • Verify batch records, deviation reports, training records, validation documents, and CAPAs (Corrective and Preventive Actions).
  • Organize logbooks and maintenance records for easy retrieval.

5. Train Employees

  • Conduct GMP refresher training for all staff to reinforce compliance.
  • Practice mock interviews to ensure employees confidently answer auditor questions.

6. Prepare the Facility

  • Perform a walkthrough inspection of your facility. 
  • Identify potential issues that may be flagged or prompt further investigation into your operations.

7. Develop an Audit-Day Strategy

  • Assign a designated escort to guide auditors through the facility.
  • Set up a document review area where auditors can inspect records comfortably.
  • Encourage employees to provide concise and factual responses without volunteering unnecessary information.

What Happens on Audit Day? 

Here’s a breakdown of what typically happens on the GMP audit day: 

1. Opening Meeting

  • The audit begins with an introductory meeting between auditors and key facility personnel (e.g., Quality Assurance, Manufacturing, Regulatory Affairs).
  • The auditor explains the scope, objectives, and methodology of the audit.
  • The facility may give an overview presentation about its operations and quality systems.

2. Facility Walkthrough (Plant Tour)

  • Auditors inspect production areas, warehouses, laboratories, and other key sites.
  • They observe cleanliness, organization, and adherence to SOPs (Standard Operating Procedures).
  • Equipment and facility conditions, such as maintenance records and calibration status, are examined.
  • Auditors may check for potential cross-contamination risks, pest control measures, and employee hygiene compliance.

3. Documentation Review

Auditors examine records to ensure compliance with GMP standards. Key documents include:

  • Batch manufacturing records (BMRs) – Ensure consistency in production.
  • Standard Operating Procedures (SOPs) – Must be approved, followed, and periodically reviewed.
  • Training records – Verify employees are trained on GMP and job-specific procedures.
  • Quality control and lab records – Check analytical test results, raw material approvals, and release procedures.
  • Change control, deviations, and CAPAs (Corrective and Preventive Actions) – Ensure non-conformities are documented and addressed.

4. Employee Interviews

  • Auditors may question employees about their roles and responsibilities.
  • They assess whether staff understands GMP principles, follows SOPs, and can explain their work processes clearly.
  • Auditors may randomly select employees to discuss how they handle deviations, record-keeping, and hygiene procedures.

5. Data Integrity and Traceability Checks

  • Auditors scrutinize electronic and paper records for inconsistencies, alterations, or missing data.
  • They verify audit trails, timestamps, and compliance with ALCOA+ principles (E.g., Attribution, Legitimacy, Contemporaneity, Originality, and Accuracy).
  • Traceability is tested by tracking raw materials to finished products (e.g., lot number tracking, supplier verification).

6. Review of Compliance to Regulatory Guidelines

  • Auditors compare the company’s processes with GMP regulations (e.g., FDA 21 CFR Part 211, EU GMP, WHO GMP).
  • They assess the firm’s quality culture, including how management ensures compliance and continuous improvement.

7. Closing Meeting & Audit Findings Presentation

  • Auditors summarize observations, deficiencies, and compliance strengths.
  • They classify findings into categories such as:
    • Critical – Major violations posing health risks or regulatory action.
    • Major – Significant non-conformities requiring prompt correction.
    • Minor – Issues needing improvement but not immediate risks.
  • If any findings are noted, the facility may be required to submit a Corrective and Preventive Action (CAPA) plan within a set timeframe.

Tactics for a Successful Audit 

  1. Be ready at All Times
  2. Organize Documentation for Easy Access
  3. Train and Empower Employees
  4. Conduct a Pre-Audit Walkthrough
  5. Assign a document retrieval team to provide records quickly.
  6. Have subject matter experts (SMEs) available to answer auditor-specific questions.
  7. Manage Auditor Interactions Professionally
  8. Ensure records comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more).
  9. Keep audit trails intact for electronic and manual records.
  10. If an auditor identifies an issue, acknowledge it professionally and explain your action plan.
  11. Avoid arguing or being defensive—show commitment to continuous improvement.
  12. Conduct a Strong Closing Meeting, recapping findings and action items. 
  13. If non-conformities are found, outline your corrective action plan and expected timelines.
  14. Follow Up and Implement Corrective Actions
    • Address audit findings promptly and document corrective actions.
    • If required, submit a CAPA (Corrective and Preventive Action) report within the auditor’s deadline.
    • Monitor compliance improvements through ongoing internal audits and reviews.