What Is Pharmaceutical Audit: Learn In 3 Minutes

What Is Pharmaceutical Audit?

A pharmaceutical audit is a systematic and independent examination of pharmaceutical operations, systems, processes, or products to ensure compliance with regulatory requirements, internal standards, and industry best practices. These audits are crucial for maintaining quality, safety, and efficacy in pharmaceutical manufacturing and distribution.

Purpose of a Pharmaceutical Audit:

• Ensure compliance with regulatory bodies like the FDA (U.S.), EMA (Europe), MHRA (UK), etc.
• Verify adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other standards.
• Assess the quality management system (QMS).
• Identify risks and areas for improvement.
• Prepare for inspections by regulatory authorities.

Types of Pharmaceutical Audits:

1. Internal Audit: Conducted by the company’s own staff to monitor and improve internal processes.
2. External Audit:
   • Regulatory Audit: Carried out by government agencies (e.g., FDA inspection).
   • Customer Audit: Performed by clients or partners (e.g., a pharmaceutical company auditing a contract manufacturer).
   • Third-Party Audit: Conducted by independent organisations for certification purposes (e.g., ISO audits).

Areas Commonly Audited:

• Manufacturing processes
• Quality control laboratories
• Documentation and data integrity
• Storage and distribution
• Training and personnel qualifications
• Equipment calibration and maintenance
• Cleaning and validation procedures

Audit Outcomes:

• Compliance confirmed: No significant issues found.
• Observations: Minor issues that need correction.
• Non-conformities: Major issues requiring immediate corrective actions.
• Audit report: A formal document outlining findings, conclusions, and required actions.

Pharmaceutical Audit Checklist

1. General Information

• Date of audit
• Location/site
• Name and title of auditor(s)
• Name and title of person(s) interviewed

2. Quality Management System (QMS)

• Is there a documented Quality Policy?
• Are responsibilities and roles clearly defined?
• Is there a current organisational chart?
• Are regular internal audits conducted?
• Are Corrective and Preventive Actions (CAPAs) tracked and documented?

3. Good Manufacturing Practices (GMP) Compliance

• Are facilities and equipment maintained per GMP standards?
• Are batch production records complete and reviewed?
• Are deviations documented and investigated?
• Are there change control procedures in place?

4. Documentation and Data Integrity

• Are all records completed in real time, legible, and permanent?
• Are electronic systems validated and access-controlled?
• Are audit trails enabled for electronic records?
• Is there a record retention policy?

5. Manufacturing Processes

• Are SOPs (Standard Operating Procedures) in place and followed?
• Is the equipment cleaned and maintained?
• Are critical process parameters monitored and controlled?
• Are raw materials and APIs sourced from approved suppliers?

6. Quality Control (QC)

• Are analytical methods validated?
• Is lab equipment calibrated regularly?
• Are out-of-specification (OOS) results investigated?
• Are stability studies conducted and documented?

7. Training and Personnel

• Are employees trained for their roles?
• Is training documented and up to date?
• Is there a system for ongoing GMP training?

8. Cleaning, Sanitation, and Contamination Control

• Are cleaning SOPs in place for facility and equipment?
• Is there an environmental monitoring program?
• Are cleaning logs maintained?

9. Storage and Distribution (GDP Compliance)

• Are storage conditions (e.g. temperature, humidity) monitored?
• Are distribution records traceable?
• Are returned goods handled appropriately?

10. Validation and Qualification

• Is there a master validation plan?
• Are processes, cleaning, and equipment validated?
• Are utilities like water systems and HVAC validated?

11. Auditor Comments and Findings

• Observation #1:
• Observation #2:

12. Recommendations and Required Actions

• CAPA required? [ ] Yes [ ] No
• Responsible Person(s):
• Target Completion Date:
• Follow-up Date:

Pharmaceutical Audit – Frequently Asked Questions (FAQs)

What is the difference between an internal and external audit?

• Internal audits are conducted by a company’s own staff.
• External audits are conducted by outside parties, such as regulatory agencies, customers, or third-party certification bodies.

What areas are typically reviewed during a pharmaceutical audit?

Key areas include:

• Manufacturing processes
• Quality Control (QC)
• Documentation and data integrity
• Equipment and facility maintenance
• Personnel training
• Storage and distribution

What are the common findings in a pharmaceutical audit?

Findings may include:

• Incomplete documentation
• Deviations not properly investigated
• Poor hygiene or cleaning practices
• Gaps in employee training
• Non-compliance with SOPs

How often should pharmaceutical audits be conducted?

• Internal audits are typically conducted annually or based on risk.
• External or customer audits may occur periodically or before supplier approval.
• Regulatory audits occur as scheduled or unannounced.

What documents should be ready for an audit?

• SOPs (Standard Operating Procedures)
• Batch records
• Validation protocols and reports
• Training records
• Equipment maintenance logs
• Quality manuals and audit reports

How can a company prepare for a pharmaceutical audit?

• Conduct regular internal audits
• Keep documentation complete and up-to-date
• Train staff continuously
• Address issues proactively through CAPA
• Maintain a state of constant readiness

Related:

• Relative Response Factor (RRF) in Pharmaceutical Analysis

Further Reading

• Types of FDA Inspection