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GMP Audit Checklist for Pharmaceutical | WHO Guideline (Part-1)

As per WHO recent guideline for GMP audit following information to be updated - 


  • Full address of the company
  • Inspection type : routine/ internal/ external/ follow-up etc.
  • Facility/Department bieng inspected
  • Types and list of product 
  • Senior persons profile: name, position, department, qualification etc.
  • Floor plans of the facility: airflow patterns, differential pressure, cleanroom classification, personnel and visitor flow, raw material and finished product flow etc.
  • Organisations chart 
  • Are there available job description for key personnel?
  • Number of staff and their qualification
  • Is there a clear separation of responsibility for production from QC?
  • Is there a clear separation of personnel handling animals, microorganisms and  product? By written procedure.
  • Are the name and qualification of those responsible for approving lot processing records registered with NCA?

Key Personnel

  • Are there sufficient key personnel to supervise assigned functions? - Production, Filling, Labeling / Packaging, Quality Control, Engineering, Maintenance, Quality Assurance and Other departments.
  • Are they skilled/trained in fields such as biology, microbiology, chemistry, veterinary medicine, chemical or industrial engineering, etc?


  • Are there on the job training procedures for new employees?
  • Are training and education records available? - Are they current? Are they filed with the supervisor?
  • Does a GMP training programme exist? - For new employees? Annual update for all staff? Are records maintained?
  • Is there training in containment procedures? - By written procedures? Are records maintained?

Personal Hygiene

  • Are appropriate protective apparel required?
  • Is there gowning SOP for production staff?
  • For other staff entering production areas?(Engineering/Maintenance; Cleaners; QC samplers; QA auditors)
  • For staff in the Quality Control Lab?
  • Are staffs instructed to report health or  medical problems that may have an  adverse effect on the product?
  • Is there a medical monitoring programme to ensure protection of staff and product?Vaccination where applicable? For all employees? For contractors?
  • Do controlled entry requirements exist for: Production areas? Testing areas? Animal areas?
  • Do procedures exist for preventing  unauthorized entry into: Production areas? Storage areas? Quality control areas? Animal areas? Are the procedures in writing?

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