As per WHO recent guideline for GMP audit following information to be updated -
Administration
- 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?
Training
- 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?
Read also: GMP Audit Checklist (Part-2)