What is a GMP Inspection?

What is a GMP Inspection?

GMP inspection (Definition)

A GMP inspection (‘GMP compliance audit’) will generally involve an onsite visit by a specially-trained Inspector/Auditor; who examines various components of the manufacturer’s Pharmaceutical Quality System (PQS). The GMP inspection generally includes, but is not limited to, reviews of manufacturing procedures (SOPs) across the product lifecycle, supplier qualification procedures, facilities and equipment including validation, documentation (e.g. flow charts, batch tracing records, laboratory testing reports), deviations handling (CAPA systems), complaints monitoring systems, recall procedures, and employee training programs.


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Timeframes: how long does a typical GMP inspection take?

  • The inspection (GMP compliance audit) may be held over a single day or over several days.
  • The GMP inspection is followed by a formal inspection report detailing specific areas of non-compliance as well as areas for improvement.
  • GMP non-compliance issues may be called ‘audit findings‘ or ‘inspection findings‘.
  • Manufacturers should address non-compliance issues in a timely and appropriate manner.

 

 


What happens after receipt of an inspection report that identifies non-compliance issues?

Follow-up site visits and/or subsequent communication between the Inspector and the site’s Owners and/or Quality Department is typically required; particularly where serious GMP non-compliance issues are identified during the inspection.

  • Quality Risk Management (QRM) principles, detailed investigations, CAPA system reviews, and change controls are often required.
  • Investigations, corrective actions/control measures to address non-compliance audit findings should be fully documented.
  • Period reviews of the PQS and investigations into the effectiveness of control measures are required.

 

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FAQs on GMP Audits

Frequently asked questions in relation to Good Manufacturing Practice (GMP) Inspections/GMP compliance audits


FAQ#1: Are GMP inspections always pre-scheduled — or are ‘surprise inspections/unexpected GMP audits’ common?


Manufacturers should be ready for a GMP inspection/GMP audit at all times.


FAQ#2: What is the primary purpose of a GMP inspection?


FAQ#3: What is meant by a ‘hybrid GMP audit’  (‘hybrid inspection methods)?

Hybrid GMP inspections (hybrid GMP audits)

Hybrid GMP audits (regulatory compliance inspections, conducted partially onsite and partially using desktop auditing methods/ICT) are growing in popularity in 2020 and 2021, in response to the impact of the pandemic.


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FAQ#4: Are remote GMP compliance inspections increasing during the Covid-19 pandemic?

Estimated frequency of remote auditing in GMP environments

  • Yes, remote inspections and ‘desktop audits’ are increasingly being used as an alternative auditing option, when site visits are untenable.
  • The ratio of onsite GMP audits vs remote audits is currently fluctuating.
  • Onsite audits remain the preferred method; however, the benefits of remote auditing are leading to global changes in auditing schedules and auditor training requirements.

FAQ#5: Are there special requirements for conducting a GMP inspection remotely (remote auditing) including auditor training for conducting a remote site inspection?


FAQ#6: What if there is a delay in responding appropriately to non-compliance audit findings in the GMP Audit Report?

Consequences of GMP compliance breaches

Failure to remedy identified non-compliance issues in an appropriate, timely manner, could lead to a loss of manufacturing licences/marketing approvals, forced facility closures, and/or criminal charges/jail time for owners and other responsible persons.


FAQ#7: How are GMP auditors/inspectors trained?

Required skills for auditors:

Required knowledge and skills for GMP auditors/Quality Department inspection personnel include — but are not limited to — keen observation skills, rapport-building skills, interviewing skills, analytical skills, investigative skills, report writing skills, organisation skills, ICT knowledge, and experience in GMP compliance and regulated industries.

GMP compliance inspector training and internal auditor training


FAQ#8: What do GMP inspections involve?

GMP inspections may involve:

  • pre-scheduled inspections as well as unannounced inspections
  • Auditing Agendas/Inspection Agendas
  • GMP auditing checklist(s)
  • References to regulations (such as the FDA’s CFRs, the TGA’s Therapeutic Goods Act) and guidance documents from PIC/s
  • Guidance publications from relevant Regulatory Authorities regarding expectations for Pharmaceutical Quality System (PQS) and other pharmaceutical manufacturing controls
  • A GMP Inspection/GMP auditing report that may detail:
    • Areas for improvement
    • Audit findings and/or warning letters
    • Citations and or directives to cease production and/or close a facility (for example, if serious GMP breaches and/or repeated GMP breaches are discovered during a GMP inspection)

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FAQ#9: What is the value of an inspection checklist (GMP audit checklist)? 

GMP Audit Checklists (value):

GMP inspection checklists can vary, however, depending on:

  • types of products being manufactured (e.g., based on the product risk profiles)
  • the history of the manufacturer/manufacturer’s reputation
  • prior GMP inspection findings/audit findings
  • other factors.

FAQ#10: How are guidelines and checklists used during GMP inspections?

Auditing guidelines used during GMP compliance inspections:

GMP guidelines provide a framework that manufacturers can use to implement specific measures and quality controls in order to meet expected quality, safety and efficacy standards for medicinal products including pharmaceutical products, medical devices, and biological medicines.

Additional documents published by regulators such as the FDA, TGA, MHRA, EMA etc. can provide “interpretative guidance” (these are called “Aide Mémoires (AiM)” — and are useful to help manufacturers know what will be expected during a GMP inspection of their facilities, equipment, processes, employees/personnel records, contracts/GMP agreements/technical agreements/contractor audits, quality monitoring systems, and other quality controls.


Overall, a GMP inspection helps verify that a manufacturing organisation and its employees, contractors, and suppliers are consistently meeting expected quality standards during every stage of manufacturing and distribution.


Summary of Benefits of GMP Inspections

A GMP inspection helps to ensure a product “released to market” is safe and effective to use by patients and other consumers; including proper packaging and labelling.

These inspections serve to verify that expected quality standards are being met by manufacturers and their distributors during all steps in the manufacturing process.

These quality standards (GMP regulations/GMP guidelines) are published by PIC/s and other Institutes, Agencies and Regulatory Authorities (examples: FDA, TGA, EMA, MHRA).

Review the list of Regulators that conduct GMP compliance inspections/audits.


Need to get your Employees trained in GMP compliance and auditing?

Learn what to expect during a GMP inspection by a regulatory authority:


 

Recommended courses for GMP industry professionals and GMP engineers in the pharmaceutical or medical device manufacturing industries

Pharmaceutical Manufacturing Fundamentals (PMF) series of four courses

Other online GMP training options