• As part of the Manufacturing Authorization Holder evaluation to support a QP declaration of compliance to ICH Q7 for the API used as a Starting Material in the manufacture of Human or Veterinary Medicinal Products.
  • As part of Supplier Qualification, a Pre-approval audit may be necessary “Start-up’ audits would review the adequacy of new facilities and/or manufacturing processes prior to full scale production.
  • As part of a periodic supplier evaluation, a ‘follow up’ audit would be scheduled to monitor and ensure an adequate level of compliance is being maintained.
  • A ‘for cause’ audit may be performed to investigate a specific quality failure or process deviation and/or to prepare for a regulatory inspection

The industry has to deal with an ever-increasing audit requirement as part of implementing directives that require periodic audits as part of supplier qualification, but also with different kinds of audits, other than GMP that cover, safety, health and environmental aspects. Auditees may become stressed with overload and the potential advantages of audits are often going to be lost

FWQRC audit program is designed to ensure that effective, independent audits are performed by IRCA certificated Lead Auditors. The audit will not be seen as interrogation with the auditee as permanent looser, it will be the comparison of what is laid down to what is in place

The context of a review by certified auditor with objective of not only monitoring compliance but also identifying areas for improvement to the benefit of the business

The outcome of the auditing shall provide the following benefits to the industry:

  • Effective assessment of GMP compliance
  • Reduced costs
  • Improved performance
  • Facilitating harmonized guidelines for auditing
  • Increased external confidence
  • Inspection readiness
  • Trouble free operation

Legal Requirements

Internal audit (First party audit):

These may be conveniently sub divided into “local” audits of individual plants and departments or projects, or “corporate” audits performed by a central auditing group in order to assess conformance with corporate policies and standards. These audits are likely to be structured to systematically provide in-depth knowledge of the effectiveness of the quality management system over the defined period of time. It is an internal check against internal, and average where appropriate external, specified requirements reflecting the legal situation

External audit (Second party audit):

External audits may be further subdivided with regard to their focus. The search for evidence of an effective quality management system is a common goal, the level of required GMP may differ depending upon the criticality of the material and or services. Audits may also be used to approve suppliers and contractors

By their very nature external audits performed on suppliers and or contractors are checks against unknown environments of a product or service. External audits are characterised as a check against relevant international and or local requirements given by the authorities

Onsite auditing is recommended for suppliers of key services, critical raw materials, and contractors used for outsourced manufacturing activities


It is a major concern if management uses audits for assessing or grading (e.g., salary) people. In this case it is likely the auditees will be defensive and not willing to cooperate, which is unacceptable, this will undermine the benefits of audits; auditees will feel themselves as examined by specialists (auditor) on areas they are not responsible to be at the state of the art. The consequence is an unproductive atmosphere and there could be attempts to hide the truth

Need help conducting GMP Audits?

Our Quality professional bring direct experience in food, pharmaceutical, biotechnology, cosmetics and medical device development and manufacturing to help you understand and address quality assurance needs at every stage of product. We offer auditing programs for food, drugs, cosmetics and medical device industries across the globe

FWQRC has a proven track record in facilitating success for numerous life science organisations.

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