The conduct of audits is a key part of our Pharmaceutical Quality Systems to give us information on the activities and standards to which our suppliers and contractors operate. It is important for us to have confidence in the quality of the materials and products that are manufactured and analysed and in control of the supply chain, with the goal of the assurance of product quality for the public and for patients.

There are a number of requirements for a GMP/GDP (Good Manufacturing and/or Distribution Practice) audit to be meaningful:

  1. Experience and expertise of the auditor(s).
    • In selecting an auditor, their experience and expertise need to be commensurate with the scope of the audit and with the circumstances of the audit. For example, is it reasonable to expect an auditor who does not have specific product experience/ expertise to be sufficiently competence to evaluate compliance of a manufacturing operation for that product type, particularly where they are GMP/GDP compliance concerns?
  1. Scope of the audit covers the essential aspects of GMP and GDP as appropriate and as directly relevant to the contract between the parties.
    • Audits are not tick-box exercises and site visits masquerading as audits are unlikely to meet GMP/GDP requirements.
    • The Quality Agreement between the parties should be considered as part of the scope of an audit as this will define specific roles and responsibilities of the parties, compliance with which should be confirmed during the audit.
  1. Audit duration
    • The duration of an audit needs to be appropriate to the scope of that audit and to whether the audit is an initial qualification audit, a topic specific audit or a re-qualification audit.
    • Unless the scope of an audit is limited to specific topics, there is limited value in seeking to perform an audit of a manufacturing facility in a single day. The opening and closing meeting alone will require a number of hours, leaving limited time for the auditor to view activities and evaluate data and documentation.
    • There is a risk that the audit becomes a ‘tick box’ exercise which will not satisfy our quality and compliance drivers for conducting audits.
  1. The audit is performed in a manner that allows the auditor to view and evaluate activities in real-time.
    • On-site audits are ideal; however, virtual audits have been our reality for the past few years in Covid times. They have a value and there is a place for them in a hybrid approach to performing third party audits. See our article from July 2021 on virtual audits.
  1. CAPAs (Corrective & Preventive Actions) to address audit observations/ GMP/GDP deficiencies are proposed by the auditee and agreed with the auditor.
    • CAPA is an essential part of the audit process as it enables the correction of current GMP/GDP issues and the prevention of future problems.
    • The role of the auditor is to confirm satisfactory compliance with the relevant GMP/GDP standards and requirements. This requires a direct involvement of the auditor in the CAPA process.
    • Where Critical and/or Major GMP/GDP deficiencies are identified, the auditor will need to know that appropriate CAPAs have been raised to address the underlying causes. They may need to see evidence that the CAPAs have been implemented. They may even wish to see evidence of the effectiveness of some of those CAPAs.
    • The auditor and auditee need to agree the basis on which the auditor will close the audit and confirm satisfactory GMP/GDP compliance for the operations covered by the scope of the audit.
    • Asking an auditor to simply perform an audit and not to be involved in the CAPA process is potentially compromising for the auditor, particularly in a qualification or requalification audit, where they are confirming satisfactory GMP/GDP compliance.

As part of our Audit Service, MIAS Pharma collaborates with our clients to define appropriate CAPAs to address audit observations. We will agree with you the CAPAs that need to be closed before we can confirm satisfactory GMP/GDP compliance of the activities that were the subject of the audit. We will also agree with you the evidence our QPs need to see to be able to close an audit to support batch disposition.

MIAS is your partner and so, will assist and help you on your journey toward compliance.

resource checklist

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CAPA checklist: questions to ask, CAPA plan, tips for assessing, etc.