Many pharmaceutical companies would like to achieve a permanent state of so-called “Audit Readiness”. Most of the time, this kind of readiness is associated with a well implemented quality culture. It is part of the greater goal to establish a consistent and high GMP level. Maintaining regulatory compliance across the product lifecycle, from product development to clinical supply and commercialisation, is critical to ensuring the continuity of your operations. Attaining a sustainable state of permanent inspection readiness should be a primary objective. To achieve this, it is necessary to ensure that a robust and effective Pharmaceutical Quality System is in place, and to monitor its ongoing effectiveness and suitability through periodic GMP audit and quality management review.
In addition to this audit readiness, when an audit is announced preparation is key to a successful audit. So, if an audit is announced or if you want to ensure you are audit ready for an unannounced inspection here is a checklist to get started:
- Have you assessed all your processes critically without bias as the auditor would?
- Have you selected key persons from every department who have a full working knowledge about the documents and systems? These key people need to be able to explain systems to the auditor. Ensure that all representatives are competent enough to answer the inspectors’ questions and provide clear information about the processes and documentation.
- Have you informed and prepared all personnel involved? Are all the roles clearly assigned? Have you established procedures about how to handle the inspection and answer the inspectors questions?
- Have you scheduled mock audits or internal audits? Mock audits or internal audits should be performed regularly and before the inspection. It will increase the confidence of the people facing the auditors. Internal or mock audits are the foundation for a successful audit.
- Have all regulatory updates been implemented? Ensure you have fully implemented any new regulations and are prepared for any upcoming regulatory changes. Auditors will like to see early implementation of changes.
- Have you adequately reviewed all critical/major investigations, new equipment validations, critical/major complaints? Auditors often request lists of these items.
- Are you aware of the current inspection trends and possible focuses especially related to your product?
- Have you involved partners and service providers in the audit readiness evaluations?
- Have you planned a system to efficiently put documents at disposal during an audit?
- Have you developed strategies to discuss possible compliance weak points during the inspection?
- Have you identified, evaluated and tackled all potential compliance risks? Are these documented in formal risk assessment documents that can be presented to the auditor?
- Have you developed departmental action plans ahead of the audit? A plan should be put in place with a delegated audit preparation lead per department. A list of actions should be put together and monitored periodically leading up to the audit. Identify key exposures within each area, list exposures, include a review of completed investigations, new product introductions, prioritise major/critical exposures, agree actions, assign responsibility & timelines for each action, periodic review & progress updates and move resources if needed.
Preparation is key to successfully and efficiently streamlining and managing the inspections. If an audit is announced, remember the auditor is ultimately ensuring that the key GMP items are completely controlled such as facility, equipment, raw materials, operating procedures, validated processes & trained personnel. Get inspection ready today!