Raise your hand if you have mixed feelings about inspections, regardless of whether they’re internal audits, the ones from your client/MAH or, perhaps the scariest, from the Health Authorities. Is preparing for an audit the busiest time on site – everyone’s bearing extra workload and stress on top of the routine work? Meanwhile, so very exciting – everyone’s working in unison to assure a satisfactory result!
Throughout my career, I’ve been on both sides as auditor and auditee and am still enjoying each role greatly. I bet you’d feel the same once you see the true nature of inspection as part of the monitoring programme (though it might be in the most stressful form) and then driving continual improvement. This would be my first tip helping a site to prepare for an inspection and be ‘inspection ready’ – the adaption of the mindset that inspection and auditors are not your enemies.
An inspection is supposed to review what you always apply within the organisation. Hence if you are practicing GxP in your routine operation, you are inspection ready at any time point. But if this picture resembles your site situation, I could imagine how painful it would be to get ready, and it only gets worse for future inspections with issues recurring and the facility ageing.
Certainly, the maturity of GxP implementation varies among organisations. Hence the level of effort required for inspection preparation varies from an overall scrutiny of the whole system (e.g., preparing a manufacturing site for the first GMP inspection) to an assessment of a particular system observed with an adverse trend (e.g., review and remediation of water system OOT). The latter circumstance is obviously driven by a specific issue, and it’ll follow a process similar to the deviation investigation and CAPA methodology. The former circumstance requires a more thorough and systematic approach, and in many cases, it’ll lead to the assessment of a particular area and system based on the review of the overall system. Likewise, during the investigation of a particular issue, a systematic failure might be identified, which calls for an overall scrutiny.
Each site has its unique situation, as also the strategy for inspection readiness. I’d always apply the No deviation 4-Step approach and, in general, the methodology used for ‘understand’ and ‘observe’ could be one of the following:
1. When a site lacks confidence in the readiness or overall assessment of its compliance status, or is going for the very first inspection, it would be recommended to conduct a thorough mock inspection by a third party or a corporate audit team.
2. If a site has been practicing GxP with a good understanding and is targeting at a higher level of compliance (e.g., local GMP to international GMP) or more stringent requirements, it may be sufficient to establish an inspection readiness checklist that helps identify the gaps.
3. Finally, for the site equipped with higher maturity of quality and compliance, a review of results from the current monitoring programme suffices. A great place to start with is the management review programme.
There might still be unclearness when organisations execute the gap assessment against regulatory requirements, as those clauses often only lay down the high-level requirements rather than details on procedure and implementation. This requires the organisation to understand and apply the requirements in their own context, e.g., different products, different operations, different systems, and eventually, different risks to patients.
I’ve worked in manufacturing sites for a sterile product costing thousands of dollars for a few milligrams, and sites for an excipient of non-sterile product costing less than a hundred dollars for dozens of kilograms. You could imagine that the level of complexity of the systems differs greatly. Other examples could be the comparison between a warehouse storing finished products only and a warehouse repacking and storing finished products, or a manufacturer of primary packaging materials and a manufacturer of secondary packaging materials.
Even with a great effort on preparation, site might not be able to complete all the required CAPAs identified from the gap assessment prior to inspection. However, at the very least, it’s recommended to demonstrate the awareness of the gap, a plan in place to rectify it and justification that product quality is not compromised in the meantime.
All the work will require a real understanding of your product, process and risk – science and risk-based. Personally, when I’m assessing an organisation which has good knowledge of their product and process and no sign of intentional data integrity issues, I’d be more confident of the inspection outcome.
Lastly, however ready your system is, it’s still a good practice to conduct an inspection awareness, behaviours and procedure training/refresher to ensure the team handles it appropriately. Also, an important add-on for virtual inspections is the readiness of required tools, hardware and the personnel’s skill in using them.
Once you are ready for the inspection, congratulations on having begun the compliance journey! The goal is never to achieve the satisfactory outcome of an inspection but to always maintain it.
For quality is a mindset.
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With 15 years of experience in the global pharmaceutical industry, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both Consultant and End User roles. With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.
