Achieving Inspection Readiness in Pharma

Why be Inspection Ready?

In the lifecycle of a pharmaceutical company an inspection from a regulatory body is a certainty. Whether it be for the initial approval of your licence or ongoing approval they are going to happen. With the FDA recently expanding its unannounced inspection program a site can no longer rely on having 6 weeks’ notice to prepare. The inspectors can turn up at your gates on Monday morning and you have to be ready to host.

Pre inspection preparation:

There are some key elements to getting ready for an inspection amongst them are arranging who is responsible for what, starting with the backroom team and scribes. Having experienced personnel supporting in the backroom can be a great support for the front room team with pre-screening of documents. Where possible utilise technology such as setting up an inspection teams chat, with clear rules on communication and formatting and of requests e.g. “inspector requests SOP on deviations” rather than “can someone please get the deviation SOP.”

Doing exercises such as mock inspections with either external parties or using members of the internal team can be a great way to get the team into the headspace of how to handle the pressure of an inspection. Using a “hat-on/hat off” technique during these sessions permits immediate feedback and coaching to members of the team likely to be sitting opposite an inspector(s).

Executing the mock inspections also help to identify potential “Achilles heels” and allow you time to either correct them or prepare a storyboard to aid in the explanation of a complex process, deviation or problem.

Preparation of PQS:

In advance of the inspection there are usually requests from the inspector(s) for documents this may include those listed below:

Key Documents

Suggested Actions

• Perform sanity checks on these documents and confirm they are complete, up to date, no gaps are present and any CAPAs are closed or on track
• Review any critical and major changes and investigations will help to ensure familiarity.
• For paper based PQS’s verify that you can quickly retrieve any records

Preparation of Premises

Key documents related to your facilities and equipment to have available can include:

Key Documents

• HVAC System Site Drawings and Validation Reports​
• Water System Site Drawings and Validation Reports​
• Clean Steam Site Drawings and Validation Reports​
• Compressed Air Site Drawings and Validation Reports
• List of Critical production equipment​
• List of Critical laboratory equipment​
• Cleaning Validation program​
• Validation Master Plan

Suggested Actions

• Performing regular walkthroughs of manufacturing areas with people familiar and unfamiliar with the area. This can help to point out or ask questions about things that people familiar with the area may miss.
• Have a 5S approach to all areas and confirm that all equipment are fully qualified and log books are up to date

Preparation of Personnel

With regards to the personnel at your site, key documents would include:

Key Documents

• Training Records
• Evidence of audit qualifications
• Continued Professional Development (CPD) for QPs
• Annual GxP training
• Annual Training Plan

Suggested Actions

• Personnel to review their training records for completeness
• Confirm evidence of annual GxP training and CPD for QPs is available
• Ensure awareness of inspection occurrence and inspection behaviours

In summary, the more time and effort put into preparing for an inspection the easier it can be. It comes down to the old saying “fail to prepare, prepare to fail”. Ensuring that the team know their processes, are well drilled and are open and honest with the inspector can lead to a smoother inspection process.