What is FDA Readiness exactly?

Recommendation

5/6 October 2023
Heidelberg, Germany

Quality Culture
People Empowerment in GMP

Many pharmaceutical companies would like to achieve a so-called "FDA Readiness". What should be understood under this term? And does everyone have the same understanding of it? Most of the time, this kind of readiness is associated with an all-embracing quality objective. All pharmaceutical quality systems in operative units must be at such a high level that they would be ready for an inspection by the US American Health Agency - FDA - without any major preparations. A pretty noble goal. This is perfectly understandable for pharmaceutical companies in the USA as they can be inspected regularly and unannounced by the FDA. They have thus created own functions - partly an entire group - with no other duty than that. Such "Inspection Administration" is settled in the quality units (i.e. Quality Control Unit or Quality Assurance); those are always ready and prepared to welcome inspectors and accompany them through an inspection at any time. Moreover, they try to achieve and maintain a consistent and high cGMP level in collaboration with all units involved.

Such an organisation form is almost only to be found in the USA. Although outside the U.S it is also the goal to establish a consistent and high GMP level, FDA inspections are prepared individually as they are - mostly - announced. Only then, preparations targeted to this inspection can begin and they are often associated with great efforts.

For both approaches it is essential to question and understand the cGMP systems in the company in order to identify potential weak points and Compliance risks, and to supervise them thanks to efficient Management Review and CAPA processes. This should ideally result in on-going improvement of quality and associated systems.

When is someone ready for the FDA inspection? The following questions may be useful:

• Do you examine all your processes critically and without bias - as the FDA would?
• Have you identified, evaluated and tackled all internal and potential compliance risks?
• Are you aware of the current inspection trends and possible focuses specially related to your product?
• Have you involved potential customers, partners and service providers in the information and evaluation?
• Have you informed and prepared all the colleagues involved? Are all the roles clearly assigned?
• Are you sure that all your colleagues are competent enough to answer the inspectors' questions and provide clear information about the processes and documentation?
• Have you established procedures about how to handle the inspection and answer the inspectors' questions?
• Do you know how to efficiently put documents at disposal?
• Have you developed strategies to discuss possible compliance weak points during the inspection?
• Do you know what is important after the inspection and how to formulate possible answers?