15/16 February 2022
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: