New Question FDA Inspectors May Ask You at Your Next Inspection

ARE YOU READY-I was intrigued by a recent conversation I had with Barbara Unger, the editor-in-chief for GMP Regulatory Intelligence.  It’s becoming increasingly clear that the FDA wants to make sure you have a rigorous process to stay updated about the latest regulations and guidelines.  Here’s what she had to say:

Barbara Unger:

Small and mid-size pharmaceutical companies may ask why they should spend limited resources on a GMP Intelligence program. The answer is simple, it saves money. The return for a comprehensive GMP Regulatory Intelligence program can far outweigh the cost. Let’s look at this from two different perspectives: regulator expectations and an example of the financial value it can provide using enforcement actions for lack of data integrity as an example.

(Today, we’ll cover the Regulatory Expectations. Look for the financial value case study next week)


ICHQ10, Pharmaceutical Quality Systems, requires the “Monitoring of Internal and External Factors Impacting the Pharmaceutical Quality System” including “emerging regulations, guidance and quality issues…”  This type of program is no longer a nice-to-have, but is now expected by regulators.  During recent GMP inspections, both FDA investigators and EU inspectors have asked companies how they manage this function.

Further, ICHQ10, Pharmaceutical Quality System, identifies Knowledge Management as an “enabler” of an effective Quality System. A comprehensive GMP Regulatory Intelligence program should be a component of this effort. GMP Regulatory Intelligence functions as an early warning system allowing a company to make changes in practices and procedures, if necessary, before a regulatory authority imposes a costly enforcement action. Even when changes are not necessary, this informs staff about the areas of focus they might expect during inspections. Key to a successful program is active surveillance of publicly available information, supplemented by subscription based data. This should be followed by analysis and communication to a wide group of Operations, Regulatory and Quality staff to ensure the knowledge is not limited to functional silos.

When the FDA inspector asks you what your SOP is to stay on top of regulations and guidance, what is your answer? Let Barbara cover this function for you by reading the weekly GMP Regulatory Intelligence.

More about Barbara Unger>>

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