Honesty Is Still The Best Policy!

Amit Rajan, Managing Director, Prosfora Technologies, says that instilling a culture of compliance in a pharma set up is about nurturing, training and development of all the staffs concerned, on a continuous basis. It’s also about nurturing and inculcating an important cultural attribute, the need for being honest

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The term Good Manufacturing Practice (GMP), implies the standards or good practices followed in core manufacturing of any item or product. However, it encompasses a broad spectrum of activity starting from testing, manufacturing, labelling and stability studies when used in the context of pharma products, interchangeably called as drugs or medicines.

The pharma business is an extremely regulated one which the manufacturers have to comply in letter and spirit. These regulations have been codified in form of laws or guidances published from time to time by various pharma regulatory agencies across the globe. Compliance to the GMP code laid out, have, thus become a key rallying point between the pharma manufacturers and the regulators worldwide in recent days.

Significant violation to GMP was noticed at your manufacturing unit based at……...

Numerous observations were made which were non compliance to the GMP requirements of 21 CFR part 210 &211 at your drug product site located at …….