Bioequivalence and Bioavailability Forum

Hi nobody,

THX for sharing; bizarre reading.

[Dilip] Shah [Secretary General of the Indian Pharmaceutical Alliance] said the FDA should take a less aggressive and more helpful attitude to teach [sic] manu­fac­turers how to meet its standards.
“I told US FDA that your goal and our goal is common: providing safe effec­tive and quality medicines to US citizens. How best can we do this? Can we work together?
“When a student in a classroom is lagging behind the onus is also on the teacher to help the student catch up with the rest of the class. This is the solution, not policing and filing 483s.”

I would say it’s not the job of inspectors to teach companies the rules of GxP – established for decades. Being willing to read helps a lot. Courses are available every­where. Ignorance is no excuse.
To stay with the school-analogy: Inspectors are examiners, not teachers. When you take an exam you should have mastered the assessment load – unless you hope for sheer chance or “passing by cheating”.

IPA’s Secretary General also criticised what he called a lack of guidance for ma­nu­fac­turers on how to implement US laws.
In the UK, an Act of Parliament, law, and guidelines on how to interpret it “are all compiled together and available in one book.”
“The US FDA only have an Act, and guidances are issued from time to time but there is no compilation available of those guidances.
“So there is a need for US FDA to put its documents in order.”

I beg your pardon? Never came across CDER’s guidances (not to speak of the 1208 [sic] product-specific guidances published so far)?

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PS: https://www.in-pharmatechnologist.com/Article/2014/12/09/CPHI-India-experts-say-data-fraud-dragging-down-Indian-manufacturing

Ajit Dangi, Chairman of Fulford India, a Merck % Co.subsidiary, claimed to have seen statistics showing “in life sciences, almost 35% of the bio data are embellished – I’m using a very polite word. If that’s the case, you know the culture has a problem and that’s why data integrity and GMP go hand in hand.”