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Learning GMP Guidelines

  • 1.  Learning GMP Guidelines

    Posted 04-09-2020 10:15
    What's the best way to become acquainted with GMP guidelines? I'm looking to better my understanding of them for pharmaceutical process position interviews and I've been reading the documents and statutes that I've found through the FDA website, but I'm wondering if there is a better way, such as an industry standard handbook.

    Ethan Johnson
    Biotech Without Borders
    Leonia NJ

  • 2.  RE: Learning GMP Guidelines

    Posted 04-10-2020 01:32
    Dear Ethan, FDA is having several guidelines which are detailed and at time for experts. I trust you are looking for an opportunity in API manufacturing. For beginners and even for practitioners ICH Q7a Guidelines will be good for understanding GMP in manufacturing of API.

    Please see the link below for downloading the same.


    Yaqoob Ali PE
    Y-Chem Consulting

  • 3.  RE: Learning GMP Guidelines

    Posted 04-10-2020 11:41
    Edited by Yingjie Chen 04-10-2020 11:43
    Hi Ethan,
    Good question. You should be able to find guidelines (like 21 CFR and ICH Q7-11) on FDA and/or other websites like ISPE. In addition to familiarize with the guidelines, one of the most critical things is to practice common sense and simulate a sterile manufacturing environment in your mind. Majority of the guidelines are associated with keeping the product safe and within quality specs. As long as you understand this, many of the guidelines should be straight forward.
    There are of course many specific training courses and introductory videos online. Many articles related to GMP can also be found with many professional associations like the PD2M forum with AIChE, ISPE, etc.

  • 4.  RE: Learning GMP Guidelines

    Posted 04-10-2020 19:55
    Hi Ethan,
    I agree with Yingjie that the websites from the FDA and ISPE are good starting points.  If your position involves sterile products especially if the position is a drug product position, then I would suggest looking at the PDA website as well.

    For general pharma texts, I suggest ICH Q8 which you can find at ICH.org and click the Q at the upper right hand corner and the FDA Guidance On Process Validation (2011).  Nature has some good articles that talk about drug development.

    Best of luck with the interview.


    Praveen Ram Prasanna
    Sr. Director and Head of Biologics Product Development
    Cambridge MA

  • 5.  RE: Learning GMP Guidelines

    Posted 04-12-2020 16:32
    Hi Yaqoob, Yingjie and Praveen,

    Thanks so much for the help! I'll take a look at the websites that you referenced. I recently finished my masters degree in biochemical engineering so I'm looking for work in pharma and biopharma. A lot of positions say that GMP knowledge is preferred so I figured that I should pick some up before entering industry.

    Thanks again,

    Ethan Johnson
    Recent MSc Graduate
    The University of Sheffield
    Leonia NJ