Back in 2010, a group of us (new OGD CMC reviewers) were undergoing an orientation and training course on Abbreviated New Drug Application (ANDA). The course covered various aspects of the role as a CMC reviewer. These courses included law/regulatory issues, review process for Chemistry, Manufacturing, Controls, Microbiology, Bioequivalence, and Labeling. After this course I being a Pharmaceutical Scientist coming from industry with many years of exposure and experience in the Pharmaceutical Product Development, Manufacturing and Technology Transfer joined the Study lunch for CMC reviewer on Formulation and Application to ANDA- December 2010- as a presenter for, "Role of Scale-up Strategy in Product Development – shared with fellow reviewers of OGD the principles and importance of scale-up from ANDA submission batch to proposed large commercial batch and its impact on product quality. In 2014 with the request of the then division director of OGD, Chemistry IV, did coaching and tutorials sessions on Product and Process for new reviewers. After the formation OPF at the forum of Knowledge Sharing Seminar Series– August -2015- presented -Importance of scale-up in Manufacturing Process – for New Reviewer's.
During my career in the Pharmaceutical Industry, I have had collected and compiled many scientific articles, technical know-how, brushier, equipment manufacturer's manual and other related scientific papers and presentations into a binder and designated it as Pharmaceutical Manufacturing Process & Scale-up: Solid Dosage. This remains, to this day, surprise at the success of the "binder" and how many people requested and used it for their understanding pharmaceutical manufacturing process, scale-up and technology transfer for commercial production.
Getting the advice from OPF office and division directors; I thought to make it into a book format. Thus, we compiled and edited this book to shed light on the subject of Pharmaceutical Manufacturing Process; specifically, of the solid-dosage processing and become a companion binder/book for product development scientists, formulator and a reference for process reviewer. It has been compiled and edited in response to requests for clarification and questions I have come across during my tutorials class teaching and giving presentations to various scientific forum, FDA/CDER/OPQ/OPF, AAPS, ISPE and Universities. The Pharmaceutical Technology & Scale-up is a comprehensive compiled documentation of various unit operations for the solid-dosage process and is hopefully a helpful reference source for those involved in the development, production, control, or regulation of pharmaceutical manufacturing processes.
Masih Jaigirdar, September 22, 2023
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Masihuddin Jaigirdar
Pharmaceutics Expert (FDA & Industry Sector)
MJ Consultant
Silver Spring MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.MasihuddinMasihuddinMasihuddinMasihuddin
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