Impurity profiles of API - Challenges for cGMP Inspections in MSME: GMP audits and API impurity profiles

Chakravarthy, Dr. B. K.

ISBN 10: 6138502574 / ISBN 13: 9786138502579

Published by Scholars' Press, 2018

About this Item

144 pages. 8.66x5.91x0.33 inches. In Stock. Seller Inventory # zk6138502574

Bibliographic Details

Title: Impurity profiles of API - Challenges for ...

Publisher: Scholars' Press

Publication Date: 2018

Binding: Paperback

Condition: Brand New

About this title

Synopsis:

API’s are being manufactured all over the globe at varied conditions keeping updated cGMP regulations. However, due to business constrains many API manufacturers especially micro, small and medium scale entrepreneurs (MSME) do tend to neglect systematic continuous recording and documentation process as per cGMP guidelines and have to pay heavy price when cGMP audits take place. API manufacturers do constant innovative research to minimise cost and time to be globally competitive. New innovations can lead to development of some unknown impurities, may be within of quantitative limits but unknown qualitative factors and if care is not taken for such molecules being identified and not controlled before release for open market with proper technology transfers,it is likely that newer impurities can be developed and contribute to unreported clinical toxicity findings and there is a danger that a well established and potential API is forced to be restricted or withdrawn from clinical usage. GMP inspector cannot verify each and every batch manufactured for any deviations, but sure to appreciate if followed a dictum “do what is written in SOP and write what has been done"