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Apr 202 min read

WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals

Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...

Dec 30, 20232 min read

USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Nov 1, 20221 min read

USFDA's Notice: CMC Development & Readiness Pilot Program

Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...

Oct 3, 20221 min read

USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules

Earlier today (03-October-2022) USFDA's Center for Drug Evaluation and Research released an important CMC topic and final guidance "...

Apr 24, 20221 min read

USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles

Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...

Dec 18, 20211 min read

CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...

Sep 23, 20211 min read

USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs

On 20.09.2021, USFDA released an updated Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry. This...