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Nov 302 min read

ICH Seeks Market Consultation for Global Post-Approval CMC Assessment Cloud Solution

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for...

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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...

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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...

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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...

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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 "...

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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,...

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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...

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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...

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