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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)Â has issued a Request for...
Sharan Murugan
Nov 30, 20242 min read
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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...
Sharan Murugan
Apr 20, 20242 min read
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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...
Sharan Murugan
Dec 30, 20232 min read
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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...
Sharan Murugan
Nov 1, 20221 min read
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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 "...
Sharan Murugan
Oct 3, 20221 min read
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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,...
Sharan Murugan
Apr 24, 20221 min read
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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...
Sharan Murugan
Dec 18, 20211 min read
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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...
Sharan Murugan
Sep 23, 20211 min read
235 views
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