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WHO's Newest Updates in Pharmaceutical GMP Guidelines
Saher Binte Haider
April 23, 2024
GMP is a fundamental concept in pharmaceutical manufacturing and distribution. Poor-quality medicinal products can lead to adverse effects, treatment failure, and even death. Implementing GMP assures that pharmaceutical products are produced with the high
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The Future of GMP in the Pharmaceutical Industry
Saher Binte Haider
March 21, 2024
The pharmaceutical industries are continuously evolving, which is why the future of GMP is on the brink of significant change.
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New regulations in the Year 2023 for different regulatory bodies around the world
Muhammad Asim Niazi
January 23, 2024
This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.
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What is MAH policy in China?
ChatGPT/PharmaSources
November 09, 2023
In China, the Marketing Authorization Holder (MAH) system refers to a policy shift in the regulation of pharmaceutical products.
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Suggesting on the best practice of becoming MAH of a drug in China
ChatGTP/PharmaSources
November 09, 2023
Becoming a Marketing Authorization Holder (MAH) for a drug in China involves navigating a complex regulatory landscape.
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Quality management system and Digitalization end-to-end process: Pharma 4.0 and Industry 4.0
Shruti Talashi
September 14, 2023
Drugs that are available in the market should not deviate from its standardized quality parameters.
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NMPA's Progress in Joining PIC/S
zhulikou431/PharmaSources
July 12, 2023
This article will introduce China NMPA's progress in joining PIC/S and the latest change in GMP guideline of PIC/S respectively.
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cGMP regulations in pharmaceutical industry
Muhammad Asim Niazi
June 14, 2023
Let’s look at some importance of GMP in pharma manufacturing and see how it benefits the pharma manufacturer.
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What’s the known so far with Medicines & Good Manufacturing Practices?
Shruti Talashi
May 16, 2023
Be it a pharmaceutical or bio-pharmaceutical, both are regulated by the FDA, US. And it is mandatory for both kinds of manufacturing companies to follow the current Good manufacturing practices (cGMP) inprocess of getting certified from USFDA.
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What is Bioburden and how to monitor them?
Muhammad Asim Niazi
May 11, 2023
Bioburden is defined as quantity of bacteria on an un-sterilized surface. It is the measure of contamination on any surface before being sterilized.