The latest cGMP was published in 2016, theQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.This 58-page document provided some excellent updates to prior cGMP for the industry, but it also sparked more questions than it answered in the eyes of many pharmaceutical organizat...
cGMP goods undergo significantly more testing, as well as newer, more in-depth testing. cGMP also goes beyond proper production, and is put in place to ensure proper use of new manufactured goods. It goes above and beyond to make sure that the quality of the new pharmaceutical is used for...
"GMP" stands for "Good Manufacturing Practice", guidelines ensuring product quality and safety. "cGMP" is "current Good Manufacturing Practice", emphasizing the most recent standards and technologies in manufacturing.
For example, in the United States, GMP is enforced by the US FDA through Current Good Manufacturing Practices (CGMP) which cover a broader range of industries such as cosmetics, food,medical devices, and prescription drugs. TheFDA conducts facility inspectionsto assess if a manufacturing company c...
Compounded drugs have to follow industry standards, and the United States Pharmacopeia (USP) Convention sets those. If they’re made in an outsourcing facility, they have to follow good manufacturing practice (CGMP) rules that cover how they’re made, processed, and packed. In addition to lic...
In a pharmaceutical context, this could mean testing a completed drug batch. If your critical quality attributes aren't achieved, the batch is discarded and a new one created. With this in mind, let's look closer at the quality assurance vs control breakdown. ...
Scaling up production while maintaining product quality, consistency, and purity is also challenging, often requiring technology transfers between facilities. Compliance with current Good Manufacturing Practice (cGMP) regulations adds further complexity, ensuring that every batch consistently meets strict ...
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they only address part of the overall cleanroom qualification and monitoring equation for the pharmaceutical and medical device industries,” he says. “Additional tests should be performed; depending on the product that is manufactured in the cleanroom and where the facility is located, those tests...
Adhering to the FDA’s cGMP guidelines is an integral part of this approval process. Any discrepancies can lead to delays or outright rejections of approval applications. Inspections: To ensure companies adhere to clinical cGMP standards, the agency frequently conducts audits. These inspections can ...