Articles — cGMP

cGMP Controlled Raw Materials Best Practices | Newsletter | Issue 06 | 2021

cGMP Controlled Raw Materials Best Practices | Newsletter | Issue 06 | 2021

Recently, the FDA has been providing much heavier guidance - and more Form 483s for objectionable conditions - with respect to the regulatory requirements of cGMP controlled raw materials. As a result, they are also providing more information on overall best practices for these materials. It is critical for those working in the pharmaceutical industry to understand the ever-changing requirements and best practices pertaining to cGMP. Regulations Guiding cGMP Controlled Raw Material are in FDA regulations 21 CFR 211.84 Subpart E: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures Overview of the Regulation Section D of the FDA...

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