GMPSOP

JANUARY 29, 2025

Governments highly regulate pharmaceutical industries. They must follow stringent procedures to validate and maintain their information management systems for GMP compliance.For example, companies located in the USA must comply with the USFDA 21 CFR part 11 regulations. – Documentation of evaluation of each probable cause.

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Documentation Process Improvement Pharmaceutical Manufacturing 94

GMPSOP

MARCH 17, 2023

For instance, you can undertake a list of process improvement works targeting the elimination of causes that have resulted in the defect. The Regulatory Department shall ensure that all relevant information on actions taken is submitted for management review. When to raise CAPA?

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Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Drug Patent Watch

JANUARY 9, 2025

Industry directories, conferences, and networking can all be valuable sources of information. Managing Quality and Compliance Quality and regulatory compliance are non-negotiable in pharmaceutical manufacturing. Work with your CDMO to stay informed about upcoming changes that could impact your project.

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Communication Drug Development Pharmaceutical Manufacturing Process Improvement 52