European Pharmaceutical Review

APRIL 8, 2025

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility.

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Documentation Packaging Pharmaceutical Manufacturing 52

GMPSOP

MARCH 17, 2023

ISO 9000:2005 Sec. Additional documents included each month. Subscribe Corrective action vs preventive action examples In pharmaceuticals, corrective and preventive action (CAPA), is conducted at the implementation stage of most quality concern investigations. Additional documents included each month. When to raise CAPA?

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Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

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Documentation Compounding Pharmaceutical Manufacturing 52