GMPs

Aug 31, 2017
By Pharmaceutical Technology Editors
The International Society for Pharmaceutical Engineering announced the release of ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition).
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
Aug 18, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
Aug 18, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency published guidance on identifying trading partners under DSCSA.
Aug 14, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Aug 14, 2017
By Pharmaceutical Technology Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Aug 10, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Aug 02, 2017
Pharmaceutical Technology
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Aug 02, 2017
Pharmaceutical Technology
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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