Quality Systems

Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Jul 21, 2017
By Pharmaceutical Technology Editors
Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.
Jul 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.
Jul 12, 2017
A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.
Jul 12, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling Sten Z and M1 Alpha capsules because the product contains derivatives of anabolic steroids, which makes them unapproved drugs.
Jul 12, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Jul 10, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 02, 2017
Pharmaceutical Technology
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Regulations and business changes have altered Big Pharma’s place in the industry.
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