Quality Assurance/Quality Control

Sep 28, 2017
By Pharmaceutical Technology Editors
The draft guidance gives recommendations for reproductive toxicity testing and labeling.
Sep 19, 2017
By Pharmaceutical Technology Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Sep 14, 2017
By Pharmaceutical Technology Editors
The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.
Sep 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
Sep 08, 2017
By Pharmaceutical Technology Editors
Scientists at Scripps’ Florida campus showed for the first time that quality control steps exist in the production of proteins, which presents a target for anti-cancer drug development.
Sep 02, 2017
Pharmaceutical Technology
When it comes to getting the best out of quality by design, timing is everything.
Sep 02, 2017
Pharmaceutical Technology
Forced degradation studies can identify stability problems for drug substance and drug products.
Sep 02, 2017
Pharmaceutical Technology
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Aug 16, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
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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