Quality Assurance/Quality Control

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.
Aug 01, 2017
Pharmaceutical Technology
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Jul 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
Jul 12, 2017
By Pharmaceutical Technology Editors
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
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
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.
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