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September 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
September 02, 2017
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Forced degradation studies can identify stability problems for drug substance and drug products.
When it comes to getting the best out of quality by design, timing is everything.
August 16, 2017
Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.
August 02, 2017
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.
August 01, 2017
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
July 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
July 12, 2017
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.
July 02, 2017
This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.