Regulatory/GMP Compliance

Jan 05, 2018
By Pharmaceutical Technology Editors
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
Jan 03, 2018
By Pharmaceutical Technology Editors
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
Jan 02, 2018
Pharmaceutical Technology
Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.
Jan 02, 2018
Pharmaceutical Technology
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
Jan 02, 2018
Pharmaceutical Technology
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
Jan 02, 2018
Pharmaceutical Technology
Process validation is an extension of biologics development processes.
Jan 02, 2018
Pharmaceutical Technology
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Jan 02, 2018
Pharmaceutical Technology
The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
Dec 28, 2017
By Pharmaceutical Technology Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
Dec 20, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
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