Quality Systems

Sep 02, 2018
Pharmaceutical Technology
Sharing know-how can help resolve common bio/pharma technical challenges.
Sep 01, 2018
Pharmaceutical Technology
Sample preparation—specifically, API extraction and dilution—can introduce errors. Use of best practices and automation can reduce variability.
Sep 01, 2018
Pharmaceutical Technology
Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
Sep 01, 2018
Pharmaceutical Technology
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
Aug 29, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
Aug 28, 2018
By Pharmaceutical Technology Editors
Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.
Aug 28, 2018
By Pharmaceutical Technology Editors
The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.
Aug 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
Aug 27, 2018
By Pharmaceutical Technology Editors
FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.
Aug 24, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
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