Regulatory/GMP Compliance

Sep 02, 2018
Pharmaceutical Technology
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
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 30, 2018
By Pharmaceutical Technology Editors
The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
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 28, 2018
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
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.
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