GMPs

May 02, 2017
Pharmaceutical Technology
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
Apr 20, 2017
By Pharmaceutical Technology Editors
The agency is warning about the potential threat of respiratory depression in children who take medicines with codeine or tramadol.
Apr 18, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
Pharmaceutical Technology spoke with Brad Pedrow and Rajesh Singh of Deloitte Consulting to discuss serialization implementation, and what to expect as the DSCSA deadline approaches.
Apr 14, 2017
By Pharmaceutical Technology Editors
Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Nighttime Baby Teething Tablets due to inconsistent amounts of belladonna alkaloids.
Apr 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
Apr 12, 2017
By Pharmaceutical Technology Editors
The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.
Apr 12, 2017
By Pharmaceutical Technology Editors
The agency cited the company’s India facility for batch failures and data integrity problems.
Apr 02, 2017
Pharmaceutical Technology
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
Apr 02, 2017
Pharmaceutical Technology
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 02, 2017
Pharmaceutical Technology
Industry fears limited benefits as FDA readies voluntary data tracking program.
native1_300x100
lorem ipsum