OR WAIT null SECS
April 02, 2017
Industry fears limited benefits as FDA readies voluntary data tracking program.
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
April 01, 2017
Continuous manufacturing will not work for all pharmaceuticals, but the right infrastructure, senior management support, and planning from the earliest stages of drug development could eventually allow up to 80-90% of small-molecule APIs to be made continuously, says Paul Sharratt, head of process science and modeling at Singapore’s Institute of Chemical and Engineering Sciences.
March 24, 2017
The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs
March 21, 2017
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
March 16, 2017
FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
March 15, 2017
An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
March 09, 2017
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.