Quality Systems

Sep 28, 2015
By BioPharm International Editors
The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.
Sep 24, 2015
By BioPharm International Editors
US Compounding, Inc. issues voluntary recall of all sterile products.
Sep 22, 2015
In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.
Sep 21, 2015
By BioPharm International Editors
Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.
Sep 16, 2015
Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.
Sep 16, 2015
The White House nominates Robert Califf to head FDA, but will he be confirmed?
Sep 16, 2015
By BioPharm International Editors
The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
Sep 16, 2015
By BioPharm International Editors
FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.
Sep 15, 2015
BioPharm International
Manufacturers challenge details in new policies designed to promote access to important therapies.
Sep 10, 2015
By BioPharm International Editors
FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.
native1_300x100
lorem ipsum