Quality Control/Quality Assurance

May 17, 2018
By BioPharm International Editors
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
May 17, 2018
By BioPharm International Editors
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
May 16, 2018
By BioPharm International Editors
The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.
May 16, 2018
By BioPharm International Editors
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
May 14, 2018
By BioPharm International Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 01, 2018
BioPharm International
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.
May 01, 2018
BioPharm International
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
May 01, 2018
BioPharm International
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
Apr 30, 2018
By BioPharm International Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 30, 2018
By BioPharm International Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
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