Standards & Regulations

Sep 01, 2018
BioPharm International
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
Sep 01, 2018
BioPharm International
This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
Aug 29, 2018
By BioPharm International 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.
Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
May 14, 2018
By BioPharm International Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 14, 2018
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
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
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
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
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
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