Validation and Compliance

Sep 12, 2013
By BioPharm International Editors
FDA updates guidance to reflect advances in technology.
Sep 01, 2013
BioPharm International
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Jul 02, 2013
By BioPharm International Editors
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
Jul 01, 2013
BioPharm International
Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.
Jul 01, 2013
BioPharm International
European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
Jun 01, 2013
BioPharm International
Companies can use metrics as a tool to help drive positive change and quality process improvements.
Jun 01, 2013
BioPharm International
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
Jun 01, 2013
BioPharm International
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
May 01, 2013
BioPharm International
By BioPharm International Editors
The author presents best practices for extractables and leachables.
May 01, 2013
BioPharm International
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
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