GMPs

May 02, 2016
Pharmaceutical Technology
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
Apr 18, 2016
By Pharmaceutical Technology Editors
The agency published guidance on data integrity as it is relates to CGMP compliance.
Apr 02, 2016
Pharmaceutical Technology
A global API marketplace increases the burden of supply chain monitoring for drug companies.
Apr 01, 2016
Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.
Mar 16, 2016
Equipment and Processing Report
Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
Mar 02, 2016
Pharmaceutical Technology
Data integrity is a widespread, global problem that must be addressed.
Mar 02, 2016
Pharmaceutical Technology
Siegfried Schmitt, principal consultant, PAREXEL, discusses the regulatory requirements for CGMPs in the different phases of drug development and manufacture.
Feb 12, 2016
By Pharmaceutical Technology Editors
Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.
Jan 21, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.
Jan 01, 2016
Pharmaceutical Technology
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
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