Process Validation

Nov 02, 2016
Pharmaceutical Technology
A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.
Nov 02, 2016
Pharmaceutical Technology
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
Aug 02, 2016
Pharmaceutical Technology
Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.
Aug 01, 2016
Pharmaceutical Technology
The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \
Jul 19, 2016
By Pharmaceutical Technology Editors
FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.
Jun 02, 2016
Pharmaceutical Technology
This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
Jun 02, 2016
Pharmaceutical Technology
Experts discuss the key considerations in the development of an autoinjector.
Apr 25, 2016
By Pharmaceutical Technology Editors
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
Apr 02, 2016
Pharmaceutical Technology
Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.
Jan 02, 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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