Search results for "validation"
Article
Understanding Validation and Technical Transfer, Part I
Process validation is documented process understanding and control that begins when it is determined that a cell, molecule, or compound may have clinical significance and ends when the product is no l…
Article
Challenges in Analytical Method Development and Validation
The development and validation of analytical methods is crucial in drug development. While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technolo…
Article
PDA's Technical Report for Biotech Cleaning Validation
49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, Destin A. LeBlanc
ABSTRACT
Quality by Design principles such as design spac…
Article
The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compl…
Article
Understanding Validation and Technical Transfer, Part 3
When correctly done, linking process to product to patient, validation ensures safe and effective drug and biologic products and benefits the patients whose health and wellbeing depend on them.
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Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…ered and that, based on the level of risk, cleaning processes may be subject to different levels of validation or verification.
This article covers cleaning validation of equipment dedicated to t…
Article
Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
Article
Understanding Validation and Technical Transfer, Part 2
The intent is to think outside the box and avoid terminology traps that hinder many validation efforts.
Part 1 of this series, which appeared in the April 2018 issue of this publication, conta…
Article
Design of Experiments for Analytical Method Development and Validation
DOE for analytical methods has three major applications: method development for new methods or those that need improvement, method validation, and quantitation of the influence of analytical methods o…
Article
ISPE Releases Cleaning Validation Guide
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitione…