Pharmaceutical lndustry Proposes Ideas for Number of Batches, Monitoring Production
This article was originally published in The Gold Sheet
The pharmaceutical industry is advancing ideas for estimating the number of batches to run during process validation as well as how to establish robust monitoring and testing programs for products on the market. Industry has been hammering out these details in the absence of many specifics in the FDA’s 2011 process validation guidance on these areas.
You may also be interested in...
ISPE Talks Process Validation: Managing CMOs, Figuring PPQ Batches
The pharmaceutical industry is proposing new approaches for managing validation activities of contract manufacturing organizations and for estimating the number of batches to run during process validation.
Industry Group Exploring Number of Batches for Early Stage Validation
An upcoming ISPE discussion paper aims to help manufacturers decide on the correct number of batches to run to demonstrate that a process is in a state of control in early stage validation studies.
CPV Shines New Light on Old Manufacturing Processes
Biopharmaceutical manufacturers say that implementation of continued process verification has helped to update “archaic” manufacturing processes for legacy products and uncover problems with raw materials. They have reaped some business benefits as well.