Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Pharmaceutical lndustry Proposes Ideas for Number of Batches, Monitoring Production

This article was originally published in The Gold Sheet

Executive Summary

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.

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts