Hi to Everyone.

I’m going to start with the process validation of our product using the full scale batch size.

Which is the range for the batch size the 20 % is acceptable, or less.
There is a official document issued by Fda or other Moh in where is defined the range .
Do you also have information on this issue?


Thank you for you support.

A quick search of the forum brought up these documents:

FDA releases new Draft Guidance - Process Validation - Gen Principles and Practices (http://elsmar.com/Forums/showthread.php?t=31041)

IQ, OQ, PQ and Validation Master List (http://elsmar.com/Forums/showthread.php?t=31962)

Understanding FDA requirements for Software Validation (http://elsmar.com/Forums/showthread.php?t=29299)

Might help....

may be the context is a little different here... covering the post approval changes ..etc.,but it helps us in providing the general regulatory bodies approach in handling variance of production/process parameters is covered under SUPAC guidelines.

the guidelines specifies the supporting activities to carried out for the specified variance in process/production parameters.

you can refer to the Sec.V. CHANGES IN BATCH SIZE (SCALE-UP/SCALE-DOWN);
http://www.fda.gov/cder/guidance/cmc5.pdf



hope that relevant & helps.

valiveti.