Compliance with the New Draft Guidance on Process Validation

FDA have released a draft Guidance document titled "Guidance for Industry - Process Validation: General Principles and Practices .The following categories of drugs are within the scope of this guidance: Human drugs Veterinary drugs Biological and biotechnology products Finished products and active pharmaceutical ingredients (API or drug substance)The drug constituent of a combination (drug and medical device) product The following categories of products are not covered by this guidance: Type A medicated articles and medicated feed Medical devices Dietary supplements Human tissues intended for transplantation regulated under section 361 of the Public Health

The draft guidance can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0559-gdl.pdf

Article - FDA's New Process Validation Guidance Recommends Team Approach

http://www.thephantomwriters.com/free_content/db/h/fda-process-validation-guidance.shtml

Webinar on this topic - http://www.ispe.org/cs/webcasts/process_validation