FDA extends comment period on process validation guidance

The FDA has extended the comment period on the draft Guidance Document on process validations. The comment period now closes on March 16, 2009. The guidance comes from the following FDA Centers: CDER, CBER, and CVM. It does not cover medical devices, and therefore doesn’t replace the current Guideline on General Principles of Process Validation, dated May 1, 1987. You can view the draft guidance at http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA-2008-D-0559.