FDA issues new draft Guidance Document for Process Validation

The FDA issued a draft Guidance Document on process validation for comments and suggestions. The comment period closes Jan. 21, 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 You can view the draft guidance at http://www.fda.gov/CDER/GUIDANCE/8019dft.pdf.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.