Department of Health and Human Services November 18, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Process Validation: General Principles and Practices.'' FDA is revising its guidance for industry entitled ``Guideline on General Principles of Process Validation,'' which issued in May 1987 (the 1987 guidance). The revised draft guidance promotes a ``lifecycle'' approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.