federal_register: E8-27321

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E8-27321 Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Process Validation: General Principles and Practices."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 The revised draft guidance promotes a "lifecycle" approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance. 2008-11-18 2008 11 https://www.federalregister.gov/documents/2008/11/18/E8-27321/draft-guidance-for-industry-on-process-validation-general-principles-and-practices-availability https://www.govinfo.gov/content/pkg/FR-2008-11-18/pdf/E8-27321.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Process Validation: General Principles and Practices."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...  

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