federal_register: 2011-1437

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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
2011-1437 Guidance for Industry on Process Validation: General Principles and Practices; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Process Validation: General Principles and Practices." This guidance provides information for the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs). The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements. This guidance revises and replaces the guidance for industry entitled "Guideline on General Principles of Process Validation," dated May 1987. 2011-01-25 2011 1 https://www.federalregister.gov/documents/2011/01/25/2011-1437/guidance-for-industry-on-process-validation-general-principles-and-practices-availability https://www.govinfo.gov/content/pkg/FR-2011-01-25/pdf/2011-1437.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Process Validation: General Principles and Practices." This guidance provides information for the pharmaceutical industry on the elements of...  

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