Guidance for industry [[electronic resource] ] : sterile drug products produced by aseptic processing, current good manufacturing practice

• Record Nr.: UNINA9910699115303321
• Pubbl/distr/stampa: Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004]
• Descrizione fisica: 1 online resource (59 pages)
• Soggetti: Drugs - Sterilization - United States; Asepsis and antisepsis
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: "Center for Biologics Evaluation and Research (CBER)."; "Office of Regulatory Affairs (ORA)."; "Pharmaceutical CGMPs."; "September 2004."
• Nota di bibliografia: Includes bibliographical references (pages 54-55).