Sterile Manufacturing

Good Manufacturing Practices (GMP) guidance’s and regulatory requirements for Sterile manufacturing, Aseptic processing, Sterilisation Process control and Process validation, Aseptic process simulation / Media fill, Container Closure Integrity, Sterility assurance, Product sterility testing, Medicinal products, Active substances (APIs), Excipients, Primary containers – USFDA, EUGMP, EMA, WHO, PICS, PDA, USP

• • USFDA : Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice – Guidance
  • USFDA : Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products – Guidance
  • USFDA : Sterilization Process Controls (Inspection)
  • USFDA: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
  • USP 1211: Sterilization And Sterility Assurance Of Compendial Articles (Access and read USP Chapter 1211))
  • Europe: Annexure 1, Manufacture of Sterile Medicinal Products (EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines)
  • EMA : Sterilisation of the medicinal product, active substance, excipient and primary container – Scientific guideline
  • PICS: Revised Annex 1 (Manufacture of Sterile Medicinal Products) /Guide to Good Manufacturing Practice for Medicinal products
  • PICS::Validation of Aseptic Processes (Jan 2011)
  • WHO: TRS 1044 – Annex 2: WHO good manufacturing practices for sterile pharmaceutical products (WHO Technical Report Series, No. 1044, 2022)
  • WHO: Good Manufacturing Practices For Sterile Pharmaceutical Products  (WHO Technical Report Series, No. 961, 2011)
  • ISPE : Validation of Aseptic Processes Using Media Fill
  • PDA Technical Report No. 22 (Revised 2011):  Process Simulation for Aseptically Filled Products
  • PDA Technical Report No. 28 Revised, (TR 28) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals (single user digital version)
  • ISO 13408-1:2008 :  Aseptic processing of health care products (Access to the documented is a paid service)
  • Useful Readings:
  • Product Sterility Testing . . . To Test or Not to Test? That Is the Question (Elaine Daniell; Trabue Bryans; Kimbrell Darnell; Joyce Hansen; Victoria M. Hitchins; Manuel Saavedra; Biomed Instrum Technol (2016) 50 (s3): 35–43)