TGA Mandatory Enforcement of PE-009-08 Annex 1 Sterile Products July 2
Mon, Apr 19 2010

• TGA announces enforcement of the PIC's EUGMP Annex 1 update Feb 2008
• TGA Expectations from July 2010 "The manufacturer has incorporated new and changed requirements for sterile manufacture"
• Continuous Particle Monitoring required in Grade A Environments
• Requirement to monitor Transfer Tunnels
• Transfer of Freeze Dried Products
• Crimping & Capping Equipment
• Need to upgrade your monitoring requirements ?
• Talk to us we will guide your through the new regulations with ease

• Want to learn more then contact our Cleanroom Monitoring Specialist for more information regarding TGA expectations or download our latest Newsletter below

  • Kenelec Scientific Headquarters
    23 Redland Drive, Mitcham, VIC, Australia 3132
    Ph: +61 3 9873 1022
    Fax: +61 3 9873 0200
  • National Freecall No.
    1300 73 2233
  • Kenelec Scientific NSW
    Suite 206, 10 Norwest Central Century Circuit
    Baulkham Hills NSW Australia 2153
    Ph: +61 2 8831 8366
    Fax: +61 2 8831 8399