Manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals (excluding class 1 biologicals), blood and blood components and haematopoietic progenitor cells have responsibilities in relation to:
- during manufacture
- informing the TGA
- licence-specific responsibilities
- GMP inspections
- post-inspection responsibilities.
For Australian manufacturers with licences, many of these responsibilities are legal requirements in the Therapeutic Goods Act 1989- external site and the Therapeutic Goods Regulations 1990- external site. Section 40 of the Therapeutic Goods Act 1989 and Regulations 19 and 20 contain conditions for licence holders.
For overseas manufacturers the same responsibilities and expectations apply, unless otherwise specified.
Key information for industry
- PageGood manufacturing practice (GMP)Information on complying with good manufacturing practice (GMP).
- PageRecord keeping requirements for manufacturers of medicinesUnderstand your record keeping responsibilities.
- PageComply with state, territory and other requirementsComply with state, territory and other requirements for manufacturing medicines.
More information
- Good manufacturing practice application decision tree
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Australian manufacturing licences and overseas GMP certification
- Update to Manufacturing Principles for medicines, APIs & sunscreens
- Release for supply of medicines
- Guidance for TGO 101
- Guidelines for sterility testing of therapeutic goods
- Clearance Application Assistance Tool
TGA Industry Working Group on GMP meetings
Publications
- Code tables
- Process validation for listed and complementary medicines
- Releasing medicines manufactured at multiple sites
Presentations
- Webinar presentation: Remote Inspections from TGA Manufacturing Quality Perspective
- Webinar presentation: Management of GMP compliance signals
- Webinar presentation: GMP inspection trends for non-sterile registered medicines
- Webinar presentation: Regulation in times of a pandemic
- Webinar presentation: Overview of GMP regulatory activities
- Webinar presentation: Inspection reliance
- Webinar presentation: Remote GMP inspections: Current feedback and future considerations
- Webinar presentation: Clean room requirements for biologicals
- Webinar presentation: Code tables for GMP Clearances
- Webinar presentation: GMP overview and an update on PIC/S guide to GMP for medicinal products version 14
- Webinar presentation: How to improve your GMP compliance for listed medicines and GMP implementation of TGOs 92 and 101
- Webinar presentation: GMP licence applications
- Webinar presentation: GMP clearance - Common deficiencies
- Webinar presentation: Sterile medicines - lessons from StrugglePharm
- Webinar presentation: Manufacturing investigational medicinal products
- TGA presentations: Good Manufacturing Practice (GMP) Forum 2021, Online, 12-14 May 2021
- Presentation: Good manufacturing practice inspections during the pandemic - an Australian perspective
Topics
Latest articles
- NoticesGMP Clearance: Extension processing timesDelays in processing timeframes of applications to extend GMP Clearances.
- NoticesGMP Clearance: Additional countries added to MRA pathwayMore applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.
- NoticesUpdate to the Manufacturing Principles for medicines, APIs & sunscreensUpdate to the manufacturing principles for medicinal products
Latest publications
- PublicationsManufacturing principles for medicinal productsPIC/S Guide to Good Manufacturing Practice for Medicinal Products
- PublicationsManufacturing Quality Branch annual reportsThe TGA has published insights into recalls and GMP regulation for 2019-20.
- PublicationsReleasing medicines manufactured at multiple sitesGuidance for sponsors or manufacturers of a medicine across multiple sites