Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
A basic tenet of GMP is that:
- quality cannot be tested into a batch of product
- quality must be built into each batch of product during all stages of the manufacturing process.
There are different codes of GMP, depending on the type of therapeutic good.
For details go to Manufacturing medicines.
- PageOverseas manufacturersSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
- PageAustralian manufacturersA step-by-step guide to assist Australian manufacturers of therapeutic goods apply for a Good Manufacturing Practice (GMP) licence.
- PageVary your GMP clearance or licenceVary your Good Manufacturing Practice (GMP) clearance or licence.
- PageComplying with the manufacturing principles for medicinesComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
- Good manufacturing practice - an overview
- Guidance on the management of GMP compliance signals
- Manufacturing principles for medicinal products
- Notices for manufacturers
- Data Management and Data Integrity (DMDI)
- Manufacture of sterile radiopharmaceuticals labelled with fluorine-18
- Medicinal gases guidance
Listed and complementary medicines
- Supplier assessment, approval and qualification for listed and complementary medicines
- Product Quality Reviews (PQRs) for listed and complementary medicines
- Compounded medicines and good manufacturing practice (GMP)
- GMP information for manufacturers of compounded medicines and DAAs
- Sampling and testing for listed and complementary medicines
- Ongoing stability testing for listed and complementary medicines
- Guidelines for sterility testing of therapeutic goods
- GMP clearance guidance
- Sponsor responsibilities related to GMP clearance and certification
- GMP Clearance questionnaire
- GMP Clearance code tables guidance
- Notices about GMP clearance
- GMP clearance - Extension application processing timeframes
- GMP Clearance code tables guidance - Manufacturing steps
- GMP Clearances: Timeframes for transfers and name change applications
- Clearance Application Assistance Tool