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.
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PageSponsors can apply for Good Manufacturing Practice (GMP) clearance or certification for their overseas manufacturers.
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PageA step-by-step guide to assist Australian manufacturers of therapeutic goods apply for a Good Manufacturing Practice (GMP) licence.
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PageVary your Good Manufacturing Practice (GMP) clearance or licence.
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PageComplying with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Manufacturing Practice (GMP).
More information
- 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
- Compounded medicines and good manufacturing practice (GMP)
- GMP information for manufacturers of compounded medicines and DAAs
Testing
- Sampling and testing for listed and complementary medicines
- Ongoing stability testing for listed and complementary medicines
- Guidelines for sterility testing of therapeutic goods
Clearance
Topics