The discovery, development, testing and manufacture of therapeutic products is covered by a variety of codes of Good Practice and associated standards.
In Australia, certification and accreditation for each standard is managed by various regulatory and accrediting agencies.
Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health studies are performed. . It represents a set of principles providing a quality framework within which R&D activities are planned and undertaken, including reporting and archiving of data. The GLP principles help assure regulatory and accrediting bodies that data submitted by laboratories are reliable and reproducible for the purposes of making safety and risk assessments relevant to therapeutic products.
OECD-produced documents for GLP are located here.
This is an international quality standard for laboratory research that describes the specific requirements laboratories must satisfy to demonstrate that they:
Click here for more information on ISO/IEC17025.
A well-known and widely used standard, ISO9001 sets out the general requirements of a quality system. This standard is based on a number of quality management principles including a strong customer focus, the motivation andimplication of senior management, the approaches used to refine process and continual improvement of products and services.
This series of standards relates specifically to cleanrooms and associated controlled environments.
The code of Good Manufacturing Practice (GMP) includes principles and procedures that should be followed during production of therapeutic goods. These principles ensure the quality and consistency of each batch of product at all stages of production. There are different codes of GMP for production of pharmaceuticals and production of biological material.
Facilities can be certified as GMP-compliant by the Therapeutic Goods Administration usually following an on-site inspection.
Click here for more information on TGA inspections.
GCP is an international quality standard that is laid down by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The GCP standard contains ethical and procedural details for the safe running of clinical trials, including tests on human subjects.
In Australia, the Therapeutic Goods Administration has adopted the European version of the GCP guidelines.
While GCP guidelines are recognised and adopted by the TGA, there is currently no formal accreditation process.
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