This content is current only at the time of printing. This document was printed on 26 March 2019. A current copy is located at https://apvma.gov.au/node/72
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Good Manufacturing Practice (GMP)
Manufacturers of veterinary chemical products in Australia must comply with Good Manufacturing Practice (GMP).
GMP ensures veterinary chemical products are consistently manufactured to the appropriate quality standards for their intended use—and in accordance with their registration particulars and specifications. It encompasses both the manufacturing process and quality control activities and processes to ensure they comply with the GMP Code.
1. What is GMP?
Good Manufacturing Practice (GMP) for veterinary chemical products is about making sure the products supplied in Australia are safe, reliable and effective for their intended purposes.
Manufacturers can achieve this by using consistent manufacturing processes—under adequate supervision—with an effective quality control process.
Whether a veterinary chemical product supplied in Australia is manufactured locally or overseas, the Agvet Code requires every step of manufacture to meet a certain standard. It also requires manufacturers to use an effective quality control system to confirm their intermediate or finished products continue to meet that standard, before being released from manufacture or released for final supply.
2. GMP for Australian manufacturers
Compliance in Australia is monitored via GMP audits, conducted by external APVMA-authorised auditors. Auditors are recruited based on their experience, qualifications and familiarity with the Manufacturing Principles and the GMP Code. We also conduct training workshops and joint audits and, on occasion, send APVMA staff to audits, as observers.
3. GMP for overseas manufacturers
The APVMA operates an Overseas GMP Scheme for overseas manufacturers of veterinary chemical products supplied to Australia.
The APVMA assesses overseas sites’ GMP compliance at the point of product registration and as an ongoing activity over the life of the product.
Under this scheme, overseas manufacturers need to prove they meet GMP standards equal to those applied to manufacturers in Australia. The APVMA assesses overseas sites’ GMP compliance as part of the registration process and as an ongoing compliance activity over the life of the product.