Contract manufacture

Some manufacturers decide to sub-contract particular steps of the veterinary chemical manufacturing process to other manufacturers – including laboratories.

This is often the case when a manufacturer has limited or no expertise in a particular manufacturing step such as labelling, packaging or product testing. They may choose to sub-contract those steps to other manufacturers with more expertise in that area, meaning many veterinary products in Australia are produced in multiple facilities.

Arrangements between parties involved in contract manufacture must not compromise the quality of the finished product. GMP agreements must be in place and must specify responsibilities – and accountability – of each party involved. The arrangements must also ensure that the activities being undertaken comply with the appropriate Code of Good Manufacturing Practice.

Complying with conditions

All manufacturers and laboratories involved in any step of manufacturing veterinary chemical products must be licensed and comply with conditions relating to manufacture.

Manufacturers must only sub-contract steps of the process to other facilities licensed by the Australian Pesticides and Veterinary Medicines Authority (APVMA) to perform that step. This is a condition of the licence to manufacture. It is also a condition on a product’s registration that the holder of the product must provide evidence that each step of manufacture complies with the appropriate standard – whether it occurs in Australia or overseas.

Where a manufacturer has been issued a licence by the APVMA in recognition of other accreditation held, it is a condition of the licence that all aspects of veterinary chemical manufacture are undertaken in accordance with Good Manufacturing Practice (GMP) using the same premises, plant and equipment, processes and procedures, documentation and personnel that are used in the manufacture of human therapeutics, as inspected and licensed by that other authority. Therefore, where a contract manufacturer holds a licence issued in recognition of other accreditation, the APVMA expects that they comply with the GMP requirements employed by the issuer of the recognised accreditation.

In exceptional circumstances, the APVMA can issue a permit that authorises the carrying out of a step of manufacture for a particular veterinary chemical product at a specified premises.

If a contract manufacturer or laboratory is located outside of Australia, it must comply with the requirements for overseas manufacturers. This means the APVMA has determined the overseas manufacturer or laboratory complies with a standard comparable to the APVMA’s Manufacturing Principles and Australian Code of GMP for Veterinary Chemical Products.

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