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.

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 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.

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.

Release for supply

Information about release for supply—including key differences with the release from manufacture process.

Performing release for supply

How manufactures can approach the release for supply process—including declarations of compliance and batch reviews.

Responsibilities in contract manufacture

The responsibilities of parties involved in contract manufacturing arrangements.

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