This content is current only at the time of printing. This document was printed on 16 October 2018. A current copy is located at https://apvma.gov.au/node/19636
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Responsibilities in contract manufacture
This includes the responsibility to provide appropriate information to other parties involved in the product’s manufacture. They also have responsibilities to comply with the Manufacturing Principles, including maintaining the appropriate licence or GMP compliance.
1. Providing product related information
Registrants may provide each sub-contractor (contract manufacturer) with copies of the relevant registration documents or a dated outline of the process being undertaken, along with product related information summaries. This information must be consistent with the application for product registration submitted to, and approved by, the APVMA.
Contract manufacturers should provide the person performing the final product’s release for supply—or the party conducting the next manufacturing step—with:
- a dated overall product statement
- an outline of the sub-contracting arrangements
- all necessary product-related information.
Registrants, or manufacturers, are generally able to provide other parties with product-related information, however any confidentiality restrictions may result in alternative arrangements being made between parties. If all necessary information cannot be provided to the person responsible for release from manufacture, a certificate or declaration of compliance should not be issued by the manufacturer.
Product-related information may include:
- the approved label
- raw material and product specifications
- packaging specifications
- manufacturing process control parameters
- test methods
- equipment and process validation in process control testing—and finished product testing.
2. Release from manufacture
Where the manufacture of veterinary products occurs in stages at different manufacturing sites, the authorised person at each site is responsible for releasing the bulk or intermediate for the next step of manufacture.
Each release should include a declaration of compliance that is consistent with the GMP Code clause 547 and address relevant product related information, codes and standards that apply to that part of the process. The release from manufacture step should include the same quality checks as release for supply, within the scope of the manufacturing steps undertaken.
The authorised person responsible for providing declarations of compliance must be able to demonstrate they have all the relevant information and technical capability necessary to perform this review step.
3. Licensing and overseas GMP compliance
Each Australian veterinary chemical manufacturer must be appropriately licensed by the APVMA.
This means all parties involved in producing intermediate products to release from manufacture or finished products to release for supply need to be licensed. The conditions on their licence must specify they can undertake that step for that product.
Overseas manufacturers must hold current GMP compliance and be recognised by the APVMA to perform the relevant steps of manufacture for the specific product.