This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/node/19631
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Performing release for supply
Performing release for supply of veterinary chemical products can be undertaken in a variety of ways—depending on how and where the product is produced.
Manufacturers performing release for supply are responsible for deciding what evidence they will accept from those performing earlier steps of manufacture.
Manufacturers performing release for supply are responsible for deciding how they will manage the process and what evidence they will accept from those performing earlier steps of manufacture. The party releasing the product to the market is ultimately responsible for the product. They need to be confident every step has been carried out in line with the manufacturing requirements.?
1. Managing release for supply
The APVMA does not stipulate how the party releasing the final product should manage their release for supply process.
Manufacturers may wish to seek guidance from other recognised Australian and overseas bodies for other ways to manage the release for supply process. The manufacturer performing release for supply needs to ensure whatever process they use, they can be confident all steps in the process meet the manufacturing requirements.
2. Declaration of compliance
Manufacturers can perform release for supply on the basis of declarations of compliance.
This means the party performing the final release can accept declarations of compliance from parties performing earlier steps of manufacture. This is often the case when it is impractical for the contract manufacturer performing the final release to comprehensively review every record from every manufacturer preceding them in the process.
The person authorised to perform release for supply must check declarations of compliance for accuracy and appropriateness against the overall product statements.
3. Batch and record reviews
Manufacturers conducting release for supply can opt to undertake a comprehensive review of all batch and related records from those performing earlier manufacturing steps.
This allows the person performing the release to access to all records relating to the product’s manufacture—for each step before them in the manufacturing process. They can then review the records to ensure:
- all necessary procedures have been followed
- all equipment is properly calibrated
- all raw materials—including packaging—as well as the intermediate and finished product comply with the appropriate specifications.
4. Conditions on release for supply
The person performing release for supply can only rely on decisions by other sub-contractor authorised persons to release intermediate, bulk or finished product if the following conditions are met:
- all partial manufacturers in the manufacturing chain are covered by valid GMP agreements which comply with the APVMA’s Manufacturing Principles and GMP Code (refer to the APVMA GMP Code Chapter 9 and also to PIC/S Guide to GMP) – these agreements should specify the release to the next manufacturer or release for supply
- authorised persons at each site of manufacture are provided with full access to all related parts of the registration details of the product for the steps of manufacture performed at the site
- all manufacturers have a document which outlines details regarding the release process for the relevant manufacture performed
- all decisions to release to the next step of manufacture or release for supply are documented in accordance with GMP requirements
- the authorised person performing release for supply of the finished product batch has accepted the quality management system used for partial release or release to the next step of manufacture, eg through a supplier audit – qualification, questionnaire and/or through the provision of requested information.
The person performing release for supply is ultimately responsible to ensure the above conditions are met when relying on other party’s compliance declaration and release decisions.