This content is current only at the time of printing. This document was printed on 19 October 2018. A current copy is located at https://apvma.gov.au/node/19626
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Release for supply
Release for supply is the process of ensuring a batch of finished veterinary chemical product meets all required quality standards and is suitable to be released for sale.
Release for supply is a step of manufacture involving a comprehensive review of batch and related records to ensure all necessary procedures have been followed, all equipment is correctly calibrated and all raw materials (including packaging), intermediate and finished product comply with specifications.
The release for supply process helps ensure quality, safety and efficacy of the finished product.
Single-site and multi-site manufacturers
In cases where all steps of manufacture are conducted on a single site operated by the registrant, performing release for supply is relatively straight forward. The person conducting the release has ready access to all the relevant particulars in the application for product registration. They also have ready access to all batch manufacturing and supportive quality assurance records—including equipment and process validation.
When the manufacturing process is fragmented across a number of distinct sites under contract manufacture arrangements, there are more parties—and records—involved. In such cases it can be impractical for the person performing the release to review every related record from every step in the process. For this reason they may wish to consider declarations of compliance from some or all manufacturers before them in the chain.
GMP agreements in contract manufacture
It is essential to have a GMP agreement is in place between parties involved in the contract manufacturer of veterinary chemical products.
The GMP agreement must clearly:
- define the responsibility of parties
- stipulate the responsibility of the provider of bulk, intermediate or unfinished product to notify the recipients of any:
- significant process deviations
- change controls
- out of specification results
- complaints or other matters which should be taken into account by the person who is responsible for release for supply of the finished product batch
- state who is responsible for recall and recall management
- list the type of documents required to ensure the person conducting release for supply has access to the required documentation.
Those performing release for supply in Australia must hold an APVMA GMP licence. The GMP licence must be for the relevant product category and specifically permit the manufacturer to perform release for supply.
Ultimately, the person performing the release for supply—the authorised person—is responsible for the product. They must be satisfied any record or declaration of compliance they rely on is accurate—and appropriate—for the product based on information provided by the registrant.
Release from manufacture
Release for supply is different from release from manufacture as they are undertaken at different times in the manufacturing process.
Release from manufacture is conducted at earlier steps in the contract manufacturing process—whereas release for supply is the final step. While these processes occur at different times, they both involve a review to confirm all necessary procedures have been followed, the equipment is correctly calibrated and all raw materials (including packaging) and intermediate product comply with specifications.