Seeking stakeholder input into guidance on managing release for supply of contract manufactured veterinary medicines

Submissions are invited from interested stakeholders on the development of guidance for industry on managing release for supply of contract manufactured veterinary medicines.

Background

‘Release for supply’ is a step in manufacture that involves a comprehensive review of batch and related records to ensure that all the necessary procedures have been followed, all the equipment calibrated, and all raw materials (including packaging), intermediate and finished product complies with specifications. The process of conducting release for supply can be logistically challenging, when the manufacturing process is fragmented across different geographic locations. The guiding principle is that—the arrangements for contract manufacture must not compromise the quality of the finished product (APVMA Manufacturing Principle 14 (2)). This and other relevant requirements have not changed.

Discussion paper

We have developed a discussion paper which describes proposed options for managing release for supply for contract manufactured veterinary medicines. The intention of the proposed guidance is to provide both manufacturers and registrants with flexibility when manufacture is fragmented across sites in different locations.

The discussion paper considers:

• current requirements and responsibilities of the parties involved
• options for conducting ‘release for supply
• the types of documents required to support release for supply

Consultation information

The APVMA is seeking feedback in relation to the discussion paper to ensure the proposed guidance provides clear information to assist manufacturers and registrants.

The APVMA invites comments on the discussion paper. In preparing your submissions you may wish to consider the following questions:

• Do you have any comments on the proposed approach to ‘release for supply’?
• Do you consider that there will be any unintended consequences of the proposed guidance?
• Do you have any suggestions for improving the proposed approach?
• Do you have any comments on conditions which may need to be added to APVMA licences in relation to the proposal?
• Do you consider that a transitional period is necessary for implementation of the proposal?

The consultation period is open until close of business on Friday 21 August 2015. All submissions will be published unless you state in your submission that you do not want the submission to be published.

Following consideration of comments the policy will be finalised as a guideline and made available on the APVMA website before 1 January 2016.

Please email your submissions to mls@apvma.gov.au.

Hardcopy submissions can be posted to:

Manufacturing Quality and Licensing
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604