This content is current only at the time of printing. This document was printed on 12 September 2020. A current copy is located at http://www.xlg888.com/node/907
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Providing evidence of good manufacturing practice (GMP)
This is a guideline about the types of good manufacturing practice (GMP) evidence that you should submit when making an application to register, or vary the particulars of registration of, a veterinary chemical product.
The GMP evidence that is submitted to the APVMA for assessment is used to confirm that the manufacturing facilities responsible for the manufacture of veterinary chemical products are compliant with the Manufacturing Principles and the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products (GMP Code). Some manufacturers and product types are considered exempt from GMP licensing provisions under Part?7 of the Agvet Code Regulations.
As part of this regulatory framework, the APVMA operates two programs that monitor industry compliance with these requirements:
- the Manufacturers’ Licensing Scheme for veterinary products manufactured in Australia (Part 8 of the Agvet Code). The Agvet Code requires anyone carrying out a step in the manufacture (including finished product testing, release for supply, etc.) of a veterinary chemical product at premises in Australia to be appropriately licensed by the APVMA (unless a relevant exception applies)
- the Overseas GMP Scheme for veterinary products manufactured overseas.
The APVMA does not currently require registration holders to submit GMP evidence for active pharmaceutical ingredients used to manufacture veterinary medicines. However, where a product is comprised of 100 per cent active constituents (commercially available as a raw material) and the product undergoes any other steps of manufacture (for example, filling, final packaging, labelling, testing of finished product and release for supply), then evidence of licensing or approval of the manufacturer is required. Evidence of GMP compliance is also required where the active constituent is an intermediate product (for example, pre-blend or vaccine antigen). Evidence of GMP is not required for listed, reserved or exempt products such as agricultural chemical products.
How to prepare information about manufacturers
At the time of making an application to register a new veterinary chemical product or to vary the particulars or conditions of registration of a veterinary chemical product, you should provide evidence that all proposed manufacturing sites are licensed, or supply evidence of GMP compliance for overseas sites. The evidence should demonstrate to the APVMA that the manufacturer carrying out any manufacturing steps has been assessed (audited) by an appropriate recognised regulatory body and has an appropriate and effective quality management system in place.
We strongly encourage you to make sure that you hold acceptable evidence of GMP prior to applying for registration, as the process to obtain GMP evidence may be lengthy. We cannot grant the application and register the product until acceptable GMP evidence is submitted within the specified timeframe.
You may apply for pre-application assistance to discuss the GMP requirements associated with your application.
Types of GMP evidence accepted for registration of veterinary chemical products
Evidence of GMP for veterinary products manufactured in Australia
For veterinary products manufactured in Australia that require evidence of GMP, an APVMA licence is the only evidence that we will accept. For details on how to obtain relevant details or a copy of the licence, refer to the Manufacturers’ Licensing Scheme information.
At the time of making an application, you should confirm that all Australian manufacturing sites nominated are appropriately licensed to carry out the steps of manufacture at the particular premises for the proposed product type for which you are seeking registration. For example, a site that is licensed for non-sterile solid dosage forms only cannot carry out manufacture of sterile liquids.
You do not need to provide a copy of the APVMA licence with your application; however, you should provide the following information:
- the company name and street address of all manufacturing sites (this information should match the details on the licence exactly)
- the steps of manufacture of the product carried out by each manufacturer, including those performing testing and release for supply
- the APVMA licence number.
We will check the details provided against the issued licence to make sure that the nominated manufacturing facility (or facilities) is appropriately licensed for the manufacturing steps of the proposed product type and dosage form.
Evidence of GMP for veterinary products manufactured overseas
We carry out an assessment of overseas GMP evidence as part of the application process. The evidence we require is usually an official and current certification from the relevant agency in the country of export, provided that the agency’s certificates are recognised by the APVMA.
If you are seeking to register, or vary the particulars of registration of, a veterinary chemical product manufactured overseas, you must supply satisfactory evidence of the product being manufactured to a standard comparable to the Manufacturing Principles and the GMP Code.
Where the expiry period on the evidence of GMP is less than the timeframe for evaluation, you must provide an updated certificate before your application can be finalised.
Where acceptable GMP evidence of an overseas manufacturer is not available, we usually require the overseas site to undergo an audit by an APVMA-authorised auditor to assess GMP compliance. The scope of the audit is often limited to the manufacture of specific products of interest to the commissioning applicant/registrant. After completion of the APVMA audit, we send a confirmation letter to whoever commissioned the audit advising of them of the outcome. This confirmation letter is specific to whoever commissioned the audit and product types assessed. If a request is made by another applicant to consider the audit report on file, we will request written consent from the owner of the audit, so that auditor can confirm whether the manufacture of the proposed products was included within the scope of the recent audit.