This content is current only at the time of printing. This document was printed on 22 February 2017. A current copy is located at http://apvma.gov.au/node/1106
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Responsibilities of manufacturers
1. Complying with GMP in Australia
Veterinary chemical product manufacturers in Australia are required to be licensed by the APVMA and are responsible for complying with the Agvet Code and the GMP Code. Registrants of imported products are required to maintain appropriate evidence of the overseas sites GMP compliance. Overseas manufacturers of products imported into Australia are responsible for ensuring they comply with GMP standards equivalent to Australian standards.
This means manufacturers need to ensure every step of the manufacturing process they undertake meets the legal requirements and that appropriate records are maintained as evidence of their ongoing compliance. They must also ensure these records are made available to the APVMA and to APVMA-authorised auditors on request, or to other manufacturers, if their product is produced under contract manufacture arrangements.
The Agvet Code prescribes penalties for offences relating to noncompliance by Australian manufacturers with licensing provisions and conditions. Penalties include the imposition of restrictive licence conditions and the suspension and cancellation of licences. The Agvet Code also provides regulatory tools that allow us to monitor manufacturing activities and investigate suspected noncompliance.
2. Quality assurance
Manufacturers of veterinary chemical products are responsible for ensuring appropriate quality assurance and quality control activities are undertaken during their steps of manufacture.
Manufacturers are also responsible for actively maintaining their quality management system to ensure it is effective, relevant and appropriate for the product and its level of risk. The system must be fully documented, regularly monitored for effectiveness and allow for identifying opportunities for continuous improvement.
3. Responsibilities of key persons
The Agvet Code regulations, the Manufacturing Principles and the GMP Code outline specific responsibilities for the key persons nominated by the licence holder and listed in APVMA records as being responsible for controlling production and quality.
Under Agvet Code Regulations, it is a condition of the licence that the key people maintain their control of production and quality. If a key person is replaced, the licence holder must advise the APVMA of the name, qualifications and experience of their replacement.
4. Variations to a licence or its conditions
Licensed Australian manufacturers of veterinary chemical products are responsible for notifying the APVMA of any changes or variations that may affect their licence or its conditions. This can apply to changes in the product (types), the manufacturing site and processes or to key persons.
Manufacturers are responsible for having a system in place to recall a product after it has been supplied to the market and for implementing that system, when required.
Recall action can be instigated by the manufacturer, registrant or the APVMA when:
- a product represents a risk to Australia's trade or the safety of people, animals or the environment
- there are concerns about the efficacy of the product
- stocks or a particular batch of a registered chemical product do not conform with the details recorded in the chemicals database.
The APVMA has published recall guidelines to provide more details on responsibilities of manufacturers and other parties when undertaking recalls.