The Australian Pesticides and Veterinary Medicines Authority (APVMA) has established Good Manufacturing Practice (GMP) requirements to ensure the quality and safety of veterinary medicines. These guidelines outline a framework of best practices and quality standards that manufacturers must adhere to.
APVMA GMP Requirements
- Compliance with the Australian Code of GMP for APVMA products: All manufacturers are required to fully comply with this code, which details the specific GMP standards and expectations.
- Defined and Controlled Manufacturing Process: Every stage of the manufacturing process must be clearly outlined and controlled. This ensures consistency, adherence to specifications, and helps prevent errors or cross-contamination.
- Validation and Qualification Activities: Manufacturers must conduct thorough validation and qualification for each manufacturing process to demonstrate that it consistently produces a product meeting its predetermined specifications and quality attributes.
- Product Design and Development: Products should be designed and developed in a manner that meets the needs of the user and the intended patient population.
- Appropriate Facilities and Equipment: The facilities and equipment used in the manufacturing process should be fit for purpose, clean, and regularly maintained to ensure the continued production of high-quality products.
APVMA GMP Audits
To ensure compliance with these GMP requirements, the APVMA conducts regular audits of manufacturers. During these audits, manufacturers must be prepared to provide evidence of their compliance with GMP standards and their efforts to maintain and improve upon these standards over time.
The Australian Pesticides and Veterinary Medicine Authority (APVMA) is responsible for the assessment and registration of agricultural and veterinary chemical products proposed for supply and use within Australia. Our consultants have extensive experience in the regulatory requirements of the EU and US FDA as well as the Australian APVMA and we understand that the emphasis on pesticide registration should be risk based as well as cost effective.
This mindset allows new products to be introduced faster without jeopardising the product’s quality or safety.
Agricultural pesticides and veterinary chemical products in Australia are required to comply with the current Good Manufacturing Practice regulations published by the AVPMA in 2007.
We offer a full range of validation services to help you meet AVPMA compliance – from cleaning validation and process validation all the way to computer systems validation.
PharmOut offers GMP project management services to help you get from the initial idea all the way to getting production up and running in the new facility and complying with the relevant AVPMA regulations.
If you already have a facility design, we can provide an independent GMP review to make sure that all the important details are covered and nothing has been missed before the property lease is signed and the cement is poured.
Get help finding permanent or temporary staff with specific technical skills and experience.
If you have a regulatory audit coming up, make sure you are ready by having a pre-audit by one of our experienced consultants.
PharmOut offers a range of practical and effective GMP training courses that can be delivered online, onsite, or in a city near you.
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