APVMA Code of GMP (Veterinary Medicines)

Description

APVMA Code of GMP for Veterinary Medicines and Pesticides (Australia)

This course provides a structured learning pathway to enhance GMP compliance knowledge in veterinary medicines and pesticide manufacturing in Australia, as overseen by the APVMA.

• The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the national regulatory authority for these medicinal products, chemicals and pesticides in Australia.
• Australian veterinary chemical products (including pesticides) must meet the Good Manufacturing Practice (GMP) requirements outlined in the Australian Pesticides and Veterinary Medicines Authority (APVMA) Code of GMP.
• The APVMA’s GMP Code has notable differences compared to PIC/S GMP guidance, referenced by many other regulatory authorities around the globe.

This GMP training module by PharmOut Pty Ltd provides interactive GMP compliance content for the APVMA GMP rules, delivered in an eLearning format (online training format). It includes quick quizzes to aid GMP compliance knowledge retention. Completion of the course’s online Final Assessment will provide learners with a GMP Course Certificate of Completion for this education topic.

GMP Compliance with APVMA Rules

Veterinary Medicines: Australia’s GMP Regulations

The APVMA Code of GMP is based on the following Australian legislation:

• The Agricultural and Veterinary Chemicals (Administration) Act 1992
• The Agricultural and Veterinary Chemicals Code Act 1994

Applicability of the APVMA Code of GMP

• Veterinary medicines and chemicals made or imported into Australia (as well as exports) must meet the APVMA’s GMP Code.
• It is recommended that this course be completed along with the Good Laboratory Practice (GLP) course, and other product-relevant GMP education where relevant.

Compliance Essentials for APVMA Code of GMP

• The APVMA GMP code applies to veterinary medicines and AgVet chemical products being manufactured, used, or exported from Australia.
• This APVMA Code of GMP (Compliance eLearning course/Certificate GMP Course) covers industry requirements for manufacturing and distributing veterinary chemical products and pesticides, up to the point of retail sale.
• The compliance topics introduced in this online course can enhance your compliance knowledge and help your company meet the requirements listed in the APVMA Code of GMP.

Other regulations that apply

If you manufacture or distribute products in other regions, you will need to learn and comply with their specific laws.

• For example, many countries refer to PIC/S GMP guidance for the manufacture of therapeutic goods, including veterinary medicines; e.g. PIC/S Annexes 4 and 5.
• In the European Union (EU), the Eudralex describes GMP requirements in Chapter 4.
• The GMP code for veterinary medicines & other AgVet chemical products manufactured, used in, and/or exported from Australia, is published by the regulator (APVMA not TGA).

In Australia, veterinary medicines (veterinary chemical products) must meet the APVMA’s GMP code, which has differences compared to PIC/S GMP guidance.

Key Learning Topics

APVMA Code of GMP: Compliance Training Course

This course introduces the APVMA GMP compliance rules relevant to the following GMP compliance topics for veterinary chemical products (including pesticides & AgVet products).

In this course, you’ll learn what the APVMA and other industry stakeholders expect in terms of:

✅ Building, Facilities, and Workflows
✅ Personnel Roles & Responsibilities
✅ Quality Management System (QMS) Implementation
✅ Internal Audits/QMS Reviews
✅ Personnel Training Requirements, including Health & Hygiene
✅ Quality Assurance & Quality Control Expectations
✅ Production, Material Management, Packaging/Labelling, and Product Storage
✅ Environmental Monitoring
✅ Outsourcing (Contract Manufacturing)
✅ Sampling Plans & Sample Retention Periods
✅ Batch Recordkeeping & Product Release Procedures
✅ Complaints and Recalls
✅ Validation & Qualification

Course content is relevant to the 11 core chapters of the APVMA Code of GMP.

What about PIC/S Annexes 4 and 5 and other Annexes for veterinary products?

While this online GMP Compliance Training course excludes product-specific PIC/S Annexes that may be relevant to your veterinary medicines/product lines, individual courses for PIC/S GMP education topics are available from our online GMP training store (click the ‘store’ menu or ‘all courses’ menu item).

Scope of GMP Code for Australian Veterinary Medicines

Registration

• Veterinary medicines & chemical products must be registered with the APVMA before they can be manufactured, imported, exported or distributed in Australia.
• Click here for APVMA product registration information, click here.

GMP compliance

APVMA Excerpt: “Agricultural and veterinary chemical products must be shown to work, be safe for people, animals, plants and the environment, and not unduly jeopardise Australia’s trade with other nations.”

Compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) where applicable helps ensure agricultural and veterinary chemical products (veterinary medicines including ectoparasiticides) meet minimum quality, safety and efficacy standards.

GMP Training Course Benefits

This course will familiarise you with these GMP requirements to enhance your knowledge of regulatory compliance responsibilities in Australia.

This online Certificate GMP training course will help you learn the APVMA Code of GMP for these products in an interactive, multi-media self-paced format. This allows you to learn on your own schedule, conveniently learning GMP rules from the comfort of your home or office.

Who should complete this course?

This course is suitable for life science professionals, production personnel, scientists/non-clinical laboratory personnel, contractors, maintenance workers, service providers, and Quality management personnel who work to manufacture, package, store, and/or distribute:

 

📌Veterinary medicines (veterinary chemical products), and/or
📌Pesticides (pesticide chemicals products including ectoparasiticides).

Examples of personnel who will benefit from this online course covering APVMA Code of GMP requirements:

✅ Operations personnel
✅ Production line personnel
✅ Owners/Managers including Quality Team personnel (Quality Managers)
✅ Operations Managers
✅ Production Managers and Manufacturing Engineers
✅ Laboratory Scientists/Product Engineers
✅ Authorised Persons responsible for batch release
✅ Internal Auditors/Inspectors and Authority personnel
✅ Personnel who receive incoming materials or manage inventory records
✅ Warehouse and Distribution personnel
✅ Logistics service providers working in the pharmaceutical and medical device manufacturing industry
✅ Transportation personnel, Wholesalers
✅ Veterinary Hospitals/Veterinary Medicine Schools who produce or distribute animal medicines
✅ People working in the Pesticide chemicals industry
✅ Other stakeholders

Flexible Online Learning Format

This self-paced GMP eLearning course allows participants to:
✔️ Access course materials anytime, anywhere (valid for 12 months from the date of purchase)
✔️ Learn at their own pace with real-world Case Studies
✔️ Combine online learning with instructor-led training options (virtual or onsite, where available)

It is recommended to review relevant GMP regulations and standards both before and after completing the course for best-practice compliance training (knowledge retention). Combining this course with onsite training, adequate Supervision, and public training courses also helps achieve a blended-learning experience and enhanced retention.

GMP Course Certificate

Completing this GMP eLearning ‘APVMA GMP Code’ course provides learners with a downloadable/printable GMP Certificate of Completion.

Important:

📌This certificate should be added to your company’s GMP Training Program records and personnel files.
📌It can also be attached to your Resume (CV) and listed as an accomplishment on professional profiles like LinkedIn.

How to complete this course:

• Add the course to your basket and complete your purchase.
• You can combine this course in a training bundle (search for the bundle tabs) if ordering multiple GMP courses
• Course fees are listed in US Dollars
• One user/per licence purchase (12 months’ access)
• Check your emails (all folders) for log-in instructions approximately 5 to 10 minutes after your order is finalised
• Be sure to search for/add the following domains to your safe sender’s list: “@onlinegmptraining.com” and “@pharmout.net”
• Review the content, answer the quizzes and final assessment, and click ‘back to course’ to download your Certificate once completed.
• You don’t have to complete this course in one session (you can stop learning and resume your place as often as you need to, or review the entire course as many times as you need to during the 12 month licence period).

Resources

Once you purchase this course, you’ll have access to the content for 12 months.

Other relevant GMP Education topics include:

• 10 Golden Rules of GMP
• Good Recordkeeping Practice (GRK)
• Good Laboratory Practice (non-clinical)
• Management of Deviations and Non-Conformances
• CAPA – Corrective and Preventive Actions
• Complaints Management
• Recall procedures for therapeutic goods/veterinary products
• GxP Computerised Systems & Validation in GMP Environments

Veterinary Medicines Regulations (Australia)

The APVMA Code of GMP is based on the following Australian legislation:

• The Agricultural and Veterinary Chemicals (Administration) Act 1992
• The Agricultural and Veterinary Chemicals Code Act 1994

What does the APVMA stand for and what does the APVMA in Australia do?

• APVMA = The Australian Pesticides and Veterinary Medicines Authority (APVMA).
• The APVMA is the Government entity that oversees product registration and the import, manufacture and export of veterinary chemical products and pesticides (up to the point of retail sale).
• You can download the GMP Code (PDF) from the APVMA for reference, which is recommended reading after completing this course to aid your retention.