APVMA Code of GMP (Veterinary Medicines)

Description

APVMA Code of GMP for Veterinary Medicines and Pesticides

Australian veterinary chemical products (and pesticides) must meet the GMP requirements detailed in the Australian Pesticides and Veterinary Medicines Authority (APVMA) Code of GMP.

Need to train your personnel to meet the Good Manufacturing Practice (GMP) requirements of this important Australian GMP code for veterinary medicines/chemical products and pesticides? This certificate GMP eLearning course will provide learners with an understanding of essential GMP principles for compliance with veterinary medicines regulations/AgVet manufacturing guidelines in Australia.

This GMP eLearning course covers compliance expectations per the APVMA’s Code of GMP for Veterinary Chemicals and Pesticides (AgVet products). This course agenda excludes the product-specific Annexes but includes interactive GMP content relevant to the 11 core GMP chapters of the APVMA Code of GMP. E.g., buildings and facilities, production, personnel requirements, health and hygiene, quality control and batch release expectations and documentation. 

It is recommended that this course be completed along with the Good Laboratory Practice (GLP) course, and other product-relevant GMP education where relevant.

This is one of our Certificate GMP Training Courses available in an eLearning format.

• Completing this GMP eLearning ‘APVMA GMP Code’ course will provide you (or your team of learners) with a downloadable/printable GMP Certificate of Completion.
• This Certificate should be added to your company’s GMP Training Program records and personnel files.
• The GMP Training Certificate can also be attached to your Resume (CV) and listed as an accomplishment on your professional LinkedIn profile or other industry-specific profile.

APVMA Code of GMP: Overview

About the APVMA and GMP rules for Veterinary Medicines & Pesticide Products

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.

Note: Products must be registered with the APVMA before they can be manufactured, imported, exported or distributed in Australia. For APVMA product registration information, click here.

Note: You can purchase multiple GMP eLearning courses in our discounted bundles. Click the bundles tab beneath the course image. However, the GLP course mentioned previously is a premium listing and is not available in the standard bundles, but you can add it to your course order.

GMP Guidance: Australian Veterinary Medicines

The APVMA expects companies involved in the agvet product industry in Australia to comply with the APVMA Code of GMP and related legislation.

Importance of Compliance and the APVMA Code of GMP

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

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.”

GMP & Quality Assurance

Veterinary medicinal products (veterinary chemical products), including ectoparasiticides, require compliance with GMP manufacturing principles and GxP/GLP rules covering:

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

 

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.

Australian Regulations for Veterinary Medicines

While 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.

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

• The GMP code for veterinary medicines — and other AgVet chemical products manufactured, used in or exported from Australia — are published by the APVMA.
• GMP compliance requirements listed in the APVMA Code of GMP are covered in this convenient online GMP compliance training course.
• In addition to completing training, you can download the GMP Code from the APVMA.

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

GMP Compliance: Course Participants

Who will benefit from this eLearning course covering compliance expectations linked to the APVMA Code of GMP?

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

• Veterinary medicines (veterinary chemical products), and/or
• Pesticides (pesticide chemicals products).

Topics covered in this course are relevant to GMP compliance expectations for Quality Management System (QMS) components, raw materials receipt/handling, processing, sampling, testing, packaging and labelling, batch release, and recordkeeping for raw materials/starting materials, intermediates, bulk products, and finished products.

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

• 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, and Veterinary Hospitals/Veterinary Medicine Schools working to produce or distribute veterinary medicines
• People working in the Pesticide chemicals industry
• Other stakeholders

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

Course Agenda: GMP eLearning course

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.

This course includes discussions and examples relevant to:

• The global regulatory landscape for Veterinary Medicines & Veterinary Product GMP Regulations
• Australian Legislation and GMP Guidance for Veterinary Chemical Products & Pesticides
• Personnel qualifications and training requirements including competency assessment requirements
• Quality Management System (QMS) expectations
• GMP Manufacturing Principles and Quality Controls
• Materials Management
• Essential requirements for procedures and processes, e.g. Deviations Management and Cleaning Procedures, Recordkeeping/Electronic Records, Batch Recordkeeping, Batch Release Procedures, etc.
• Other GMP requirements to ensure product quality, safety, and efficacy

About this course

• One user per licence. Users will have 12 months’ access to the course upon purchase.
• You can combine this course in a training bundle (search for the bundle tabs) if you need to order multiple training courses.
• Once you complete your order, check your email folders for your login information.