APVMA - Australian Code of Good Manufacturing Practice
for Veterinary Chemical Products

The new Good Manufacturing Practice regulations released by the APVMA in May 2006 come into force on 1st May 2007. The new regulations are significantly different, with more stringent GMP requirements, akin to those required for the manufacture of human drugs. Fortunately, in Australia the regulatory compliance expectation is better defined within the GMP codes. 

In the US the GMP regulations for veterinary and human drugs are identical, but are enforced by separate regulatory bodies within the FDA, namely the CDER, CBER or CVM. Similarly, the regulations in Europe are the same for both human and veterinary drugs.  

Exporters of human and/or veterinary drugs - which code applies?

If you are an Australian-based manufacturer of human and/or veterinary drugs the compliance requirements for each country you export to can seem bewildering.

The table below gives an overview of the regulations for the major world markets.

	Veterinary drug market			Human drug market
Target market	Australia	Europe	USA	Australia	Europe	USA
Likely auditing body for Australian manufacturers	APVMA	TGA/ APVMA (via the MRA)	CVM	TGA	TGA (via the MRA)	CDER/CBER
Applicable code
Final dosage form	APVMA code	Vol 4 = PIC/S	CFR 210/211	PIC/S Aust Code of GMP	Vol 4 = PIC/S	CFR 210/211
Active Pharmaceutical Ingredient (API)	API Code is not applicable	ICH Q7A API	ICH Q7A API	ICH Q7A API	ICH Q7A API	ICH Q7A API
Chemical suppliers to API plant	ISO9001	ISO9001	ISO9001	ISO9001	ISO9001	ISO9001

APVMA = Australian Pesticides & Veterinary Medicines Authority - GMP Code

Vol 4 (PIC/S) = GMP for Volume 4 - Medicinal Products for Human and Veterinary Use : GMP

FDA's CFR 210 and CFR 211 = FDA GMP regulations CFR 210 / 211

API (TGA) = Active Pharmaceutical Ingredient TGA - GMP Code (ICH Q7A)

API (FDA)= Active Pharmaceutical Ingredient FDA - GMP Code (ICH Q7A)

API (EU) = Active Pharmaceutical Ingredient EU - GMP Code (ICH Q7A)

Risk-based Compliance

We recommend that Australian manufacturers of human and veterinary drugs take a risk-based approach to compliance with these guidelines.

What makes the manufacturer's job very difficult is that the GMP code is subject to interpretation. For example, it makes no sense to enforce sterile human drug standards onto say a topical cream for pet cockatiels. The only objective methodology is to follow a risk-based approach, which gives the manufacturer the responsibility to defend his GMP position with good science and written justifications.

Step 1: High level risk assessment

Our experience as consultants tells us that the first step is a GMP Audit and a high level risk-assessment. This should be conducted by a cross-functional team of departmental leaders within the manufacturing plant. It is recommended that this task be facilitated by an independent consultant with experience from a range of manufacturing facilities. They will bring the same level of objective observation as an auditor. As GMP compliance consultants, PharmOut can provide the experience, templates and framework for this task.

We can help you with:

• Determining which regulatory code is applicable for the countries you export to
• Achieving affordable and sensible compliance with those code(s)

Step 2: Detailed GMP audit against the new APVMA GMP code

Once the high level risk assessment has been performed, a detailed GMP compliance audit (by our consultants) against each line item of APVMA code can be conducted. By checking off each line item, you will be able to perform a detailed GAP analysis.

If you need help with:

• Determining if you comply with the applicable codes (an audit-readiness review)
• A detailed GMP audit of current practices
• A detailed GMP audit checklist (email PharmOut and we will provide a free checklist)