Australian Code of Good Manufacturing Practice, APVMA code of GMP
Veterinary drugs in Australia are required to comply with the Good Manufacturing Practice regulations published by the APVMA in 2007.
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.
Often exporters of human and/or veterinary drugs need to determine 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|
|Likely auditing body for Australian manufacturers||APVMA||TGA/ APVMA (via the MRA)||CVM||TGA||TGA(via the MRA)||CDER/CBER|
|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 / CFR 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)
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 Code of GMP
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