GMP codes - which apply?

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
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

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 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