Veterinary drugs: Annex 4 to the good manufacturing practices guide for veterinary drugs

The interpretations in this section apply to all veterinary drugs except for:

• non-sterile non-prescription drugs with no withdrawal period for all approved species
• veterinary drugs that are subject to a published veterinary monograph and
• veterinary drug premixes

You can find guidance on these types of veterinary drugs in the tabbed pages for this document.

For non-segregated facilities that manufacture more than 1 class of drugs covered by this document, the most stringent interpretation applies.

On this page

• Sanitation
• Raw material testing
• Stability

Sanitation

C.02.007

Interpretation 3.f in GUI-0001 associated with campaign production is replaced with the following:

3.f In certain cases, campaign production can be accepted on a product-by-product basis. This is allowed if you can provide proper justification, conduct validation and ensure validated controls and monitoring are in place to minimize the risk of cross-contamination.

In facilities where other veterinary drugs are produced, campaign production of drug premixes containing penicillin is considered acceptable if:

• non-penicillin drug products for human use are not fabricated, packaged/labelled or stored in the same facility and
• the risk of cross-contamination is minimized with validated decontamination and cleaning procedures

Raw material testing

C.02.009

Interpretation 3 in GUI-0001 associated with specifications is replaced with new wording. The following wording makes it clear when house standards are acceptable for non-medicinal ingredients:

Make sure your specifications of APIs comply with current versions of all of the following:

1. the marketing authorization
2. a recognized pharmacopoeia
   1. where appropriate, include other properties or qualities not addressed by the pharmacopoeia (for example, particle size, polymorphs, density) in the specifications
   2. where a recognized pharmacopoeia (Schedule B of the Food and Drugs Act) contains a specification for microbial content, include that requirement

Specifications for other raw materials can be based on a house standard if those standards comply with the drug's current marketing authorization.

Stability

C.02.028

Interpretation 5 in GUI-0001 associated with 5 time points in continuing stability programs is supplemented with the following information to provide further clarity.

For drugs with an established shelf life and consistent historical stability profile, conduct testing at least every year, with a minimum of 5 time points (including the initial and final time points) unless otherwise approved in the marketing authorization.

Note: You should conduct your continuing stability program in a way that helps you detect changes and gives you sufficient data to support statistical analysis. A minimum of 5 time points will help you fulfill the requirements.

You may also reduce the number of time points in line with provisions of VICH GL3 Stability testing of new veterinary drug substances and medicinal products (for example, bracketing and matrixing).