MLS Glossary

Category of manufacture / product

Type of manufacture for example, sterile products, immunobiologicals, non-sterile products, ectoparasiticides, premixes and supplements.

Category 1 - Immunobiologicals and sterile veterinary preparations
Category 2 - Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements
Category 3 - Ectoparasiticides
Category 4 - Premixes and supplements
Category 6 - Single step manufacture

(Note: Category 5 not used)

Finished product/end-use-product

A completed product which has undergone all stages of production, and which is 'bottled' or packaged, sealed and labelled as required for registration purposes.

GMP Codes

Australian Code of Good Manufacturing Practice for Veterinary Chemical Products

Manufacture

All operations (steps) involved in the manufacture of veterinary chemical products, including purchase and quality assurance of raw materials, processing and blending or assembly, quality control, packaging, labelling, sterilising and microbiological reduction, analysis and testing, in-process storage, and releasing from manufacture for supply.

Manufacturer

Any person (individual or legal entity) involved in any step of manufacture of veterinary chemical product(s).

Step of manufacture

A single, discrete manufacturing activity, e.g. sterilisation, testing, packaging, labelling, etc.

Sterile or Sterility

Freedom from viable contaminating micro-organisms as described in European Pharmacopoeia or other contemporary standards. The level of assurance provided by the absence of contamination in the sample as applied to the quality of the batch is a function of both the efficiency of the sampling plan adopted as well as the rigour of the methods employed.