The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted a number of VICH guidelines that outline the procedures recommended for generating relevant chemistry and manufacture data for your application.
Applicants should refer to these guidelines, in conjunction with the general guidelines for chemistry and manufacture of active constituents and products, when generating chemistry and manufacture data or preparing chemistry data dossiers for submission.
Chemistry and manufacture guidelines for veterinary chemical products
VICH guidelines
- GL1:Validation of analytical procedures: definition and terminology
- GL2: Validation of analytical procedures: methodology
- GL3(R): Stability: stability testing of new veterinary drug substances (revision)
- GL4: Stability testing for new dosage forms
- GL5 (Stability 3): Stability testing: photostability testing of new veterinary drug substances and medicinal products
- GL8: Stability testing for medicated premixes
- GL10(R): Impurities in new veterinary drug substances (revision)
- GL11(R): Impurities in new veterinary medicinal products (revision)
- GL17: Stability testing of new biotechnological/biological veterinary medicinal products
- GL18: Impurities: residual solvents in new veterinary medicinal products, active substances and excipients
- GL39: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances
- GL40: Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
- GL45: Quality: bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
- GL51: Statistical evaluation of stability data
Other guidelines
The FDA, EMA and Heath Canada websites also provide guidance which may be useful when generating chemistry and manufacture data.
- U.S Food and Drug Administration (FDA) guidelines
- European Medicines Agency (EMA) guidelines; eg the in-use stability guideline EMEA/CVMP/424/01
- Health Canada guidelines
Related guidelines
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