- Docket Number:
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Guidance Issuing OfficeOffice of Foods and Veterinary Medicine, Center for Veterinary Medicine
The quality of drug substances and medicinal products is determined by their design, development, in-process controls, GMP controls, and process validation, and by specifications applied to them throughout development and manufacture. This guidance addresses specifications, i.e., those tests, procedures, and acceptance criteria which play a major role in assuring the quality of the new veterinary drug substance and medicinal product at release and during shelf life. Specifications are an important component of quality assurance, but are not its only component. All of the considerations listed above are important to ensure consistent production of drug substances and medicinal products of high quality.
This guidance addresses only the marketing approval of new medicinal products (including combination products) and, where applicable, new drug substances; it does not address drug substances or medicinal products during the clinical research stages of drug development. This guidance may be applicable to synthetic and semi-synthetic antibiotics and synthetic peptides of low molecular weight; however, it is not sufficient to adequately describe specifications of higher molecular weight peptides and polypeptides, and biotechnological/biological products. Radiopharmaceuticals, products of fermentation, oligonucleotides, herbal products and crude products of animal or plant origin are similarly not covered.
Guidance is provided with regard to acceptance criteria which should be established for all new drug substances and new medicinal products, i.e. universal acceptance criteria, and those that are considered specific to individual drug substances and/or dosage forms. This guidance should not be considered all encompassing. New analytical technologies, and modifications to existing technology, are continually being developed. Such technologies should be used when justified.
Dosage forms addressed in this guidance include solid oral dosage forms, powders, liquid oral dosage forms, and parenterals (small and large volume). This is not meant to be an all-inclusive list, or to limit the number of dosage forms to which this guidance applies. The dosage forms presented serve as models, which may be applicable to other dosage forms which have not been discussed. The extended application of the concepts in this guidance to other dosage forms, e.g., to topical formulations (pour-on, spot-on, creams, ointments, gels) is encouraged.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2005-D-0336.