Final Product Testing and the Development of Specifications for Veterinary Pharmaceuticals
This chapter reviews the main concepts related to analytical testing of veterinary drug products and the development of specifications for critical quality attributes. Pragmatic strategies for the development and use of analytical specifications throughou
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Final Product Testing and the Development of Specifications for Veterinary Pharmaceuticals Jay C. Brumfield
Abstract This chapter reviews the main concepts related to analytical testing of veterinary drug products and the development of specifications for critical quality attributes. Pragmatic strategies for the development and use of analytical specifications throughout the veterinary product development and commercialization life cycle are discussed. Also presented are typical analytical testing requirements for quality assessment and registration of selected types of products in major markets (USA, EU, and Japan), and unique challenges related to several veterinarycentric dosage forms including medicated articles for preparation of feeds and drinking waters, and topical parasiticide preparations.
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Introduction
This chapter reviews the main concepts related to analytical testing of veterinary drug products and the development of specifications for critical quality attributes (CQAs). Pragmatic strategies for the development and use of analytical specifications throughout the veterinary product development and commercialization lifecycle are discussed. Also presented are typical analytical testing requirements for quality assessment and registration of selected types of products in major markets (USA, EU, and Japan), and unique challenges related to several veterinary-centric dosage forms including medicated articles for preparation of feeds and drinking waters, and topical parasiticide preparations.
J.C. Brumfield (*) Merck Animal Health, Summit, NJ, USA e-mail: [email protected] M.J. Rathbone and A. McDowell (eds.), Long Acting Animal Health Drug Products: Fundamentals and Applications, Advances in Delivery Science and Technology, DOI 10.1007/978-1-4614-4439-8_8, © Controlled Release Society 2013
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J.C. Brumfield
In this chapter, analytical testing refers to the nonclinical testing of physical, chemical, or microbiological quality attributes as typically accomplished using wet chemical, instrumental, or microbiological methods. As per the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), “a specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or medicinal product should conform to be considered acceptable for its intended use. ‘Conformance to specifications’ means that the drug substance and/or medicinal product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval” [1, 2]. Several critical points are captured in this definition. First is the fact that a specification is the sum of a test (i.e., a tested
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