Design of Materials and Product Specifications

Abstract A pharmaceutical industry is governed by specific regulatory bodies where the quality of any pharmaceutical product is given prime importance. Drug development process requires thorough planning to avoid failure to meet quality allied goals. Improper process designing leads to the quality deficit product, resulting in massive loss of company’s share in the market. Therefore, various guidelines have been implemented relevant to the design and development of the high-quality pharmaceutical product. Designing of specification in various aspects of drug development is considered as one of the most crucial steps for maintaining quality standard. In the present chapter, the basic objectives of designing the specification of drug substance and drug product have been explained while highlighting its importance and scope. Detail account of the guidelines has also been mentioned for better understanding to contextualize the chapter.