Product Specifications Setting and Review Process for New Drug Entities

Abstract

Marketed drug product specifications cannot be set unless a comprehensive and representative dataset is available. The stability dataset intended for use in setting marketed product specifications is frequently not comprehensive if the active compound has a large number of low level impurities. Recent global regulatory guidelines recommend specifications for all impurities which exceed 0.1% in new drug entities. On par with the requirement for comprehensive data is the requirement that the data be representative of the product proposed for marketing. In cases where the marketed product specifications are deemed to be nonrepresentative, frequently the problem originated with a lack of formal procedures for specification setting and review during the product development phase. Two guidelines were devised which define a specifications establishment and control process. One guideline specifies the data requirements for specification setting at each stage of product development. The second guideline establishes a structured forum for communication of specification-related information throughout the product life cycle. These guidelines, used in concert, define a mechanism for establishment of marketed product specifications which are “right the first time.”