A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a raw material, drug substance or drug product should conform to be considered acceptable for its intended use.  Specifications are chosen to confirm the quality of the raw materials, drug substance and drug product rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the materials and products.

Before finished pharmaceutical dosage forms are produced, the identity, purity, and quality of raw materials must be established with the use of suitable test methods. Pharmacopoeial and formulary monographs such as the US Pharmacopeia–National Formulary (USP–NF), the European Pharmacopeia, and the Japanese Pharmacopeia provide standardized test methods for the most common and widely used materials.

“Conformance to specifications” means that the raw material, drug substance and/or drug 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. If the supplier’s specifications are inadequate for a GMP manufacturing process the final product may fail lot clearance while the original material was accepted for use because it was within specifications. This approach of adopting the supplier’s specification often stems from a sense of inadequacy in defining the material specifications in the first place. By not confronting the problem of defining adequate GMP raw material specifications early in the process, a manufacturer is forced to confront this issue later in the development process when their time and effort are better used with other activities.

Often, skilled resources and Quality expertise are not available to understand the regulatory requirements for developing, implementing and managing a compliant and robust materials and products qualification process. Kymanox’s broad expertise in implementing effective policies, robust testing processes and procedures will ensure your facility’s material and product qualification processes include all of the necessary compliance elements to meet the satisfaction of the internal and external customers it supports and serves, along with meeting the requirements of today’s global regulatory environment.