Chapter 26 – Specification Setting and Manufacturing Process Control.pdfVIP

C H A P T E R 26 26 Specification Setting and Manufacturing Process Control for Solid Oral Drug Products Wei Chen, Suchinda Stithit, Jack Y. Zheng and Richard Hwang 26.1 INTRODUCTION procedures, raw materials testing, in-process testing, and stability testing .1–3 Specifications for the drug substance, in-process tests, and final product release The quality of drug products is determined by their tests must be based on development information e.g., design, development, process controls, GMP controls, batch history, stability, efficacy, and toxicity , and cer- process validation, and by specifications applied to 1,2 tainly evolve with the cumulative knowledge gained them throughout development and manufacturing. during product research and development. In all As part of GMP controls the quality of any drug prod- cases, specifications either in the clinical trial stages or uct must be evaluated using methods and criteria in the commercialization stage are chosen to confirm listed in its specifications. According to ICH Q6A, a 1 the quality of the drug product, and thus must focus specification is defined as: on the product characteristics that ensure the identity, A list of tests, references to analytical procedures, and strength, and purity of the drug product at release, appropriate acceptance criteria that are numerical limits, as well as throughout the duration of clinical trial or ranges or other criteria for the tests described. It establishes the shelf life for commercial products. It is important the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended to have solid rationale and scientific justification for use. Conformance to specification means that the material, including and/or excluding testing for specific qual- wh