One of the important aspects of drug and drug product development is providing specifications that must be conformed to for the product to be considered acceptable for its intended use. According to the definition by the International Conference on Harmonization (ICH), specifications refer to “a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described.” This is a critical quality standard where the manufacturers propose and justify the conditions that form the basis for the approval by regulatory authorities.
The specifications are detailed during the product design stage, clearly defining the objectives the product is expected to achieve using specific components, containers, closures, in-process materials, and finished products.
To ensure that the product conforms to the specifications, laboratory testing is mandated by regulatory bodies such as CGMP (§§ 211.160 and 211.165). It ensures that not only does the product perform as required but all components and other aspects mentioned above meet the specifications criterion.
When the results of the laboratory test show the product values to be outside the specifications or acceptance criteria, it is said to be Out-of-Specification or OOS. Further action needs to be taken to prevent its rejection or receiving a warning letter from the FDA based on a root cause analysis.
Request an Online Demo