![]() This justification may consider theoretical tolerances for a given procedure or acceptance criterion, but the actual results obtained should form the primary basis for whatever approach is taken. Such justification should be based on data derived from the new drug substance synthesis and/or the new drug product manufacturing process. The applicant should justify alternative approaches. Approaches other than those set forth in this guideline may be applicable and acceptable. ![]() It is important to consider all of this information. Additionally, a reasonable range of expected analytical and manufacturing variability should be considered. The justification should refer to relevant development data, Pharmacopoeial standards, test data for drug substances and drug products used in toxicology and clinical studies, and results from accelerated and long term stability studies, as appropriate. When a specification is first proposed, justification should be presented for each procedure and each acceptance criterion included. It should be noted that changes in the specification after approval of the application may need prior approval by the regulatory authority. In this situation, the drug substance and / or drug product should meet the acceptance criteria if tested. In such cases the applicant should specify which tests are routinely conducted batch-by-batch, and which tests are not, with an indication and justification of the actual testing frequency. It is possible that, in addition to release tests, a specification may list in-process tests, periodic (skip) tests, and other tests which are not always conducted on a batch-by-batch basis. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. ![]() “Conformance to specifications” means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. It establishes the set of criteria to which a new drug substance or new drug product should conform to be considered acceptable for its intended use. Specifications: Definition and Justification Definition of Specifications:-Ī specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. SPECIFICATIONS: Test Procedures And Acceptance Criteria For New Drug Substances And New Drug Products: Chemical Substance. SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES(Q6A). ![]()
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