Glossary

(ICH Q6A) A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. "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. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.

(ICH Q6B) A 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. It establishes the set of criteria to which a drug substance, drug product or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

(EMEA – CHMP) A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria as appropriate for the tests described.

(USP) A list of tests, references to analytical procedures, and appropriate acceptance criteria. It establishes the set of criteria to which an excipient, drug substance, or drug product should conform to be considered acceptable for its intended use. “Conformance to Specification” means that the excipient, drug substance, and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria.

(IEEE) A document that specifies, in a complete, precise, verifiable manner, the requirements, design, behavior, or other characteristics of a system or component, and often, the procedures for determining whether these provisions have been satisfied.

(ICH Q7) A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. “Conformance to specification” means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

(ICH Q1A (R2)) The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug product at the time of its release.

(ICH Q1A (R2)) The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug substance throughout its re-test period, or that a drug product should meet throughout its shelf life.

(IEEE) Evaluation of each safety-critical software requirement with respect to a list of qualities such as completeness, correctness, consistency, testability, robustness, integrity, reliability, usability, flexibility, maintainability, portability, interoperability, accuracy, auditability, performance, internal instrumentation, security and training.

(IEEE) A diagram that depicts all of the specifications for a given system and shows their relationship to one

Documentation which clearly and explicitly defines the system requirements, codes and standards to be followed during fabrication and construction, test requirements, acceptance criteria and the associated deliverables.

Exerting a definitive and distinctive influence on a particular part of the body and on the course of a particular disease.

A measure of prediction that is equivalent to one minus the false-positive rate.

(ICH Q2 (R1)) The ability to assess unequivocally the analyte in the presence of components which may be expected to be present. Typically these might include impurities, degradants, matrix, etc.Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedure(s).This definition has the following implications:Identification:to ensure the identity of an analyte.Purity Tests: to ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e. related substances test, heavy metals, residual solvents content, etc.Assay (content or potency): to provide an exact result which allows an accurate statement on the content or potency of the analyte in a sample.

(ICH Q3B (R2)) A degradation product that is individually listed and limited with a specific acceptance criterion in the new drug product specification. A specified degradation product can be either identified or unidentified.

(ICH Q3A (R2)) An impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance specification. A specified impurity can be either identified or unidentified.

(ICH Q6A) An identified or unidentified impurity that is selected for inclusion in the new drug substance or new drug product specification and is individually listed and limited in order to assure the quality of the new drug substance or new drug product.

A visualization of all of an organism's chromosomes together, each labeled with a different color. This technique is useful for identifying chromosome abnormalities.

Abbreviation of spermatozoon.

The separation of sperm into those bearing an X chromosome and those bearing a Y chromosome, in order to be able to produce, via artificial insemination or in vitro fertilization, animals of a specified sex. Achieved by means of inactivation of X-bearing or Y-bearing sperm via antibodies directed against sex-specific peptides on the surface of sperm cells, or fluorescence-activated cell sorting (FACS), in which sperm that have been pre-treated with a fluorescent dye that binds to DNA are separated according to the quantity of fluorescence detected by a laser beam, based on the principle that X-bearing sperm contain more DNA than Y-bearing sperm.

One of the four cells formed by the meiotic divisions in spermatogenesis. Spermatids become mature spermatozoa (sperm).

The cell that undergoes two meiotic divisions (spermatogenesis) to form four spermatids; the primary spermatocyte before completion of the first meiotic division; the secondary spermatocyte after completion of the first meiotic division.