Glossary

The process of creating and managing duplicate versions of a database, but also synchronizes a set of replicas so that changes made tone replica are reflected in all the others. For database applications where users are geographically widely distributed, replication is often the most efficient method of database access.

The portion of a DNA molecule which is replicable from a single origin. Plasmids and the chromosomes of bacteria, phages and other viruses usually have a single origin of replication and, in these cases, the entire DNA molecule constitutes a single replicon. Eukaryotic chromosomes have multiple internal origins and thus contain several replicons. The word is often used in the sense of a DNA molecule capable of independent replication, e.g., “The shuttle vector pJDB219 is a replicon in both yeast and E. coli.”

The minimum level of an Impurity that must be reported, as defined in ICH Q3B.

(ICH Q3B (R2)) A limit above (>) which a degradation product should be reported.

(ICH Q3A (R2)) A limit above (>) which an impurity should be reported. Reporting threshold is the same as reporting level in Q2B.

A sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portraits the material being sampled.

A protein which binds to a specific DNA sequence (the operator) upstream from the transcription initiation site of a gene or operon and prevents RNA polymerase from commencing mRNA synthesis. Examples of repressors are the C1 protein of bacteriophage and the lac1 protein of the lac operon.

A system of reworking batches that do not conform to standards or specifications, including the steps taken to ensure that the reprocessed batches will conform to all established standards, specifications, and characteristics.

(ICH Q7) Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Continuation of a process step after an in process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing.

(ICH Q2 (R1)) Reproducibility expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology).

The production of an organism, cell or organelle like itself (self propagation).1. Sexual reproduction: the regular alternation (in the life-cycle of haplontic, diplontic and diplohaplontic organisms) of meiosis and fertilization (karyogamy) which provides for the production of offspring. The main biological significance of sexual reproduction lies in the fact that it achieves genetic recombination.2. Asexual or agamic reproduction: the development of a new individual from either a single cell (agamospermy) or from a group of cells (vegetative reproduction) in the absence of any sexual process.

Studies of whether exposure affects male or female fertility.

Execution of the test sequence specified for the installation to demonstrate compliance with ISO 14644-1 according to the classification of the installation, including the verification of the selected pre-test conditions. ISO 1464-2.

A question generated by a party in relation to an issued document – examples question concerning design drawing intent or clarification of a proposed parameter.

A question or series of questions posed to a supplier or other organization with the purpose of making an assessment. For example, questions relating to sourcingcapabilities and resources may be sent to a supplier in order to have data provided to assess

A documented representation of a condition or capability.

(IEEE) A condition or capability needed by a user to solve or achieve an objective. Also, a condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed documents.

(ISO) Need or expectation that is stated, generally implied or obligatory.

A detailed document used to specify the requirements of the client for individual aspects of the facility, item of equipment, utility and systems in terms of function, throughput, operability and applicable local standards.

(ICH Q9) The explicit or implicit needs or expectations of the patients or their surrogates (e.g., health care professionals, regulators and legislators). In this document, “requirements” refers not only to statutory, legislative, or regulatory requirements, but also to such needs and expectations.

(IEEE) The process of studying user needs to arrive at a definition of a system, hardware, or software requirements.

The process of studying and refining system, hardware, or software requirements. See: prototyping, software engineering.

(IEEE) The period of time in the software lifecycle during which the requirements, such as functional and performance capabilities for a software product, are defined and documented.

(IEEE) A process or meeting during which the requirements for a system, hardware item, or software item are presented to project personnel, managers, users, customers, or other interested parties for comment or approval. Types include system requirements review, software requirements review.

(NIST) A specification that documents the requirements of a system or system component. It typically includes functional requirements, performance requirements, interface requirements, design requirements (attributes and constraints), development (coding) standards, etc.