Glossary

(ICH Q8 (R2)) The ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls.

A technique producing serum from anticoagulated plasma. Citrate and oxalate act as anticoagulants because they are Ca++ (Calcium Ion) chelating agents; Ca++ as calcium chloride is added in excess (1/40 Molar). Ca++ is a coagulation co-factor (catalyst) and promotes clot formation.

Recall (Product)The act of locating all units of a given lot of product that have been placed in the distribution chain for human use and ‘recalling’ them, for cause. Recalls are classified based on a risk assessment. (also see: Withdrawal)

The involved disciplines at an organization where a designated product, process, or method is expected to be transferred.

A molecule that can accept the binding of a ligand.

A gene that is expressed only when its counterpart allele on the matching chromosome is also recessive (not dominant). Autosomal recessive disorders develop in persons who receive two copies of the mutant gene, one from each parent who is a carrier.

A gene which will be expressed only if there are 2 identical copies or, for a male, if one copy is present on the X chromosome.

Information set required to produce a given product, with a given batch size (different batch sizes generally require different recipes).IEC 61512 (S88): A recipe is an entity that contains the minimum set of information that uniquely defines the manufacturing requirements for a specific product. Recipes provide away to describe products and how those products are produced.

A control strategy wherein variables may be changed to allow control of different processes with minimal impact on the basic computer code.

A recipe encompasses one of several recipe steps, organized in series and/or in parallel, according to the expected logic sequence of the recipe. A recipe step should be understood as a subset of the recipe that can be executed independently form the other recipe steps. Generally, a recipe step results into a series of chemical and/or physical transformation regarding the product. Example for production of PVC (Polyvinyl Chloride):• polymerize -- polymerization of vinyl chloride resulting in PVC• recover -- recover residual vinyl chloride• dry -- dry PVC

When a pair of chromosomes exchange exactly the same length and area of DNA. Results in a shuffling of genes.

Continuous recirculation may be necessary to maintain uniformly high purity in larger water systems. Water is continuously recirculated and reprocessed to prevent stagnation and to rinse out residual impurities in the system. Bacteria flourish in stagnant water, especially if temperature is conducive to growth.

Response Evaluation Criteria in Solid Tumors

A nucleotide sequence – composed typically of 4, 6 or 8 nucleotides – that is recognized by and to which a restriction endonuclease (restriction enzyme) binds. For type II restriction enzymes (those used in gene-cloning experiments) it is also the sequence within which the enzyme specifically cuts (and their corresponding enzymes methylate) the DNA, i.e., for type II enzymes, the recognition site and the target site are the same sequence. Type I enzymes bind to their recognition site and then cleave the DNA at some more or less random position outside that recognition site.

Pertaining to the recombining of genetic material from one species into alternate sequences. Plasmids may then be used to incorporate the genetic material into other organisms such as E. coli bacteria. Genetically altered microorganisms are usually referred to as recombinant; plants and animals so modified are called transgenic.

Clone containing recombinant DNA molecules.

The hybrid DNA produced by joining pieces of DNA from different sources.

In the context of the NIH Guidelines, recombinant DNA molecules are those constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from the replication of those described above.

Procedures that transfer genetic material between organisms or species.

The ability to chop up DNA, the stuff of which genes are made, and move the pieces, (which) permits the direct examination of the human genome, and the identification of the genetic components of a wide variety of disorders. Recombinant DNA technology is also used to develop diagnostic screens and tests, as well as drugs and biologics for treating diseases with genetic components.

A set of techniques which enable one to manipulate DNA. One of the main techniques is DNA cloning (because it produces an unlimited number of copies of a particular DNA segment), and the result is sometimes called a DNA clone or gene clone (if the segment is a gene), or simply a clone. An organism manipulated using recombinant DNA techniques is called a genetically modified organism (GMO). Among other things, recombinant DNA technology involves:– identifying genes;– cloning genes;– studying the expression of cloned genes; and– producing large quantities of the gene product.

An organism into which a foreign gene has been introduced.

The process of crossing over, which occurs during meiosis I. It involves breakage in the same position of each of a pair of non-sister chromatids from homologous chromosomes, followed by joining of non-sister fragments, resulting in a reciprocal exchange of DNA between non-sister chromatids within an homologous pair of chromosomes.

The International Council on Archives defines a record as “recorded information produced or received in the initiation, conduct or completion of an institutional or individual activity and that comprises content, context and structure sufficient to provide evidence of the activity.”Increasingly, electronic records can be distributed, compound objects.

(IEEE) A set of related data items treated as a unit, e.g., in stock control, the data for each invoice could constitute one record.