Glossary

A protein that recognizes specific, short nucleotide sequences and cuts DNA at those sites. Bacteria contain over 400 such enzymes that recognize and cut over 100 different DNA sequences.

A class of nucleases that degrades DNA or RNA, starting from an end either 5’ or 3’.

The occurrence of variation in the length of DNA fragments that are produced after cleavage with a type II restriction endonuclease. The differences in DNA lengths are due to the presence or absence of recognition site(s) for that particular restriction enzyme. RFLPs were initially detected using hybridization with DNA probes after separation of digested genomic DNA by gel electrophoresis (Southern analysis). Now they are typically detected by electrophoresis of digested PCR product.

Analysis of the data collected during a trial.

The part of the mixture that is held back by a filter.

Monies that are held by the Owner to assure all services and goods have been provided as per the contract.

Carryover of material on product contact surfaces from one product to another in the same equipment used in a sequential or campaign manner; the residue or accumulated product on product contact surfaces.

(ISO) The length of time specified for data on a data medium to be preserved.

The time period that a record is required to be kept available for ready inspection by a regulatory agency.

Set of instructions allocated to a class of records to determine the length of time for which they should be retained by the organization for business purpose, and the eventual fate of the records on completion of this period of time.

The period of time between initial application of an elution buffer and the exit from the column of a particular sample component.

The period of time between initial application of an elution buffer and the exit from the column of a particular sample component.

(ICH Q7) The date when a material should be re-examined to ensure that it is still suitable for use.

(ICH Q1A (R2)) The date after which samples of the drug substance should be examined to ensure that the material is still in compliance with the specification and thus suitable for use in the manufacture of a given drug product.

(ICH Q1A (R2)) The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions. After this period, a batch of drug substance destined for use in the manufacture of a drug product should be re-tested for compliance with the specification and then used immediately. A batch of drug substance can be re-tested multiple times and a different portion of the batch used after each re-test, as long as it continues to comply with the specification. For most biotechnological/biological substances known to be labile, it is more appropriate to establish a shelf life than a re-test period. The same may be true for certain antibiotics.

The system of macrophages, which serves as an important defense system against disease.

An eye cancer caused by the loss of a pair of tumor-suppressor genes; the inherited form typically appears in childhood, since one gene is missing from the time of birth.

Loading of archived data onto a computer system for business purposes requiring access to the old data.

Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.

(IEEE) A trace produced from historical data recorded during the execution of a computer program. Note: this differs from an ordinary trace, which is produced cumulatively during program execution.

Establishing documented evidence that a system does what it purports to do based on review and analysis of historic information.

The presence of retroviral vectors, such as some viruses, which use their recombinant DNA to insert their genetic material into the chromosomes of the host’s cells. The virus is the propagated by the host cell.

A class of eukaryotic RNA viruses that can form doublestranded DNA copies of their genomes by using reverse transcription; the double-stranded forms integrate into chromosomes of an infected cell. Many naturally occurring cancers of vertebrate animals are caused by retroviruses. Also, the AIDS virus is a retrovirus.

Air removed mechanically from the space and returned to the air handling system serving that space for recirculation.

Validation of a previously validated system that has been changed or modified. Revalidation can be performed as the result of a change to the system, or a time based assessment.