Glossary

Room Criteria

Root Cause Analysis

Root Cause Failure Analysis

Reliability Centered Maintenance

Refrigeration Control Panel

Resource Conservation and Recovery Act (EPA Regulations)

Randomized Clinical Trials

Relational Database Management System

recombinant DNA

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

Radioactive Drug Research Committee (FDA)

The process of creation, approval, issuance, and applications of labels (IMP or auxiliary labels) to update, e.g., use-by dates.

Registration, Evaluation, Authorisation and Restriction of Chemical Substances (United Kingdom)

A chemical transformation or change.

Operating a piece of equipment until it fails and then making a repair or replacement. Failure does not necessarily imply a complete breakdown – it might just mean that the equipment is operating outside of specified parameters.

The ability of a substance to undergo a chemical reaction (such as combining with another substance). Substances with high reactivity are often quite hazardous.

A memory chip from which data can only be read by the CPU. The CPU may not store data to this memory. The advantage of ROM over RAM is that ROM does not require power to retain its program. This advantage applies to all types of ROM chips; ROM, PROM, EPROM, and EEPROM.

A substance used (as in detecting or measuring a component, in preparing a product, or in developing photographs) because of its chemical or biological activity.

(ICH Q6A) A substance, other than a starting material or solvent, which is used in the manufacture of a new drug substance.

(ICH Q3A (R2)) A substance other than a starting material, intermediate, or solvent that is used in the manufacture of a new drug substance.

Water suitable for use in making up reagents or for use in sensitive analytical procedures. There are several grades of reagent grade water as defined by various professional organizations such as ASTM, CAP, NCCLS, and ACS:1.Type I: Used for procedures requiring maximum accuracy and precision, such as atomic spectrometry, flame photometry, enzymology, blood gas, pH and specific ion determinations; reference buffer solutions; and reconstitution of lyophilized materials used as standards. ASTM to produce Type I water specifies distillation pretreatment of feedwater.2.Type II: Recommended for most analytical or general laboratory testing such as hematological, seralogical, and microbiological procedures as well as chemical methods not specifically stated or proven to require Type I quality. ASTM specifies preparation of Type II by distillation and recommends it whenever freedom from organic impurities is important.3.Type III: Satisfactory for some general laboratory tests; for most qualitative analyses such as urinalysis, parasitology, and histological procedures; for rinsing of analytical samples; preparation of stock solutions; and for washing or rinsing of glassware (final glassware rinsing should be performed with the water type specified for the procedure performed). Distillation, mixed-bed deionization, and reverse osmosis (with high quality feedwater) can be used to generate Type III.

(IEEE) Pertaining to a system or mode of operation in which computation is performed during the actual time that an external process occurs, in order that the computation results can be used to control, monitor, or respond in a timely manner to the external process.

A fast-response (immediate response) on-line system which obtains data from an activity or a physical process, performs computations, and returns a response rapidly enough to affect (control) the outcome of the activity or process; e.g., a process control application.