Glossary

Extent of validation necessary to assure that changes made to the equipment, utilities, systems and process do not adversely affect the finished product. Implemented changes should be tracked and evaluated through a thorough, dynamic, change control program.

Relative to software changes, revalidation means validating the change itself, assessing the nature of the change to determine potential ripple effects, and performing the necessary regression testing.

Method by which suppliers compete to name their best price in a bid environment to be awarded a contract.

A process that reverses (by the application of pressure) the flow of water in the natural process of osmosis so that it passes from the more concentrated to the more dilute solution. This is one of the processes used to reduce the ionic TDS, TOC, and suspended materials of feed water through a semipermeable membrane leaving dissolved and suspended materials behind. These are swept away in a waste stream to drain.

The reversal of osmosis to purify water. In osmosis, water diffuses through a semipermeable membrane from a region of higher concentration (such as pure fresh water) into one of lower concentration (such as a solution of water and salt). The flow of water can be reversed with an opposing pressure that exceeds osmotic pressure. With RO, water is forced out of the lower concentrated solution (such as the salt solution), leaving the solute (impurities) behind.

A process that reverses (by the application of pressure) the flow of water in the natural process of osmosis so that it passes from the more concentrated to the more dilute solution. This is one of the processes used to reduce the ionic TDS, TOC, and suspended materials of feed water through a semipermeable membrane leaving dissolved and suspended materials behind. These are swept away in a waste stream to drain.

RO is one of two acceptable techniques for producing Water For injection (WFI), USP Procedure involves passing purified water across a semipermeable membrane against an osmotic gradient. RO is an excellent pretreatment for deionized water that will be subsequently filtered, because silt and colloids are removed. Usual performance of RO is removal of organics, multi-valent ions, and 90% of mono-valent ions.

The synthesis of DNA on a template of RNA, accomplished by reverse transcriptase.

(ICH Q3C (R4)) The occurrence of harmful effects that are caused by a substance and which disappear after exposure to the substance ends.

(ISO) Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.

(IEEE) A process or meeting during which a work product or set of work products, is presented to project personnel, managers, users, customers, or other interested parties for comment or approval. Types include code review, design review, formal qualification review, requirements review, test readiness review.

The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis. 45CFR46.108 (e)

The approach whereby manufacturing and quality data generated in validated Manufacturing Operations is screened to present or report only critical process exceptions required by approvers for review and disposition of intermediates and products; requirement for human review/approval of completed Electronic Production records only when a production parameter is out of specifications or there is some other discrepancy or critical exception condition.

(ICH Q7) Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).

A nondimensional parameter defined by the ratio of dynamic pressure and shearing stress.

Radio Frequency

The ratio of the distance moved by a particular solute to that moved by the solvent front.

Rotary Fluidized-Bed

Reference Doses

Radio Frequency Interference

Request For Information

Radio Frequency Identification (tracking tags)