Glossary

Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges.

Documented verification that all aspects of a facility system which can affect product quality, performs as intended throughout all anticipated operating ranges.

(IEEE) Testing conducted to evaluate a system or component in its operational environment.

Provides sequencing based on priorities, attributes, characteristics, add/or recipes associated with specific production units at an operation such as shape, color sequencing, or other characteristics that, when scheduled in sequence properly, minimize set-up. It is finite and it recognizes alternative and overlapping/parallel operations in order to calculate, in detail, exact time of equipment loading adjusted to shift patterns.

The region of DNA that is upstream from a gene or genes and to which one or more regulatory proteins (repressor or activator) binds to control the expression of the gene(s).

Person working in the cleanroom performing production work or carrying out process procedures. ISO 14644-5.

A region of the chromosome, adjacent to the operon, where a repressor protein binds to prevent transcription of the operon.

The Operator’s Breathing Zone is defined as a 300mm (~12”) hemisphere extending in front of a person’s face measured from the mid-point of an imaginary straight line joining the ears.

A functionally integrated genetic unit for the control of gene expression in bacteria. It consists of one or more genes that encode one or more polypeptide(s) and the adjacent site (promoter and operator) that controls their expression by regulating the transcription of the structural genes.

Osteoprotegerin

Of, or relating to the eye; ocular.

Pertaining to products for the eyes. GMP requirements for the preparation of ophthalmics are essentially identical to those for parenterals.

Oriented Polypropylene

Office of Pesticides Programs

Organization of Pharmaceutical Producers of India

Owner’s Project Requirements

Office for Protection from Research Risks (NIH)

Office of Pharmaceutical Science (CDER)

Operations Committee (ISPE term)

Office of Pharmacoepidemiology and Statistical Science (CDER)

An information processing technology that converts human readable data into another medium for computer input. An OCR peripheral device accepts a printed document as input, to identify the characters by their shape from the light that is reflected and creates an output disk file. For best results, the printed page must contain only characters of a type that are easily read by the OCR device and located on the page within certain margins. When choosing an OCR product, the prime consideration should be the program's level of accuracy as it applies to the type of document to be scanned. Accuracy levels less than 97% are generally considered to be poor.

Thin glass wire designed for light transmission, capable of transmitting billions of bits per second. Unlike electrical pulses, light pulses are not affected by random radiation in the environment.

Instrument for measuring particle size and number by detecting the intensity and number of scattered light pulses.

(NIST) Modifying a program to improve performance; e.g., to make it run faster or to make it use fewer resources.