Glossary

A bacterial or plant cell for which the relatively rigid wall has been removed either chemically or enzymatically, leaving its cytoplasm enveloped by only a delicate peripheral membrane. Protoplasts are spherical and smaller than the elongate, angular shaped and often vacuolated cells from which they have been released.

An organism such as a bacterium that will grow on a minimal medium.

Using software tools to accelerate the software development process by facilitating the identification of required functionality during analysis and design phases. A limitation of this technique is the identification of system or software problems and hazards.

Nucleated microorganisms, some of which are large enough to be detected with the naked eye. They consist of a single cell and or an aggregation of nondifferentiated cells loosely held together and not forming tissues. The protozoa are divided into four classes: Sarcodina, Mastigophora, Sporozoa, and Infusoria (Ciliata).

(ICH Q8 (R2)) A characterised range of a process parameter for which operation within this range, while keeping other parameters constant, will result in producing a material meeting relevant quality criteria.

A range for a critical parameter that has been determined to be achievable and appropriate for the process or processes with which it is associated. It is established by knowledge gained through relevant documentation and actual testing. A process should perform consistently and as intended when all critical parameters are held within the established PARs.

A retrovirus in which the single RNA strand has been converted into a double-strand DNA, which has been integrated into a host genome.

Prion Protein, Scrapie variety

Pressure Reducing Valve

Pseudorabies Virus

Polystyrene

Pure Steam

Pressure Swing Asdsorption

Prostate-Specific Antigen

Prevention of Significant Deterioration of air quality permit (EPA Regulations)

Particle Size Distribution

Periodic System Evaluation