Glossary

Likelihood of causing an adverse and unintended effect.

Likelihood of affecting product quality.

Likelihood of affecting product quality.

Defined and delimited space where individuals, products or materials (or any combination of these) are particularly vulnerable to biocontamination.

Defines how the risks associated to the scope change will be managed, identifies the risk factors, creates a risk probability and impact rating details how change scope risk factors will be monitored and managed.

Risk-MaPP provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross-contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

Provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

Provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

Provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety.

Rapid Microbial Method

Risk Management Planning

Root Mean Square

Ribonucleic Acid

A natural process used by organisms to block protein production.

Reverse Osmosis

High quality water generated by Reverse Osmosis.

Reverse Osmosis/Electrodeionization

(ICH Q2 (R1)) The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

The degree to which a software system or component can function correctly in the presence of invalid inputs or stressful environmental conditions.

A standard method for measuring the hardness of metals. The hardness is expressed as a number related to the depth of residual penetration of a steel ball or diamond cone (brale) after a minor load of 10 kilograms has been applied to hold the penetrator in position. This residual penetration is automatically registered on a dial when the major load is removed from the penetrator. Various dial readings combined with different major loads, five scales designated by letters varying from A to H; the B and C scales are most commonly in use.

Return on Investment

Small cylindrical bottles often used as bioreactors in the production of products by cell culture. The bottles are kept on a device that rotates them slowly to help assure proper growth. Automated systems may also be used for large arrays of roller bottles introducing sterile media and harvesting finished product automatically. In large-scale vaccine production, roller bottles have been replaced by microcarrier culture systems that offer the advantage of scale-up.

Read Only Memory

Room temperature indicates the temperature prevailing in a working area.