Glossary

In reverse osmosis or ultrafiltration, the ratio of pure water output to feedwater input.

In reverse osmosis or ultrafiltration, the ratio of impurities removed to total impurities in the incoming feedwater. For example, RO membranes typically remove (reject) 90% of the dissolved inorganic contaminants in water.

A perfect fluid is defined as a fluid with zero viscosity (i.e., inviscid)

Software maintenance performed to improve the performance, maintainability, or other attributes of a computer program.

Provides up-to-the-minute reporting effectual Manufacturing Opeations results along with the comparison to past history and expected business results. Preformance results include such measurements as resource utilization, resource availability, product unit cycle time, conformance to schedule, and performance to standards. It may include SPC/SQC. Performance Analysisi draws on information gathered from different functions that measure operating parameters. These results may be prepared as a periodic report or presented on-line as current evaluation of performance.

Mechanism whereby the owner is entitled to a specific sum of money for the failure of the supplier to properly perform the contract or becomes insolvent.

(ICH Q10) Measurable values used to quantify quality objectives to reflect the performance of an organization, process or system, also known as “performance metrics” in some regions.

Documented verification that the process and/or the total process related system performs as intended throughout all anticipated operating ranges.

For “Direct Impact” systems, the documented verification that all aspects of a facility, utility or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria.

The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification

Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.

For “Direct Impact” systems - The documented verification that all aspects of a facility, utility or equipment that can affect product quality, perform as intended meeting predetermined acceptance criteria.

(IEEE) A requirement that imposes conditions on a functional requirement; e.g., a requirement that specifies the speed, accuracy, or memory usage with which a given function must be performed.

(IEEE) A document that sets forth the performance characteristics that a system or component must possess. These characteristics typically include speed, accuracy, and memory usage. Often part of a requirements specification.

The process by which the performance of interdependent systems is demonstrated as within the required tolerances, the output of interdependent systems is demonstrated as delivering the required duty or capacity, the interdependent functions of systems are demonstrated to be as specified and appropriate.

(IEEE) Functional testing conducted to evaluate the compliance of a system or component with specified performance requirements.

A systematic method of assigning compounds to one of four categories based on potency, pharmacology, acute toxicology, therapeutic class, therapeutic dose, genotoxicity, and bench-marking. PB-OELs differ from OELs in that PB-OELs are established early in preclinical development before or at Investigational New Drug (IND) phase, they are order(s) of magnitude estimation of the OEL, provide guidance on engineering controls that will meet the OEL, protect the scientists and development engineers during product/process development, and enable companies to accelerate drug development. PB-OELs achieve containment primarily with engineering controls.Airborne concentrations vary predictably with the process equipment utilized, transfers in and out of equipment, degree of containment, how equipment is cleaned, and whether the facility design includes airlocks and general ventilation. Based in these considerations a containment technology hierarchy has been established:1.Category I > 100 µg/m³ - Low to moderate toxicity and pharmacological activity, no teratogens, mutagens, or carcinogens, low acute/chronic systemic effects, low potency, reversible effects, and first aid/simple medical treatment. - At this level, local exhaust and general ventilation are utilized, and adhering to normal cGMPs is usually enough protection for an operator, this should include hair and shoe covers and the requirement to change into a uniform that is laundered or replaced. For process areas, access to change/locker rooms and showers is required.2.Category II > 100 µg/m³ - <20 µg/m³ ? Irritant; good warning properties, no teratogens, mutagens, or carcinogens, onset of symptoms is immediate, low acute/chronic systemic effects, low potency, reversible effects, and requires first aid/simple medical treatment. - This is the first category that requires the use of special equipment such as unidirectional laminar flow booths to create an additional separation between the operator and the materials being handled. Process areas must have adjoining change/locker rooms available.3.Category III >20 µg/m³ - <5 µg/m³ - Moderate to high acute systemic toxicity, moderate chronic systemic toxicity, reversible effects, sensitizer, onset of symptoms immediate to delayed, weak mutagens, moderate degree of medical intervention may be required, compounds of unknown toxicity. - At this level the lower level of the capabilities of unidirectional laminar flow technology has been reached, and another level of control (barrier technology) such as Split Butterfly Valves (SBVs) must be used to separate the operator from the material being handled. Process areas must have adjoining change/locker rooms, and a decontamination area is strongly recommended.4.Category IV <5 µg/m³ - Highly potent, high acute and/or chronic systemic effects, irreversible effects, extreme sensitizer, mutagen, developmental toxicity, reproductive toxicity or carcinogen, none or poor warning properties, immediate and delayed onset of symptoms, high degree of medical intervention needed. - At this level, the guaranteed limits of SBVs have been reached and to meet the containment requirements, Isolation Technology such as robotics, or glove boxes with Rapid Transfer Ports (RTPs) need to be used. Process areas must have adjoining change/locker rooms for production, maintenance, service, and decontamination. Decontamination required prior to entry to change/degowning room.NOTE: Most manufacturers of potent compounds establish categories based upon the exposure limits of the products. The above-mentioned Categories (I through IV) and their limits in µg/m³ (micrograms per cubic meter) are an example of a standard based upon the equipment capabilities. It is a base to assist in the design of new solid dosage facilities, and to weigh the impact on existing facilities, and health and safety operational changes that may preclude capital investment.

A method of cell culture that differs from batch or fed-batch methods in that cells are maintained in a relative steady state of cell concentration and productivity. Perfusion involves physical retention of cells and includes a system in which waste (spent) medium is continually replaced with fresh medium. Perfusion cultures are characterized by relatively high cell densities.

A documented assessment pf the documentation, procedures, records, and performance of a computer system to determine whether it is still in a validated state and what actions, if any, are necessary to restore its validated state. The frequency of review is dependent upon the systems complexity, criticality, and rate of change.

A documented assessment of documentation, procedures, records, and performance to ensure tha facilities, equipment, and systems continue to be fit for purpose and safety regulatory compliance requirements. The frequency of periodic review is dependent upon the complexity, criticality, and rate of change.

Testing that is done on some frequency less than every lot but more than initial qualification.

Equipment that is directly connected a computer. A peripheral device can be used to input data; e.g., keypad, bar code reader, transducer, laboratory test equipment; or to output data; e.g., printer, disk drive, video system, tape drive, valve controller, motor controller. Synonymous: Peripheral Equipment.