Glossary

Natural Organic Matter

A numerical identification of dimension, capacity, rating, or other characteristics used as a designation, not as an exact measurement.

An arbitrary micrometer value indicated by filter manufacturers. Based upon removal of some percentage of particles of a given size or larger, but rarely well defined and consequently not reproducible.

A numerical identification of outside diameter to which tolerances apply.

Based on retention efficiency, a filter should retain 99.9% of particles larger than its nominal rated pore size.

A numerical identification of wall thickness to which tolerances apply.

The strand of DNA that does not carry the information necessary to make a protein. The non-coding strand is the mirror image of the coding strand and is known as the antisense strand.

(EN 285) Air and other gas which will not condense under the conditions of steam sterilization.

A deviation from defined procedures. Failure to meet defined criteria may also be referred to as exception or deviation report.

An instrument whose failure is deemed to have no effect on product quality, process/system performance, safety, or the environment.

(IEEE) Examines software elements that are not designated safety-critical and ensures that these elements do not cause a hazard.

Examines portions of the code that are not considered safety-critical code to ensure they do not cause hazards. Generally, safety-critical code should be isolated from non-safety-critical code. This analysis is to show this isolation is complete and that interfaces between safety-critical code and non-safety-critical code do not create hazards.

A component within a system where the operation, contact, data control, alarm, or failure will have an indirect impact or no impact on the quality of the product.

A component within a system where the operation, contact, data control, alarm, or failure will have an indirect impact or no impact on drug quality

An instrument whose accuracy/failure is deemed to have no effect on product quality, process/system performance, safety, or the environment.

The process by which genetic counselors advise clients toward a certain test or outcome, particularly related to childbearing issues, without pressure or coercion.

A legal contract that describes confidential information such as specifications, data, documentation, or other technical or business information disclosed between two or more parties.

(ICH Q5A (R1)) Viruses from external sources present in the Master Cell Bank.

Facility design requirement resulting from decisions to address non-GMP issues, or manufacturer preferences. Often these do affect GMP related design features.

Malignant tumors that arise in the lymphatic system. There are several subtypes of cancer classified as non-Hodgkin lymphoma. All originate in and spread via the lymphatic system. Symptoms depend on the location of the tumor, but can include swollen, but not painful, lymph nodes; gastric distress; skin problems; night sweats; unexplained weight loss; itching; and fever. Diagnosis is by biopsy. Treatment may be chemotherapy, radiation, stem cell rescue, or medication, depending on the age of the patient and type of tumor.

Systems that may or may not require similar handling and erection procedures that those utilized by hygienic tubing systems but products transferred and/or conveyed through them will not have their identity, strength, quality, purity, or potency compromised.

A reformation of a program by immediately relinking the entire program following the testing of each independent module. Integration testing is then conducted on the program as a whole. Synonymous: "Big Bang" Integration.

A medicinal product not defined within the description of an IMP and may be considered a background, challenge, concomitant, endpoint, escape, or rescue medication dosed for preventive, diagnosis, or therapeutic reasons. The medicinal product can be provided by the study sponsor or the clinical site.