ISPE Glossary of Pharmaceutical and Biotechnology Terminology
A noncellular organism and an intercellular parasite, consisting of nucleic acid (DNA or RNA) in an outer coat of protein. Viruses can live and reproduce only in susceptible host cells; host cells can be bacteria, plant, or animal. The host cell’s synthesis is often inhibited by the infecting virus, which may or may not result in disease (more than 200 viruses are known to produce human disease). An individual virus particle is called a virion, and virions vary in structure, complexity, and size (ranging from 20-25 nm or less to 2,000 nm or more). Six classes of virus are defined by whether they are single or double stranded, DNA or RNA, or positive or negative.
A “genetic parasite”, which attaches a host cell and alters its genetic program so that it produces viruses. Many viruses are completely harmless, while others are lethal. Viruses are so small that they can be seen only under an electron microscope with ten-thousandthfold magnification.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
A program which secretly alters other programs to include a copy of itself, and executes when the host program is executed. The execution of a virus program compromises a computer system by performing unwanted or unintended functions which may be destructive.
Publication Source: FDA Glossary of Computerized System and Software Development Technology
See also:
Bomb
Trojan Horse
Worm
Generic term for all the various types of malicious code that has been designed to breach a company’s security requirements/measures.
Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
Publication Date: 2005
(ICH Q5A (R1)) Intracellularly replicating infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA), are unable to grow and undergo binary fission, and multiply in the form of their genetic material.
Publication Source:
See also:
Endogenous Virus
Non-Endogenous Virus
Non-Specific Model Virus
Relevant Virus
Specific Model Virus
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