Glossary

A quality system defined by 21CFR Part 820.100; the policies, procedures, and support systems that enable a firm to assure that exceptions are followed up with appropriate actions to correct a defined situation, and with continuous improvement tasks to prevent recurrence and eliminate the cause of potential nonconforming product and other quality problems.

Maintenance performed to ensure equipment, systems, or facilities remain in their qualified state and fit for intended and continued use.

(IEEE) Maintenance performed to correct faults in hardware or software.

(IEEE) The degree to which software is free from faults in its specification, design and coding. The degree to which software, documentation and other items meet specified requirements. The degree to which software, documentation and other items meet user needs and expectations, whether specified or not.

A chemical reaction of metals with the environment to form an oxide, carbonate, sulfate, or other stable compound.

A chemical or electrochemical interaction between a metal and its environment, which results in changes in the properties of the metal. This may lead to impairment of the function of the metal, the environment, and/or the technical system involved.

Uniform dissolution of the metal surface exposed to a corrodent. Expressed as corrosion “rate”.

Substance that causes destructive chemical change of a surface.

A chemical that causes visible destruction or irreversible alterations in living tissue by chemical action at the site of contact. A chemical is considered corrosive if, when tested on the intact skin of albino rabbits by the method described in Appendix A of CFR 49 Part 173, it destroys or changes irreversibly the structure of the tissue at the site of contact following an exposure period of four hours. This term shall not refer to action on inanimate surfaces.

A liquid which when in contact with living tissue, will cause destruction or irreversible alteration of such tissue by chemical action. Examples include acidic, alkaline, or caustic materials.

Certificate of Suitability

Cosmetic Registration Number (AofC code)

Cosmetics Staff (CFSAN)

Control of Substances Hazardous to Health

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Also, articles intended for use as a component of any such articles; except that such term shall not include soap.

Artificially constructed cloning vector containing the cos gene of phage lambda. Cosmids can be packaged in lambda phage particles for infection into E. coli: this permits cloning of larger DNA fragments (up to 45kb) that can be introduced into bacterial hosts in plasmid vectors.

Monitoring the change risk factors, obtaining agreement from all parties involved in a cost change, and monitoringthe actual changes to assure they track according to projections.

Coding Symbols for Thesaurus of Adverse Reaction Terms

Career Opportunities Training Agreement (HHS)

Communication Technology Branch (CBER)

Commercial Off-the-Shelf Software

Committee of Ten Thousand

Median particle diameter based on the number of particles.NOTE: For the count median, one half of the particle number is contributed by particles with a size smaller than count median size, and one half by particles larger than the count median size.

A pharmaceutical product that is deliberately and fraudulently mislabeled with respect to identity, strength, purity, fnction and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients, with the wrong ingredients, without active ingredients, with an insufficient quantity of active ingredient or with fake packaging.

Ratio of the reported concentration of particles in a given size range to the actual concentration of such particles.