Glossary

Program code statements which can never execute during program operation. Such code can result from poor coding style, or can be an artifact of previous versions or debugging efforts. Dead code can be confusing, and is a potential source of erroneous software changes.

A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Dead legs will be measured by the term L/D, where L is the leg extension from the I.D. wall normal to the flow pattern or direction, and D is the I.D. of the extension or leg of a tubing fitting or the nominal dimension of a valve or instrument. For valves, L shall be measured to the seal point of the valve. If a branch from a primary pipeline has demonstrated flow during cleaning and SIP, it does not constitute a dead leg.For high purity water systems, an L/D of 2 or less is attainable with today’s manufacturing and design technology. For other bioprocessing systems, such as purification, filtration, and fermentation having cluster, block, and multi-port valves, an L/D of 2 or less is achievable. However, it may not be achievable with certain equipment and process configurations as they are currently manufactured. For this part, an L/D of 2 or less shall be considered a target ratio, and shall not be construed to be an absolute requirement.

An area of entrapment in a vessel or piping run that could lead to contamination of the product.

An area of entrapment in a vessel or piping run that could lead to contamination of the product.

Dairy and Egg Branch (CFSAN)

Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.)

Determining the exact nature and location of a program error, and fixing the error.

Division of Education and Communication (CFSAN)

Deceased individuals. Afforded privacy rights under the HIPAA Privacy Rule, even though not considered "human subjects" protected under the Common Rule. As is the current practice, all research protocols involving the review of medical records of deceased subjects or of living and deceased subjects require review and approval by the HRC/IRB and can be conducted without informed consent and authorization only if the protocol satisfies the criteria for a waiver. If the research includes access to the records of decedents, the investigator will be asked to document that the decedents PHI will only be used for research and that the information is necessary for the research. The covered entity may require the investigator to provide proof of death.

Intentionally misleading or withholding information about nature of experiment.

A test coverage criteria requiring enough test cases such that each decision has a true and false result at least once, and that each statement is executed at least once. Synonym: Branch Coverage.

(ICH Q9) Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.

(IEEE) A table used to show sets of conditions and the actions resulting from them.

A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.

Breakdown of chemical into simpler parts, compounds, or elements.

Reduce microbial Bioburden, including spores, to a defined degree by means of a validated process.

A process that reduces contaminating substances to a defined acceptance level.

(USP <1072>) The removal of microorganisms by disinfection or sterilization.

A process that reduces contaminating substances to a defined acceptance level.

(FDA 2004 Aseptic Pocessing Guidance) A process that eliminates viable bioburden via use of Sporicidal chemical agents.

Process that reduces, detoxifies and/or eliminates contaminated substances to a predetermined acceptance level.

Reduction of unwanted matter to a defined degree.

Separate area, which may comprise one or more rooms within a multi-purpose facility with its own air-locked personnel/material accesses and HVAC systems, dedicated to a specific product or product range.

Physically separate or segregated building wit its own personnel/material accesses and heating, Ventilating and Air Condition (HVAC) systems, dedicated to process steps associated with a specific product or product range.