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QA (Quality Assurance)
The sum total of the organized arrangements made to ensure that all APIs
(Active Pharmaceutical Ingredients) are of the quality required for their
intended use and that quality systems are maintained.
QC (Quality Control)
Checking or testing, that specifications are met, or the regulatory process
through which the industry measures actual quality performance, compares it
with standards, and acts on the difference.
Qualification
Action of providing that equipment or ancillary systems are properly
installed, work correctly, and actually lead to the expected results.
Qualification is part of validation, but the individual qualification steps
alone do not constitute process validation.
Quality Assurance (QA) Group
The group who interprets the GMP regulations and guidelines.
Quality Control (QC) Group
The group who enforces the GMP regulations.
Quality Unit(s)
An organizational unit independent of production that fulfills both Quality
Assurance and Quality Control responsibilities. This may be in the form of
separate QA and QC units, a single individual (or group), depending upon the
size and structure of the organization.
Quality Function
The entire collection of activities from which the industry achieves
fitness for use, no matter where these activities are performed.
Quarantine
The status of materials isolated physically or by other effective means
pending a decision on their subsequent approval or rejection.
Quick Stop
DNA mutants of E. coli cease replication immediately when the temperature
is increased to 42°C.
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Pharmaceutical Abbreviations
| Abbreviations in product
information leaflets and literature
Acronyms | Glossary
of Terms | Abbreviations
used in the British Pharmaceutical