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32 Cards in this Set
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- Back
- 3rd side (hint)
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Recognized as a major industry which requires a clearly defined organization |
Pharmaceutical and cosmetic manufacturing |
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2 offices under Scientific VP |
R & D QC |
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4 offices under Manufacturing VP |
Purchasing Production Warehouse Maintenance |
PPWM |
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The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product |
Manufacturing |
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Any organization or company involved in the manufacture |
Drug establishment |
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3 types of drug establishment |
Drug manufacturer Drug trader Drug distributor |
DDD |
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Engaged in operation involved in the production of a drug |
Drug manufacturer |
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Registered owner of the drug product but sub-contracts toll manufacturers |
Drug trader |
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May also engage in distribution and or marketing of its products |
Drugtrader |
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Imports or exports or finished products for its own use for wholesale distribution to other outlets |
Drug distributor |
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Any systematic process of checking to see to whether a product or service being developed is meeting specified requirements |
Quality assurance |
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Planned or systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled |
Quality assurance |
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Determination of adequate technical requirement of inputs and outputs |
Quality assurance |
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Testing of procured material for its conformance to established quality, performance, safety, and reliability standards |
QA |
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The observation techniques and activities used to fulfill requirements for quality |
QC |
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Combination of attributes or characteristics of a product, which when compared to a standard, serves as a basis for measuring uniformity of the product and determined its degree of acceptability |
Quality |
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It is everybody’s business |
Quality |
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Combination of administrative and technical procedures which must be used to produce and deliver a safe product to the end user |
QC system |
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5 QC manager |
Materials inspection section Analytical laboratory Biological testing laboratory Specifications and analytical development Quality coordinating office |
MABSQ |
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Sample and examine all raw materials received |
Materials inspection section |
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Sample and conduct physical test |
Materials inspection section |
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Maintain periodic examination on the quality of inventories throughout all phases of storage, shipping and distribution |
Materials inspection system |
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Perform an audit which is independent of the work done by production personnel |
Materials inspection section |
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Know the basic concepts of gravimetric and volumetric analysis |
Analytical laboratory |
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Handle different pharmaceutical instruments |
Analytical laboratory |
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Perform and evaluate microbiological assays |
Biological testing laboratory |
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Conduct environmental monitoring |
Biological testing monitoring |
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Coordinate with research, product development, and management towards improvement of a product |
Specs and analytical devt |
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Validate existing and tentative procedures of testing |
Specs and analytical devt |
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Develop new assay methods for in house use |
Specs and analytical devt |
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Should be accessible to all manufacturing and packaging operations |
Quality coordination office |
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Ha |
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