Pharm Vocab

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Anonymous
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37297
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Pharm Vocab
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2010-09-25 19:54:41
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Pharm Vocab
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Pharm Vocab
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  1. Active ingredient
    Any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body of man or other animals.
  2. Batch
    A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture.
  3. Batchwise control
    The use of validated in-process sampling and testing methods in such a way that results prove the process has done what it purports to do for the specific batch concerned.
  4. Certification
    Documented testimony by qualified authorities that a system qualification, calibration, validation, or relavidation has been performed appropriately and that the results are acceptable.
  5. Compliance
    Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices.
  6. Component
    Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product.
  7. Drug product
    A finished form that contains an active drug and inactivee ingredients. This term may also include a form that does not contain an active ingredient, such as a placebo.
  8. Inactive ingredient
    Any component other than the active ingredients in a drug product.
  9. Lot
    A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number.
  10. Lot number/control number/batch number
    Any distinctive combination of letters, numbers, or symbols, from which the compplete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined.
  11. Master record
    Record containting the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product.
  12. Quality assurance
    Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately.
  13. Quality audit
    A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.
  14. Quality control
    The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference.
  15. Quality control unit
    An organizational element designed by a firm to be responsible for the duties relating to quality control.
  16. Quarantine
    An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use.
  17. Representative sample
    A sample that accurately portrays the whole.
  18. Reprocessing
    The aactivity whereby the finished product or any of its components is recycled through all or part of the manufacutring process.
  19. Strength
    The concentration of the drug substance per unit dose or volume.
  20. Verified
    Signed by a second individual or recorded by automated equipment.
  21. Validation
    Documented evidence that a system (equipment, software, controls) does what it purports to do.

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