QUIZ #3: cGMPs in the Pharmaceutical Laboratory
Part One: USP General Notices


Answer each of the following questions with a short response. Good luck!

  1. What is the minimum acceptable standard grade for laboratory chemicals (reagents, not analytical standards) used in the conduct of USP tests and assays?
  2. When an individual monograph specifies a certain apparatus by commercial name, when is it acceptable to use a different apparatus?
  3. Is it necessary to identically prepare test and assay solutions as per the monograph at all times? If not, please elaborate on any alternatives.
  4. If an in-house FDA-approved alternate method of analysis is used to analyze a compendial article and a question as to the integrity of the result is raised, which test method is accepted as being the authoritative (or conclusive) one - USP or FDA-approved alternative?
  5. When is it necessary to dry a USP standard before using it to perform an assay?
  6. Does the term "transfer" indicate quantitative or qualitative manipulation of a substance?
  7. Define the term "concomitant".
  8. When it is necessary to accurately weigh a material, what defines a suitable balance? That is, how accurate does the balance have to be in the respective weight range to be considered suitable for use?
  9. When performing titrations, what percentage of the Buret volume must be used per trial to produce an acceptable result?
  10. Define the term "dried to constant weight" as it relates to compendial tests.
  11. Define the term "ignite to constant weight" as it relates to compendial tests.
  12. When using a test solution as an indicator for a test or assay, what amount (mLs or drops) is generally to be used?
  13. Define the term negligible as it applies to the Pharmacopoeia.
  14. Define the following expression: (92:25:4:2).
  15. What does the expression (1 in 9) mean?
  16. What do the following abbreviations stand for:
    "VS"
    "TS"
  17. What type of water is to be used in tests and assays where water is called for?
  18. When you are directed to "filter" a liquid, without further qualification, the intent is that the liquid be filtered through suitable filter paper or equivalent device until the filtrate is _____________.
  19. Terms related to the "Odor" of an article refer to the article after exposure to _____ for _____ minutes.
  20. What does the term "about" mean in relation to the USP?

How did you do? After you have taken the Quiz, request the answers via E-mail from accureg@regulatory.com. If you include your address, we'll send you a pocket book of the GMPs for Medical Devices or for finished Pharmaceuticals!

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