Bioequivalence and Bioavailability Forum • OECD GLP

OECD GLP [Bioanalytics]

posted by Helmut – Vienna, Austria, 2015-02-13 15:13 (3754 d 05:52 ago) – Posting: # 14416
Views: 11,758

Hi ElMaestro & Jan,

❝ I wonder if the standards have any use at all for BA/BE GLP analyses then.

GLP? Interesting to read in the OECD Principles on Good Laboratory Practice, Section II 4.4.:

Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.

(my emphasis)
May we conclude: If the concentration is not given = not appropriate = don’t worry = still in accordance with OECD’s GLP? Strange.

On the other hand Section II 6.2.2.

For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.

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Complete thread:

Reference standards janmacek 2015-02-13 10:57
- Reference standards ElMaestro 2015-02-13 11:51
  - OECD GLPHelmut 2015-02-13 14:13
  - Reference standards Ionsource 2015-02-16 08:04
- Reference standards Ohlbe 2015-02-13 15:49
  - Reference standards nobody 2015-02-13 19:22
    - Reference standards ElMaestro 2015-02-13 23:00
      - ....got a wicked idea ElMaestro 2015-02-13 23:18
        
        ....got a wicked idea nobody 2015-02-14 12:49
  - Reference standards janmacek 2015-02-16 12:59
    - Reference standards janmacek 2015-07-15 09:28
      - "solved" ??? ElMaestro 2015-07-15 10:35