AOAC SPADA Meeting

3/11/2020

CHALLENGES

 The working group had to focus on practices that could be maintained by a cross section of laboratories, from cGMP manufacturers to small academic laboratories.  The Guidelines are meant to work within the framework of existing standard practices that conform to ISO standards and even protect intellectual property.  Working with these boundaries- the guidelines stresses traceability between cultures using:

 Unique culture identifiers  Propagation history  Orthogonal testing

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CHALLENGES: CREATING A UNIQUE IDENTIFIER.

Challenge was that the format of the unique identifier could not be mandatory. • The unique IDs can be made at random or have embedded data in them- like date of manufacture or individual growing it or future storage location. • Smaller production facilities, academic labs can resort to “smart numbers” that embed data. • Manufacturers may need to rely on system-generated, random lot numbers, to avoid duplicate lot numbers. Solution was to allow the culture producer to generate their own format.

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