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FAQs: USP Changes <61> and <62> - Effective May 1, 2009

  1. Do I need to revalidate?
  2. Should I revalidate before May 1, 2009?
  3. Under the Harmonized <61> and <62> chapters what are the changes and how do they affect my product?
  4. Will there be changes in Turn Around Time (TAT) offered by Celsis?
  5. Will the sample quantity needed for testing change?
  6. If I am submitting testing for the Harmonized chapters USP <61> and <62> what should I indicate on the sample submission form?
  7. What is chapter <1111>?

  1. Do I need to revalidate?

    Yes, as of May 1, 2009 the Current USP <61> chapter will become obsolete and is being replaced with a NEW Harmonized procedures chapter <61> and <62>. Some exception is being made for sample materials on stability. Please contact the FDA regarding their requirements for materials on stability deemed as “Put on Station at the Time”.

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  2. Should I revalidate before May 1, 2009?

    Yes, if at all possible you should revalidate in advance to insure your products are validated prior to the changes taking effect on May 1, 2009.

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  3. Under the Harmonized <61> and <62> chapters what are the changes and how do they affect my product?
    •   Aerobic Plate Count (APC) and Yeast/Mold have changed to Total Aerobic Plate Count (TAPC) and Total Yeast and Mold Count (TYMC). There are changes regarding organisms required and incubation requirements.
    • E. coli, Salmonella, P. aeruginosa & S. aureus enrichments have changes regarding dilutent, media, dilutions and incubation requirements.
    • Bile-Tolerant GNB, Clostridia and C. albicans have been added for “specific” types of materials.

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  4. Will there be changes in Turn Around Time (TAT) offered by Celsis?

    No, we will still be able to offer the same TAT; 10-Business Days and 5-Business Days Express (dependant on Suitability passing).

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  5. Will the sample quantity needed for testing change?

    Yes, under the new Harmonized method different sample sizes may be required for both Routine and Suitability Testing. For instance, samples submitted for TAMC, TYMC, E. coli, Salmonella, Pseudomonas and Staphylococcus for routine and suitability testing will require a minimum of 30 grams of material. The addition of Bile Tolerant Gram Negative bacteria may require an additional 10 grams depending on the method. Please feel free to contact the laboratories to verify the amount of sample required for your product. 

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  6. If I am submitting testing for the Harmonized chapters USP <61> and <62> what should I indicate on the sample submission form?
    • Tests to be conducted; List each organism you want tested which you will need to determine internally per your Regulatory Department.
    • Method; USP 31 Harmonized or USP 31 <61/62> Harmonized – Please be sure to state the word “Harmonized”.
    • Limits; Suitability testing Limits are always “Report Results”. Routine testing Limits for TAMC and TYMC would need to be supplied by client or released as “Report Results” and the Enrichments are always reported as “Absent”.

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  7. What is chapter <1111>?

    This chapter is a guidance for manufactures when deciding on testing required for their materials. Celsis does not use this chapter when testing samples it is up to the client to make the appropriate decision what testing they require prior to submitting samples for testing.

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