HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-02-02

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 2, 2009

Attendees:

Attendees: Norman Gregory (CVM), Mai Huynh (CVM), Jonathan Cook (CDER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Jackline Mokaya (Phibro Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Diane Miller (Alpharma)

  • The major changes to the document are the Component #'s and Subject #'s.

Pharmaceutical Industry and anyone else, we could use your in put regarding examples (case studies) of cycled studies (see below):

  • We discussed having cycled studies examples (test cases) within one message (report). A cycled freeze/thaw study or stability of product after reconstitution (in use study) would be a separate message (report), not part of the same message. We need examples (case studies) of a product on stability and at a test station would have something else done to it and tested at an interval (e.g., sample is draw at 6 month test station and tested, then that same sample has something done and is tested at 1, 5 and 10 minutes).

Please give examples of the above

  • Revised the IG for the attribute ExpirationTime under ManufactureMaterial (page 36) to read "Date of expiration (based on the provided expirationCode of the “Product” element) or the proposed expiration date of the material. Interpretation for a product: if an interval value is provided this means that this is a proposed Expiration date, if a date value is provided this is the already approved expiration date. Interpretation for “substances” (i.e. intermediates or APIs): if an interval value is provided this means that this is a proposed retest period, if a date value is provided this is the already approved retest date.
  • I believe we got to Section 4.20 (page 25) of the Input Tool User Requirement Document.
  • For this next cycle (January to May), there will be no teleconference Monday February 16th..

Agenda for February 9, 2009 Teleconference:

  • Continue discussion regarding the Input Tool Requirements document, if ready.
  • Discuss the style sheet example.

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