HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-06-15

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

June 15, 2009

Attendees:

Norman Gregory (CVM), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), Holly Settles (Elanco), Lauren Merrill (Genzyme) and Maje Nazim (Genzyme)

• I could not get the XForm from Jason to work using IE with the MozzIE add-on, it worked using Firefox with the Mozilla add-on, but does give an error. I will send screen shots to Jason.
• Terry demonstrated Input Tool using Adobe connect.
• Product/Substance - uses pick list for Specified Ingredient (the link for the codes is: UNIIs, Preferred Substance Names, and their Identified Synonyms). used pick list for Form (the link for the codes is http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm).
• Test Specification - uses pick list for Test Type and Method Type (defined in IG beginning on page 58).
• Test Specification and Lot Info - have check box for "Text is Link", a second line on the form will be added, one for the linked text and one for the free text.
• Study Info. - pick list for Container Type (the link for the codes is: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm163380.htm)

Along with the following:

Code	Display Name	Description
1	Dish, Petri	A shallow dish with a loose-fitting cover.
2	Plate, Microwell	Small volume multi-chambered plate (e.g. 96 well).
3	Canisters, lined	A type of lined can for holding a drug product.
4	Flask	Flat bottom bottle container or vessel.
5	Other

• Study Info. - pick list for Container Closure Type. The Closure Code does not have a link, but is in the IG and is the following:

Code	Display Name	Description
1	Child-resistant, Metal	Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly
2	Child-resistant, Plastic	Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly.
3	Continuous Thread, Metal	Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
4	Continuous Thread, Plastic	Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal.
5	Tamper-evident, Metal	A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal)
6	Tamper-evident, Plastic	A closure that shows the package has been opened and the product has been exposed to the outside environment.
7	Tamper-evident, Composite	Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened.
8	Vacuum, Metal	Metal closures used on packages where the pressure inside the package is less than atmospheric.
9	Vacuum, Plastic	Plastic closures used on packages where the pressure inside the package is less than atmospheric.
10	Vacuum, Composite	Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric.
11	Press-on/Twist-off, Metal	Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal.
12	Press-on, Composite	A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes.
13	Crown, Metal	A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4\" high when manufactured and does not have a rolled edge or wire. The crown is manufactured in 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish.
14	Lug, Metal	Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application.
15	Roll-on, Metal	A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread.
16	Flip-Top (Dispensing), Plastic	A hinged single or dual flap closure for controlled product dispensing.
17	Hinged (Dispensing), Plastic	A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice
18	Linerless, Plastic	A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish.
19	Pump (Dispensing), Plastic	Closure dispensing pumps are used to dispense product from containers
20	Push-pull (Dispensing), Plastic	A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway.
21	Snap-on Cap, Plastic	A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package.
22	Snip-tip (Dispensing), Plastic	Conical closure that is turned onto a container. The tip is cut off to open the container.
23	Toggle-swing (Dispensing), Plastic	A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position.
24	Trigger Sprayer (Dispensing), Plastic	Closured designed to dispense product from containers by spraying the product when a trigger is pulled.
25	Twist Open/Close (Dispensing), Plastic	Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container.
26	Valved (Dispensing), Plastic	Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open.
27	Stopper	Object used to plug opening of container.
28	Tie	Line, ribbon or cord used of fastening, or drawing the container closed.
29	Other

• Catherine showed the current Style sheet using Adobe connect.
• Opened file using Notepad to show Time units are hours and minutes, and period units are years, months, and weeks (user guide needs to indicated that the units should be the same per message).
• Expiration is listed as approved, proposed or not established.
• The model has expirationTime, existanceTime, and effectiveTime as and interval (IVL) which should have a <high>Value.
• Adobe connect will be available to use during all teleconferences.

Agenda for June 22, 2009 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Discuss the style sheet example.
• Input Tool documents.