From 7887fca26ee149a229609f0636cedd8794beaf2d Mon Sep 17 00:00:00 2001 From: Elisa Kendall Date: Mon, 25 Sep 2023 09:15:46 -0700 Subject: [PATCH] IDMP-632 - revised the inheritance for Batch and Lot to subclass constituent rather than product Signed-off-by: Elisa Kendall --- ISO/ISO11615-MedicinalProducts.rdf | 18 +++++++++++++++--- 1 file changed, 15 insertions(+), 3 deletions(-) diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index f2e1a562..7a102b3f 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -109,7 +109,7 @@ The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230501/ISO11615-MedicinalProducts.rdf version of this ontology was modified to (1) integrate content related to modifications from Figure 15 in ISO 11238 (IDMP-540), (2) support isotopes and nuclides as in ISO 11238, Figure 14 (IDMP-539), (3) integrate content related to therapeutic indications in ISO 11615 (IDMP-561), (4) clarify the definition of marketing authorization holder (IDMP-395), (5) refine restrictions between medicinal products and authorized medicinal products (IDMP-550), (6) aligne the ontology with the revised basis of strength pattern (IDMP-582), and (7) loosen a constraint on ingredient with respect to manufactured item (IDMP-602). The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230601/ISO11615-MedicinalProducts.rdf version of this ontology was modified to (1) make indication texts as nodes instead of literals (IDMP-591), (2) add the concept of shelf life / storage per Figure 11 in the ISO 11615 specification (IDMP-371), (3) add undesirable effect per Figure 14 in the ISO 11615 specification (IDMP-591), (4) rename 'has medical condition' to use a more aligned label with ISO 11615 (IDMP-591), (5) add the concept of route of administration (IDMP-614), and (6) integrate the refined pattern for controlled vocabularies (IDMP-533). The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230701/ISO11615-MedicinalProducts.rdf version of this ontology was modified to extend the definition of product role to relate to product specifications in addition to products (IDMP-633). - The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230801/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add other therapy specifics (IDMP-639), and to (1) reflect the migration of some content in Commons from the Parties and Situations ontology to a new Roles and Compositions ontology at OMG (IDMP-642), and (1) to rename cmns-doc;isSpecifiedBy to cmns-doc;isSpecifiedIn, (2) incorporate hasExpirationDate, which was simplified out of the OMG Commons ontology, and (3) to rename concepts including Quantity, QuantityValue, and QuantityValueRange to ScalarQuantity, ScalarQuantityValue, and ScalarQuantityValueRange per the Commons 1.1 release (IDMP-655). + The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230801/ISO11615-MedicinalProducts.rdf version of this ontology was modified to add other therapy specifics (IDMP-639), and to (1) reflect the migration of some content in Commons from the Parties and Situations ontology to a new Roles and Compositions ontology at OMG (IDMP-642), to (1) rename cmns-doc;isSpecifiedBy to cmns-doc;isSpecifiedIn, (2) incorporate hasExpirationDate, which was simplified out of the OMG Commons ontology, and (3) rename concepts including Quantity, QuantityValue, and QuantityValueRange to ScalarQuantity, ScalarQuantityValue, and ScalarQuantityValueRange per the Commons 1.1 release (IDMP-655), and to restructure the inheritance hierarchy with respect to Batch and Lot definitions (IDMP-632). Copyright (c) 2022-2023 EDM Council, Inc. Copyright (c) 2022-2023 Pistoia Alliance, Inc. @@ -663,7 +663,7 @@ - + @@ -682,6 +682,12 @@ + + + + + + batch ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) material that is being produced or that has been produced by a single execution of a process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time @@ -1513,13 +1519,19 @@ - + + + + + + + lot ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.32) unique amount of material having a set of common traits