From a37db0fa75e90fa3aee0f1b4ae493f07658e343c Mon Sep 17 00:00:00 2001 From: Elisa Kendall Date: Thu, 29 Dec 2022 20:57:10 -0800 Subject: [PATCH 1/5] IDMP-387 - extended the medicinal products ontology to include a number of bridge concepts required for UC-2, CQ-1, including process, process step, batch, lot, and a number of subordinate concepts and related identifiers Signed-off-by: Elisa Kendall --- ISO/ISO11615-MedicinalProducts.rdf | 295 +++++++++++++++++++++++++++-- 1 file changed, 282 insertions(+), 13 deletions(-) diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index 98b269dc..aca992f2 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -90,8 +90,8 @@ - - The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221001/ISO11615-MedicinalProducts.rdf version of this ontology was modified to rename 'ingredient role's to ingredients for clarification and refine the restrictions relating ingredients to pharmaceutical products and manufactured items per discussion at the Pistoia Alliance Conference Workshop on 3 November 2022 (IDMP-298). + + The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221001/ISO11615-MedicinalProducts.rdf version of this ontology was modified to rename 'ingredient role's to ingredients for clarification and refine the restrictions relating ingredients to pharmaceutical products and manufactured items per discussion at the Pistoia Alliance Conference Workshop on 3 November 2022 (IDMP-298). It was also extended to include concepts such as process, manufacturing process, process identifier, batch, batch identifier, lot, lot number, and others required in support of the regulatory to manufacturing bridge use case. Copyright (c) 2022 EDM Council, Inc. Copyright (c) 2022 Pistoia Alliance, Inc. @@ -347,6 +347,18 @@ + + + + + + + + + + + + @@ -354,23 +366,37 @@ batch - ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.8 - specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture + 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 batch process + The restriction with respect to matter should be revised or augmented to define a specific amount (or amounts) of matter used to produce the batch. + + - - - + + - - - 1 + + - batch identifier - ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.9 - identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of time + batch number + identifier assigned to a specific batch of material that is being produced or that has been produced by a single execution of a batch process + + + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) + batch identifier + + + + + batch process + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.8) + 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 using one or more pieces of equipment + This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). + Batch processes are discontinuous processes, which are neither discrete nor continuous but have characteristics of both. + @@ -457,6 +483,26 @@ The ISO 11615 definition for 'container' is too specific to be a generalization of some of its subordinate concepts, such as intermediate container and other packaging related concepts. + + + continuous process + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.2) + process in which materials are passed in a continuous flow through processing equipment + This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). + Once established in a steady operating state, the nature of the process is not dependent on the length of time of operation. Start-ups, transitions, and shutdowns are usually treated as separate activities and do not necessarily contribute to achieving the desired processing. + + + + + + discrete process + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.3) + process in which a specified quantity of parts moves as a unit (group of parts) between workstations and each part maintains its unique identity + This is a starting point that requires extension to include further axioms including relationships with input and output materials, specific quantities thereof, production lots, and so forth, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). + Products are classified into production lots that are based on common raw materials, production requirements, and production histories. + + + ISO 20443 code set @@ -688,6 +734,39 @@ IMPID + + + + + + + + + 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 + This is preliminary and needs extension to specify common characteristics of a given lot. + As defined in ANSI/ISA-95 and IEC 62264-1 as material lot: uniquely identifiable amount of a material. + Some examples of common traits are material source, the master recipe used to produce the material, and distinct physical properties. + + + + + + + + + + + + batch number + identifier assigned to a unique amount of material having a set of common traits + + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.32) + lot ID + lot identifier + + @@ -720,6 +799,16 @@ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.39 + + + manufacturing process + ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.15 + structured set of activities or operations performed upon material to convert it from the raw material or a semifinished state to a state of further completion + This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). + Manufacturing processes may be arranged in process layout, product layout, cellular layout or fixed position layout. Manufacturing processes may be planned to support make-to-stock, make-to-order, assemble-to-order, etc., based on strategic use and placements of inventories. [SOURCE:ISO 15531-1] + + + @@ -820,6 +909,56 @@ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.50 + + + + + + + + + + + + + + + + medicinal product batch identifier for immediate packaging + ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.52 + unique identifier allocated to a specific batch of a medicinal product, which appears on the immediate packaging, where this is not the outer packaging + For more explicit modeling of the semanitics we should consider creating a property chain that links the BAID1 through the pharmaceutical product batch identifier, through the pharmaceutical product batch to its expiration date rather than using a disconnected date (future update). + It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product based at the level of the immediate container. + + BAID2 + medicinal product batch identifier 2 + + + + + + + + + + + + + + + + + + medicinal product batch identifier for outer packaging + ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.51 + unique identifier allocated to a specific batch of a medicinal product, which appears on the outer packaging of the medicinal product + For more explicit modeling of the semanitics we should consider creating a property chain that links the BAID1 through the pharmaceutical product batch identifier, through the pharmaceutical product batch to its expiration date rather than using a disconnected date (future update). + It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product at the package level. + + BAID1 + medicinal product batch identifier 1 + + @@ -855,6 +994,17 @@ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.53 + + + medicinal product manufacturing process + ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.40 + process of production for a substance or medicinal product from the acquisition of all materials through all processing stages + This is a starting point that requires extension to include additional relationships as described in the note. + The critical process, critical process steps, starting and processing materials and critical production parameters are included. + + manufacturing + + @@ -963,6 +1113,53 @@ ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.60 + + + + + + + + + + + + + + + + + + + + + + + + + + + pharmaceutical product batch + ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.8 + specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture + This definition of batch entails axioms relating the batch to a manufacturing order and identifying the manufacturing cycle, which need to be added. + + + + + + + + + + + + pharmaceutical product batch number + ISO 11615:2017 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.1.9 + identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing process at a specific point of time + + + @@ -993,6 +1190,58 @@ strength (presentation) + + process + ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21 + structured set of activities involving various enterprise entities, that is designed and organized for a given purpose + This is a starting point that requires extension to include the activities that comprise the process, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). + The definition provided here is very close to that given in ISO 10303-49. Nevertheless ISO 15531 needs the notion of structured set of activities, without any predefined reference to the time or steps. In addition, from the point of view of flow management, some empty processes may be needed for a synchronisation purpose although they are not actually doing anything (ghost task). [SOURCE:ISO 15531-1] + + + + + + + + + + + + process identifier + identifier assigned to a structured set of activities involving various enterprise entities, that is designed and organized for a given purpose + + ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21 + + + + + + + + + + + process step + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) + part of a process that usually operates independently from other process stages and that usually results in a planned sequence of chemical or physical changes in the material being processed + Note that this is an early representation of the concept only, and will likely require extension in future releases. + + + + + + + + + + + + process step identifier + identifier assigned to a part of a process + + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) + + @@ -1305,6 +1554,14 @@ indicates the situation that faciliates endorsement of the authorized party for some purpose + + + is batch of + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) + + is produced or has been produced by a single execution of a batch process + + @@ -1329,6 +1586,18 @@ is held within its volume or area and is in direct contact with + + + is input to + is put in, taken in, or operated on by + + + + + is output of + is produced by or results from some process, process step, action, activity, or other effort + + manages administration of From 482674b0b91979ec011174b249b7aea5347f59f5 Mon Sep 17 00:00:00 2001 From: Elisa Kendall Date: Thu, 29 Dec 2022 22:07:58 -0800 Subject: [PATCH 2/5] IDMP-387 - addressed hygiene issues Signed-off-by: Elisa Kendall --- ISO/ISO11615-MedicinalProducts.rdf | 10 +++++----- 1 file changed, 5 insertions(+), 5 deletions(-) diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index aca992f2..eb0b5a73 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -367,7 +367,7 @@ 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 batch process + material that is being produced or that has been produced by a single execution of a 'batch process' The restriction with respect to matter should be revised or augmented to define a specific amount (or amounts) of matter used to produce the batch. @@ -497,7 +497,7 @@ discrete process ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.3) - process in which a specified quantity of parts moves as a unit (group of parts) between workstations and each part maintains its unique identity + process in which a specified quantity of parts moves as a unit (group of parts) between workstations and each part maintains its unique identity This is a starting point that requires extension to include further axioms including relationships with input and output materials, specific quantities thereof, production lots, and so forth, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). Products are classified into production lots that are based on common raw materials, production requirements, and production histories. @@ -759,7 +759,7 @@ - batch number + lot number identifier assigned to a unique amount of material having a set of common traits ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.32) @@ -1192,7 +1192,7 @@ process - ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21 + ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21 structured set of activities involving various enterprise entities, that is designed and organized for a given purpose This is a starting point that requires extension to include the activities that comprise the process, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). The definition provided here is very close to that given in ISO 10303-49. Nevertheless ISO 15531 needs the notion of structured set of activities, without any predefined reference to the time or steps. In addition, from the point of view of flow management, some empty processes may be needed for a synchronisation purpose although they are not actually doing anything (ghost task). [SOURCE:ISO 15531-1] @@ -1210,7 +1210,7 @@ process identifier identifier assigned to a structured set of activities involving various enterprise entities, that is designed and organized for a given purpose - ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21 + ISO 18629-11:2005(en) Industrial automation systems and integration — Process specification language — Part 11: PSL core - https://www.iso.org/obp/ui/#iso:std:iso:18629:-11:ed-1:v1:en, clause 3.1.21 From 92c954694783ac939ee6128ccaac238c5ddaac92 Mon Sep 17 00:00:00 2001 From: Elisa Kendall Date: Thu, 29 Dec 2022 22:37:33 -0800 Subject: [PATCH 3/5] IDMP-387 - revised the definition of batch to include most of the definition of 'batch process' rather than the term, batch process, to address a hygiene issue that likely needs revision to allow for compound terms that appear elsewhere in the ontology and that use the term in question Signed-off-by: Elisa Kendall --- ISO/ISO11615-MedicinalProducts.rdf | 4 ++-- 1 file changed, 2 insertions(+), 2 deletions(-) diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index eb0b5a73..f1309cd4 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -367,8 +367,8 @@ 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 'batch process' - The restriction with respect to matter should be revised or augmented to define a specific amount (or amounts) of matter used to produce the batch. + 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 + The restriction with respect to matter should be revised or augmented to define a specific amount (or amounts) of matter used to produce the batch. Also note that in order to shorten the definition to use the term 'batch process' in place of most of the definition of a batch process requires loosening the constraint on circular definitions, or creating an exception for a compound term where that term appears in a different label in the ontology. From 998b834c1fe0f99deeb52a12a329cf1bfecd1833 Mon Sep 17 00:00:00 2001 From: Elisa Kendall Date: Fri, 30 Dec 2022 11:00:58 -0800 Subject: [PATCH 4/5] IDMP-387 - renamed subclasses of manufacturing process to include 'manufacturing' per feedback Signed-off-by: Elisa Kendall --- ISO/ISO11615-MedicinalProducts.rdf | 35 ++++++++++++++++-------------- 1 file changed, 19 insertions(+), 16 deletions(-) diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index f1309cd4..bc153bb1 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -356,7 +356,7 @@ - + @@ -373,6 +373,17 @@ + + + batch manufacturing process + ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.8) + 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 using one or more pieces of equipment + This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). + Batch processes are discontinuous processes, which are neither discrete nor continuous but have characteristics of both. + + batch process + + @@ -389,16 +400,6 @@ batch identifier - - - batch process - ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.8) - 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 using one or more pieces of equipment - This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). - Batch processes are discontinuous processes, which are neither discrete nor continuous but have characteristics of both. - - - @@ -483,24 +484,26 @@ The ISO 11615 definition for 'container' is too specific to be a generalization of some of its subordinate concepts, such as intermediate container and other packaging related concepts. - + - continuous process + continuous manufacturing process ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.2) process in which materials are passed in a continuous flow through processing equipment This is a starting point that requires extension to include further axioms including relationships with input and output materials, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). Once established in a steady operating state, the nature of the process is not dependent on the length of time of operation. Start-ups, transitions, and shutdowns are usually treated as separate activities and do not necessarily contribute to achieving the desired processing. + continuous process - + - discrete process + discrete manufacturing process ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 4.2.3) process in which a specified quantity of parts moves as a unit (group of parts) between workstations and each part maintains its unique identity This is a starting point that requires extension to include further axioms including relationships with input and output materials, specific quantities thereof, production lots, and so forth, derived from ANSI/ISA S88 and the ISO Process Specification Language (PSL). Products are classified into production lots that are based on common raw materials, production requirements, and production histories. + discrete process @@ -1558,7 +1561,7 @@ is batch of ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) - + is produced or has been produced by a single execution of a batch process From bc15d5c9ff6cd551cf6830c5a7bd063d41a88745 Mon Sep 17 00:00:00 2001 From: Elisa Kendall Date: Fri, 30 Dec 2022 11:32:06 -0800 Subject: [PATCH 5/5] IDMP-387 - simplified the definition of batch to use isConstituentOf vs a new isBatchOf property Signed-off-by: Elisa Kendall --- ISO/ISO11615-MedicinalProducts.rdf | 28 ++++++++++------------------ 1 file changed, 10 insertions(+), 18 deletions(-) diff --git a/ISO/ISO11615-MedicinalProducts.rdf b/ISO/ISO11615-MedicinalProducts.rdf index bc153bb1..bfbd3a31 100644 --- a/ISO/ISO11615-MedicinalProducts.rdf +++ b/ISO/ISO11615-MedicinalProducts.rdf @@ -347,12 +347,6 @@ - - - - - - @@ -365,6 +359,12 @@ + + + + + + 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 @@ -1120,14 +1120,14 @@ - - + + - - + + @@ -1557,14 +1557,6 @@ indicates the situation that faciliates endorsement of the authorized party for some purpose - - - is batch of - ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6) - - is produced or has been produced by a single execution of a batch process - -