Common Standards for RIMS - Revision history

Khoppenworth at 15:09, 6 February 2024

2024-02-06T15:09:23Z

← Older revision		Revision as of 15:09, 6 February 2024
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	== Background ==		== Background ==
	Through a consultative proces an international team is recommending that the ~~following~~ standards are considered for inclusion in an RIMS design:		Through a consultative proces an international team is recommending that the below listed minimum standards are considered for inclusion in an RIMS design.

			A thorough report is available in the report ''"USAID MTaPS and PQM+ Programs. Pathway to Digitalize Regulatory Information Management Systems for National Medicines Regulatory Authorities in Low- and Middle-Income Countries. Submitted to the US Agency for International Development by the USAID PQM+ and MTaPS Programs."''

	== Process Standards ==		== Process Standards ==

Khoppenworth: Khoppenworth moved page International Standards Process to Common Standards for RIMS without leaving a redirect

2023-07-20T18:37:34Z

Khoppenworth moved page International Standards Process to Common Standards for RIMS without leaving a redirect

← Older revision	Revision as of 18:37, 20 July 2023
(No difference)

KhoppenworthMSH: New Page

2022-06-23T16:56:27Z

New Page

New page

== Background ==
Through a consultative proces an international team is recommending that the following standards are considered for inclusion in an RIMS design:

== Process Standards ==
{| class="wikitable"
|Good Laboratory Practices (GLP)
|-
|Monographs
|-
|ISO 9001:2015 - Quality Management System Procedures
|-
|Good Distribution Practices (GDP)
|-
|ISO 17025:2017
|-
|Good Practices For Pharmaceutical Quality Control Laboratories
|-
|Good Clinical Practice (GCP)
|-
|Good Manufacturing Practices (GMP) or ICH Q7
|-
|Good Practices For Pharmaceutical Microbiology Laboratories
|-
|Good Review Practices (GRevP)
|-
|Good Storage Practices (GSP)
|-
|ICH Q10
|-
|Good Pharmacovigilance Practices
|}

== Dictionaries & Knowledge Trees ==
{| class="wikitable"
|International Nonproprietary Names (INN)
|-
|Anatomical Therapeutic Chemical Index (ATC)
|-
|WHODrug Global
|-
|National Drug Code (NDC)
|-
|The Medical Dictionary for Regulatory Activities (MedDRA)
|-
|Chemical Abstracts Service (CAS) registry number
|-
|Unique Ingredient Identifier (UNII)
|-
|ISO 11238 Substance Identification (SubID)
|-
|GS1 Standards
|-
|ISO 11615 Medicinal Product Identification (MPID)
|}

== Data Exchange Standards ==
{| class="wikitable"
|Portable Document Format (PDF)
|-
|XML
|-
|Common Technical Document (CTD)
|-
|E2B - Pharmacovigilance: Individual Case Safety Reports (ICSR) or ISO/HL7 27953-2:2011
|-
|Structured Product Labelling (SPL)
|-
|Fast Healthcare Interoperability Standards (FHIR)
|}