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DEPARTMENT OF HEALTH
Medicines Regulatory Affairs
(Pharmaceutical & Related Product
Regulation & Management)
EDMS Workflow Specification and Software Configuration Project
Update
E Taute SAPRAA 21 Nov 2008
Slide 2
1 2 3 4
5
6
7
Software LicensesWorkflow Specifications
and Configutarion
Internal Testing
Pilot Testing
Deployment
Formal Windchill Training
(1-8)
Informal Windchill Training
(1-8)
Recruit & Train Dataprocessors
(1-8)
Document Storage(Paper)
(1-5)Document Scanning & Printing
(1-3)
Recruit Technical Experts
(1-8)
Server Network
(electronic storage)
(1-5)
Data Integration & Maintenance
(1-8)
8Help Desk & Stabilisation Support
Project ManagementScoping Workshop
Slide 3
EDMS Workflow Specification and Software Configuration Timeline
Project Phases (Deliverable) Date
Phase 1 – Assessment May 2008
Phase 2 – Design To-Be Environment July 2008
Phase 3 – Configuration November 2008
Phase 4 – Testing February 2009
Phase 5 – Implement/Operate May 2009
EDMS Workflow & Configuration Project
Slide 4
It is expected that the EDMS Project will provide the following within the scope of the configuration contract :
• Conformance to local regulatory requirements
• Ability to perform search and retrieval operations on the information stored in the system
• Ability to perform workflow management in-house
• Provide web-enabled centralised control
• Conform to international regulatory standards
• Conform to Government IT standards
• Provide necessary tools to perform publication of updated information on website
• Provide ability to maintain security/control via digital signatures
• Ability to deliver version and iteration control
• Provide a clear archiving strategy; and
• Accommodate paper-based submissions
EDMS Workflow & Configuration Project
Slide 5
• Workflow Configuration
• Document Configuration
• Scanning Capacity
• Training
• Information Management
• Data Management
• Change Management
• Human Resource Capacity Building
Current and Future Commitments
EDMS Workflow & Configuration Project
Slide 6
• International agency implementation & harmonization
• Local Industry acceptance with provisos
- security, compatibility, capacity
• Electronic process will satisfy environmental & archiving concerns
• Data integration
• Business Process Management (Standardisation and time-line control)
• Knowledge Management (Management reporting, supervision and efficiency)
• Format cross indexing (MBR1 MRF1 eCTD)
• Capacity building
EDMS Workflow & Configuration Project
Major IndicatorsMajor Indicators
Slide 8
Information Information DatabaseDatabase
& Licensing& Licensing
Evaluators (150)Evaluators (150)Evaluators (150)Evaluators (150)
MCC Chairpersons (24)MCC Chairpersons (24)MCC Chairpersons (24)MCC Chairpersons (24)
Manufacturers (300)Manufacturers (300)Manufacturers (300)Manufacturers (300)
SSEECCUURREE
FFIIRREEWWAALLLL
SSEECCUURREE
FFIIRREEWWAALLLL
Internet
WWW
InternetInternet
WWWWWW
Secure InformationSecure InformationAdaptersAdapters
PVPVMedunsaMedunsa
General PublicGeneral PublicGeneral PublicGeneral Public
PharmacistsPharmacists
MedicalMedicalDoctorsDoctors
Other HealthcareOther HealthcareProvidersProviders
EDMS
LaboratoryLaboratoryBloemfonteinBloemfontein
Software Software VendorsVendors
ADRADRCape TownCape Town
ExternalExternalNRA AgenciesNRA Agencies
SiamedZizoCam
Clinical Trials & PV
CIS
CO
netw
ork &
Ca
blin
g
192Kb Diginet Line
& ISDN Backup
High Security & Climate Control
& backup power
Registry
Gr Fl (3)
Registry
Gr Fl (3)
Cluster Mgmt
2nd Fl (5)
Cluster Mgmt
2nd Fl (5)
Ops & Admin
2nd Fl (7)
Ops & Admin
2nd Fl (7)
MER
11th Fl (6)
MER
11th Fl (6)
CT & E
12th Fl (8)
CT & E
12th Fl (8)
I & LE
13th Fl (8)
I & LE
13th Fl (8)
Enquiries
2nd Fl (1)
Enquiries
2nd Fl (1)
Scanning
2nd Fl (1)
Scanning
2nd Fl (1)
Security Control & Encryption
Video Conferencing
3 x ISDN
Video Conferencing
3 x ISDN
PVPVBloemfonteinBloemfontein
LaboratoryLaboratoryPotchefstroomPotchefstroom
MCC Board
12th Fl (1)
MCC Board
12th Fl (1)
MRA Network Topology
Slide 9
Delays and Problems• EU Funding
• Delay in award of contract and eventual sign-off
• Software funded by DoH
• Specialists for testing (implementation support) – Appointment not approved
• Data capturers not yet optimally utilised
• Server security
• Amendment Bill
EDMS Workflow & Configuration Project
Successes and Milestones• Windchill in Licensing up and running
• Hardware Audit Completed
• As-Is Process Maps completed
• To-be Process Maps completed
• Commenced with configuration
EDMS Workflow & Configuration Project
Why?
Harmonisation
To provide for a common format/template for the submission of information to the regulatory authorities in the 3 ICH regions + South Africa
• “Common Technical Document” signed-off by ICH in November 2000
Advantages / Objectives:• Resource saving for industry• Facilitate simultaneous submission in all the regions• Facilitate exchange of regulatory information• Harmonised format to be further supported by the eCTD• More efficient assessment, e.g. use of hyperlinks• Faster availability of new medicines
CTD / eCTDCTD / eCTD
EDMS Workflow & Configuration Project
However, CTD is only a FORMAT !
It’s not a “single” dossier, with a “single” content since
• Legal requirements differ in the regions
• ICH guidelines have not yet harmonised all requirements
• SA guidelines not all harmonised
• Pharmacopoeiae are not harmonised
CTD / eCTDCTD / eCTD
QualityOverall
Summary2.3
Non-clinicalOverview
2.4
ClinicalOverview
2.5
Non-clinicalSummaries
2.6
ClinicalSummary
2.7
Module 3
Quality3.0
Module 4Non-clinical
Study Reports4.0
Module 5Clinical
Study Reports5.0
Module 2
CTD Table of Contents2.1
CTD Introduction2.2
Module 1Regional
Information1.0
Module 2-5 CTD
Module 1:Not Part of the CTD Content to be determined by authorities
12
Module 2
EDMS Workflow & Configuration Project
Module 2Module 2
Modules 3 - 5
Modules 3 - 5
Heart of Dossier
MRF1
PART 2 Basis for Registration and Overview of Application
PART 2A Pharmaceutical and biological availabilityPART 2B SBRA
PART 2C Pharmaceutical Expert Report
PART2D Pre-Clinical Expert Report
PART 2E Clinical Expert Report
CTD
Module 2
Section 2.3 Quality Overall Summary
Section 2.4 Nonclincial Overview
Section 2.6 Nonclinical Written and Tabulated Summaries
Section 2.5 Clinical Overview
Section 2.7 Clinical Summary
Technical “part” of Dossier
MRF1PART 3 Pharmaceutical & Analytical
PART 3A: Active Pharmaceutical Ingredient (API)
PART 3B: Formulation
PART 3C: Specifications & Control Procedures for Pharmaceutical Ingredients
PART 3D: Container & Packaging Materials
PART 3E: Manufacturing Procedure
PART 3F: Final product Specifications & Control
PART 3G: Stability Data of the Finished Pharmaceutical Product (FPP)
PART 3H: Pharmaceutical Development
PART 3I: Expertise and premises used for the Manufacture of a Biological Medicine
CTDModule 3
3.2.S Drug substance
3.2.P Drug Product
3.2.P.1 Description and composition of the drug
3.2.S.4 Control of Drug Substance
3.2.P.4 Control of Excipients
3.2.P.7 Container Closure System
3.2.P.3 Manufacture
3.2.P.5 Control of Drug Product
3.2.P.8 Stability
3.2.P.2 Pharmaceutical Development
MRF1
PART 3 Pharmaceutical & Analytical
PART 3A: Active Pharmaceutical Ingredient (API)
PART 3B: Formulation
PART 3C: Specifications & Control Procedures for Pharmaceutical Ingredients
PART 3D: Container & Packaging Materials
PART 3E: Manufacturing Procedure
PART 3F: Final product Specifications & Control
PART 3G: Stability Data of the Finished Pharmaceutical Product (FPP)
PART 3H: Pharmaceutical Development
PART 3I: Expertise and premises used for the Manufacture of a Biological Medicine
CTD
Module 3
3.2.S Drug substance
3.2.S.4 Control of Drug Substance
3.2.P Drug Product
3.2.P.1 Description and composition of the drug
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
3.2.P.4 Control of Excipients
3.2.P.5 Control of Drug Product
3.2.P.6 Reference Standards or Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability
3.3 References
Technical “part” of Dossier