staying ahead of the curve in an increasingly complex...
TRANSCRIPT
![Page 1: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/1.jpg)
Staying Ahead of the Curve in an Increasingly Complex Regulatory World as seen from Novo Nordisk A/S, a global pharmaceutical manufacturer
Søren Thuesen Pedersen, Novo Nordisk A/S
![Page 2: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/2.jpg)
The External Requirement Process
Capture of new requirements
Pre-analysisCapture of
industry practice trends
Capture of regulator
expectations
AnalysisPlanning (of
implementation)Implementation &
Report
Influence
Formal HandoverTo Process
Organisation
25 Focus Groups Line of Business (Process Groups)
Process landscape
![Page 3: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/3.jpg)
EudraLex Vol 4 EU - GMP
GMP Directive for MP(Directive 2017/1572, 15. Sept 2017)
Treaty of the EU and
European Community(2007/C 306/01)
Chapter 1-9ICH Q7
includes GDP for APIs(ICH Q9 principles added)
GMP for ExcipientsICH Q9, ICH Q10, SMF, Batch
certificate, API conf.
GDP for MP & API guidelines;Inspections: Compilation of
commutiy procedures
MP: Medicianl Product
red: medicinal product,
blue: API; brown: GDP
green: in consutat ion
Sec
onda
ry L
aw (‘
leve
l 1’)
Reg
ulat
ory
stat
utes
Community code Medicinal products for human use
(Directive 2001/83/EC)
Prim
ary
Law
Authorization: Art 40
GMP: Art 47
Saftey features: Art 54a(2)
GDP: Art 84
Art 168(4)(a)Art. 114
& 168(4c)
GDPAPI Excipients
Art 63(4) Inspections
Safety feature
Falsified Medicines Dir (Directive 2011/62/EC)
New EC gui (ex Annex 13; 24.11.15)
amending
Art. 95 &
152(4)(b)
Sec
onda
ry L
aw (‘
leve
l 2’)
Manufacturing of Med.Dev ISO13485, EC Mark (Directive 93/68/EEC),
‘Blue Guide’ ECnotice 2016/C 272/01
Medical Device Regulation (Regulation 2017/745, 05. April 2017)
(9) authorisation; (17) GMP; (21) IMP-GMP
Advanced Therapy MP(Regulation EC 1394/2007)
Art 5. GMP for ATMP
Specific APIs or therapies, specific conditions, supporting GMP processes, procedural gui, enablers
Part II
GMP Active Substances as starting material (incl. GDP)
Part I
GMP Medicinal Product(i.e. drug products)
Part III
GMP related
documents
Other Documents
Related to GMP(incl. e.g. Inspections, Certificat ion)
Stephan Rönninger, Amgen, 22.12.2017
Chapter 1-9
Regulation on safety features (Delegated regulation 2016/161, 02 Oct 15)
* Guidance exists; see ’Others’
(comp. of comm.procedures)
GMP for IMPs GMP for Active Substances (Regulation No 1252/2014)
Art 63(1) GMP IMP
Clinical Trials RegulationRegulation 536/2014
Pharmacovigilance(Regulation 520/2012)
amending
Art 93
also: Food law (Reg
EC No 178/2002) and
Cosmetics (Reg EC
No 1223/2009)
Authorisation of MP(Regulation 726/2004)
GMP Regulation for IMP(Delegated regulations 2017/1569, 23 May 17)
In vitro diagnostic MD reg
(Regulation 2017/746, 05. April 2017)
EC guidelines:GMP for IMPs
Annexes 1-13-17, 19, 21, 18 (ex ICH Q7), 20 (ex ICH Q9)
Existing gui
GMP for ATMPs (gui C(2017) 7694)
Part IV
GMP for ATMPs
documents
Example EU-GMPs: Legal System
![Page 4: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/4.jpg)
New Requirements
• There are 48 pharmacopoeias
• 20 sets of GMP regulation
• EU-GMP; EudraLex
• 21CFR11
• ISO
• OECD
• EAEU
Regulator expectations
• Novo Nordisk 60 inspections/year and
• 90 internal audits
Industry Practice Trends
• 250 + External representation seats
What are Compliance Signals?
Into OneQualityManagement System
![Page 5: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/5.jpg)
GMP Compliance Signals (2013-2019)
358
245
520469
424
522500
25
92 106 125
57 73 73
190
66 79 75
2013 2014 2015 2016 2017 2018 2019(Estimate)
Created Influenced Handed over
![Page 6: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/6.jpg)
FDA Quality Metrics
Continuous Manufacturing
EU Medical Device Regulation
MRA EU - Japan (biologics)
EAEU
Chinese Pharmacopeia 2020
ICH Q12
EU Annex 1
Novo Nordisk Monographs
Brexit
Quality Focus Areas2018-2019
We will always advocate for harmonization of regulatory requirements
Monitor Active
![Page 7: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/7.jpg)
• All external representation by Novo Nordisk is registered in TAR, the Trade Association Representation
• Create Synergy
• Training
External Representation
![Page 8: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/8.jpg)
My Take Home messages:
• Gives a good overview and confidence !• Somewhat laborious. • Senior Mgt. buy-in is critical
![Page 9: Staying Ahead of the Curve in an Increasingly Complex ...gosgmp.ru/download/Materialy/ivgmp/2019-09-24/01... · Capture of new requirements Pre-analysis Capture of industry practice](https://reader033.vdocuments.mx/reader033/viewer/2022050501/5f93f7c96e38c765ea20d2fc/html5/thumbnails/9.jpg)
Questions?