1. GMP and Pharmacopoeia: Harmonisation of Basic Regulators’ Tools
Dr.-Ing. Stephan Roenninger
Amgen (Europe) GmbH Director, External Affairs

2. Manufacturing Techniques and Regulatory Expectations for Medicines Have Increased over the Years - Harmonisation is Regarded Beneficial
1880
1970
2010
2020
Tomorrow ?
1405
1516
1866
1949
1970
1990
2010
Regulatory requirements

3. The Complexity of the Responsibilities Drive the Need for Collaboration Among Different Actors in the Regulatory System
Ministry of Health
III. GMP conference 2018
Opportunities to seek advice from other actors in the regulatory field
Registration
Russian Accreditation Service (Min. Economic Developm.)
Ministry of Industry & Trade (MinPromTorg)
Testing requirements
Licensing of Manufacturing
Certification Authorities & Testing labs (‚Notified body’)
Federal Service of Surveillance of Healthcare
Registration testing
Pharmaceutical License Surveillance testing
State Institute of Drugs and Good Practices (Notified Body)
GMP Inspections
E. Meyers, N. Parfenova, S. Rönninger, Manufacturers Face Certification, Licensing Steps in Russia, PDA letter, January, 2014,

4. Awareness of Innovation and Modern Manufacturing Can Provide Input to Inspections
Capability of the manufacturing process
Adequacy of production & control procedures
Suitability of equipment and facilities
Effectiveness of the Quality Management System (QMS)
Opportunities for continuous improvement on regulatory expectations
Inspections

5. Potential Consequences:
There is Overlap of Regulatory Oversight which Can put Additional Testing in Question
Potential Consequences:
Delayed Access
Recall
Shortage
Resource hungry
Registration ?
Level of additional detail*
Registration testing ?
GMP Inspections . ?
Import testing ?
Surveillance testing ?
*(Analytical) Normative Document

6. Risk Based Approaches Can Help to Gain More Knowledge, When Relying on Inspections Performed by Recognized Inspectorates ?
Risk-based inspection planning PIC/S guideline PI 037-1, 1 January 2012
GMP-Inspection reliance, PIC/S guideline PI 048-1, 1 June 2018
Classification of GMP Deficiencies, PIC/S guideline PI 040-1, 1 January 2019

7. Opportunity to better informed decisions
Inspection Management Can be a Transparent Process Supporting Informed Regulatory Decision
GMP certificate for sites
Risk Management
Inspection
Share draft Report
CAPA by the site
Regulatory Decision
Reliance, remote (desktop) review
Duration & Focus
Frequency – Reinspection
Opportunity to better informed decisions
Risk-based inspection planning PIC/S guideline PI 037-1, 1 January 2012
GMP-Inspection reliance, PIC/S guideline PI 048-1, 1 June 2018
Classification of GMP Deficiencies, PIC/S guideline PI 040-1, 1 January 2019
A Concept for Harmonized Reporting of Inspections, EFPIA, position paper, 29. May 2015
Consider alternatives to a follow up inspections performed by different inspectors, on the full program and length

8. Supposed Legal Barriers can Demonstrate Opportunities on Inspections and Import Testing when Taking a Different Perspective

9. Supposed Legal Barriers can Demonstrate Opportunities on Inspections and Import Testing when Taking a Different Perspective
Ministry of Health
Registration
Russian Accreditation Service (Min. Economic Developm.)
Ministry of Industry & Trade (MinPromTorg)
Testing requirements
Licensing of Manufacturing
Certification Authorities & Testing labs (‚Notified body’)
Federal Service of Surveillance of Healthcare
For Patients
Registration testing
Pharmaceutical License Surveillance testing
State Institute of Drugs and Good Practices (Notified Body)
GMP Inspections
Acknowledgement: Elisabeth Meyers, Paul Lucas