19th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (GMP Part)

23-24 November 2016, Barcelona, Spain

Course No. 15334



Hélène Bruguera, EDQM, France
Brendan Cuddy, EMA, United Kingdom
Graeme McKilligan, MHRA, United Kingdom
Jean-Louis Robert, Chairman of the EMA QWG, United Kingdom
Richard M. Bonner, United Kingdom
Tom Buggy, DSM Corporate Operational Audit, The Netherlands
Graham Cook, Pfizer, United Kingdom
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Ralf Gengenbach, Gempex, Germany
Roisin Hickey, Hovione, Ireland
George Hartong van Lokven, Aspen Oss B.V., The Netherlands
Graca Mata, Hovione, Portugal
Rudy Peeters, Janssen Pharmaceutica, Belgien
Colin Rienewerf, Piramal, United Kingdom
Anthony Storey, Pfizer, United Kingdom
Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Hilde Vanneste, Janssen Pharmaceutica, Belgium
Lore Vignoli, Roquette Freres, France
Victoria Waddington, Macfarlan Smith Limited A Johnson Matthey Company, United Kingdom


he APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from FDA, EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.

The GMP Conference, of which the final part is a Joint GMP
& RA session, provides updates from recent authorities’ initiatives, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.

The conference will be opened by a presentation about how to manage an effective Quality Management system followed by a presentation about the Qualified Person’s role on ensuring GMP compliant manufacture of APIs. The following lectures are dedicated to the consequences arising from non GMP compliant manufacture of APIs, the FDA’s Quality Metrics program, quality risk management in global API supply chains and data integrity issues.

In the Joint GMP and Regulatory Affairs part of the conference you will hear presentations about the ICH Q11 regulatory starting materials Q&A, the new ICH Q12 guideline and its impact on post approval changes, combined play of GMP and regulatory aspects in the regulatory dossier and an update on EDQM’s activities.

The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to quality aspects of starting materials, GMP compliant API facility design and data integrity issues as well as current regulatory hurdles, practical experiences concerning GDUFA and ICH Q3D in connection with API manufacturers’ responsibilities.

The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.


GMP Conference
How to manage an effective Quality Management System
QMS - what does an inspector expect?
Areas of deficiency in current inspections
What industry should be doing to improve QMS and Quality culture
Graeme McKilligan, MHRA, United Kingdom

What keeps QPs awake at night from an API perspective
What are the regulatory expectations of a QP with respect to APIs - is this clear to all interested parties
What concerns have QPs on ensuring GMP compliant APIs
What can the QP and the API Industry do to ensure compliance
How does the globalisation of the API Industry impact QPs and what are the concerns
What can both parties do to ensure supply chain is robust and does not impact drug shortages
Richard M. Bonner, ECA, formerly with Eli Lilly, United Kingdom

Consequences of non GMP compliance
Non GMP compliant APIs – what can be the impact to API manufacturers?
What is causing licence withdrawals and drug shortages from non GMP compliant APIs ?
How is EU industry informed that such a supplier is non-compliant?
What can the API Industry do to prevent drug shortages?
What can the authorities do to aid API companies in ensuring supply chain is maintained?
Brendan Cuddy, Compliance and Inspection Sector, EMA, United Kingdom

An update on Quality Metrics (QM) program
Program overview – update
How API industry may help FDA
New guideline version
How different is it from the 1st draft?
How and when API industry will be involved
Which QM API industry will report?
How the QM now defined will fit the FDA program purpose
Implementation program

Quality (Risk) management in Global API Supply Chain
GxP regulations and guidelines to be considered
Characteristics and challenges of global supply chains
Managing logistic service providers
How to ensure Supply Chain transparency (incl. customer expectations)
Transport validation and risk assessments on temperature deviations
Tom Buggy, Auditor MSQ, DSM Corporate Operational Audit, The Netherlands

Data Integrity – How big the issue is?
How do the Inspectors assess sites/companies for data integrity either in a paper system and IT systems
Concerns and implications
Are Inspectors finding more area of concern or isIndustry reacting to the need to control data integrity?
What are the trends
Does industry fully understand data integrity
How far inspectors expect industry go to mitigate the (possible) data Integrity issues
What are the potential consequences of companies exposed to data integrity issues

Joint GMP and Regulatory Affairs Day
Parallel Sessions, Part A
Session 1:
Quality expectation of starting materials
HA expectations and recent observations
GMP’s for Starting materials (manufacturing / analytical)
Auditing of Starting materials
Francois Vandeweyer, Janssen Pharmaceutica, Belgium

Session 2:
GMP requirements on API facility design
What GMPs really required for facility design?
Which guidelines and standards can help?
Which basic design concepts you should follow
What are “state of the art“ solutions?
What are the most common design problems?
Ralf Gengenbach, gempex Co. Ltd., Germany

Session 3:
Regulatory Hurdles and Opportunities
Graca Mata, Hovione, Portugal
Victoria Waddington,
Regulatory Compliance,
Macfarlan Smith Limited A Johnson Matthey Company

Parallel Sessions, Part B
Session 4:
ICH Q3D – the role and responsibilities of API manufacturers
What is the responsibility of the API industry in supporting product license holders achieve compliance with ICH Q3D?
What are the expectations of our customers?
How/what is an acceptable risk assessment for APIs with regard to ICH Q3D? (With alternative approaches)
Experiences from the API industry – good and bad
Colin Rienewerf, Piramal, United Kingdom

Session 5:
GDUFA practical experiences
GDUFA overview
DMF Initial Completeness assessment
New Guidance under GDUFA
George Hartong van Lokven, Aspen Oss B.V., The Netherlands

Session 6:
Data integrity – Industry perspective
Key areas of concern
How to mitigate data integrity issues
Examples of measures taken
Experience with inspections
Roisin Hickey, Hovione, Ireland

ICH Q11 regulatory starting materials Q&A – does it help industry?
Overview of the ICH Q11 Q and A
Will we have a global harmonisation view on definition of a registered starting material
Impact of the Q and A to the API industry
Pros and cons of the Q and A document
Rudy Peeters, Janssen Pharmaceutica, Belgium

ICH Q12 – impact on Post Approval Changes
Current status
Concerns and implications
How it will impact the post approval changes
What type of changes will benefit
How much the industry will benefit from the guideline
Graham Cook, Pfizer, United Kingdom

Combined play of GMP and regulatory aspects in the regulatory dossier
What GMP requirements are currently part of the dossier?
How did the requirements evolve over time?
How does this impact the patient and industry?
Is the regulatory dossier the best place?
Hilde Vanneste, Janssen Pharmaceutica, Belgium
Update on current EDQM activities and initiatives
Hélène Bruguera, Deputy Head/Division Certification of Substances, EDQM

Regulatory Affairs Conference
After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of how API registration works in emerging countries followed by an overview about regulatory filing expectations and new Pharmacopoeia requirements in China. Presentations about the development of impurities specifications over the years and aspects of APIs changes assessment will round off the Regulatory Affairs Conference programme.

API registration in Emerging Markets : current industries’ experiences
How do API registrations work?
What are the challenges in the emerging countries?
The APIC Task Force outcomes
Lore Vignoli, Regulatory Affairs, Roquette Freres, France

China, Regulatory filing expectations and new Chinese Pharmacopoeia requirements

Development of Impurity specifications over the years
Guidelines: from the past to the future
The importance of technology innovation
Assessment by the Competent Authorities
Impact in the Pharmaceutical Industry
Jean-Louis Robert, Chairman of the EMA QWP, United Kingdom

Assessment of APIs Changes
Current situation
Generic API’s: a regulatory nightmare
Desired situation
Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V., The Netherlands


This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more

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E-Mail: info@gmp-compliance.org

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