Richard Bonner, Qualified Person and Chairman ECA, UK
Dr Christopher Burgess, Qualified Person and Chairman of ECA‘s Quality Control Working Group, UK
Klaus Eichmüller, Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Dr Matthias Heuermann, NRW Centre for Health (LZG.NRW), Münster, Germany
Dr Afshin Hosseiny, Qualified Person and Chairman of ECA‘s GDP
Interest Group, UK
Dr Andreas König, Quality König GmbH, Germany
Oliver Küttner, Shire, Austria
JOHANNA LINNOLAHTI, Finnish Medicines Agency FIMEA, Finland
Gert Mølgaard, Chair of ECA‘s Working Group on Validation, Denmark
Tracy Moore, Medicines and Healthcare Products Regulatory Agency, UK
Dr Bernd Renger, Qualified Person and Immediate Past Chair of the EQPA, Germany
Dr Franz Schönfeld, GMP Inspectorate, Germany
Dr Wolfgang Schumacher, Chairman ECA´s IT Compliance Group, Switzerland
Lance Smallshaw, ECA Executive Board Member, Belgium
The EU GMP Conference is only offered every two years. This unique conference will discuss current and planned changes to the GMP regulation. All experts and managers involved in GMP compliance activities will have the opportunity to get a comprehensive GMP update and to talk to the leading experts from industry and authority.
Although EU GMP is in the center of attention, a harmonized approach with cGMP from FDA will also be an important aspect of the agenda. For international operating companies both EU GMP and FDA compliance is important and the corporate quality systems need to cover the regulation of both regions.
The agenda will therefore focus on key GMP compliance developments. Attention will be paid on the implementation of these requirements into pharmaceutical quality systems. The ECA Foundation’s objective is to support industry, and therefore current activities as well as guidance documents and SOPs are presented during this conference.
Each Session will have speakers from industry and inspectorates to discuss both expectations and implementation aspects.
We wish you a successful and interesting conference.
Richard M. Bonner
Chairman of the ECA Advisory Board
The conference is of particular interest for GMP experts of pharmaceutical companies (e.g. QA, QC, production, distribution, regulatory affairs, validation), of GMP inspectorates and Regulatory Authorities.
ECA Guidance Document on Data Integrity
ECA Guidance Document on OOE and OOT
ECA Good Practice Guide on Validation Version 02
ECA/PQG Guide on Good Distribution Practice
Session I Current Initiatives in EU and FDA
This session will discuss the latest changes and current initiatives in EU GMP and FDA GMP regulation
Update from recent EU GMP changes
Mutual Reliance Initiative
Doing business with companies that operate outside of the EU/FDA zones
- Latest Changes in EU Regulations
- Latest Revisions of the EU GMP Guide and its Annexes
- New EM Guidelines with impact to GMPs
- Look over the Pond - Important GMP developments in the US
Session II Data Integrity of GMP Data
- How do I know if the company is producing using equivalent GMPs
- Do cultural differences matter?
- How will I know if anything goes wrong?
- What if I am purchasing through a broker?
- What is my QP responsible for?
Data Integrity is one of the top topics since some years. Data Integrity is not very detailed described in the EU GMP Guide. So some national authorities (e.g. MHRA) published interpretations about Data Integrity. Also the FDA has published a Guideline on it. The current status regarding Data Integrity is discussed in this session.
GMP Inspections and Data Integrity – Typical Pitfalls
How to train company staff in Data Integrity
- MHRA´s Data Integrity Guideline
- Authorities expectations
- Inspection findings
ECA’s Data Integrity Guideline
- Training as a QA Tool
- The special case: Data Integrity Training
- Case Study
Session III Quality Oversight
- Overview of Data Integrity Interest Group
- Generation process of this guidance document
- Structure and content
- Current status and next steps
In FDA Warning Letters the lack of Quality Oversight is often mentioned. How is this been seen from an European perspective? Could the FDA requirement on FDA Quality Metrics could also be used as indicator for quality oversight? These questions will be discussed in this session.
Measuring and Monitoring of Quality Assurance: Regulatory Expectations
Quality Oversight – how to make it successful?
- Legal requirements – EU and international
- Links to ICH Q8, Q9 and Q 10 - Quality oversight
- Authority requirements
Session IV Statistical/reduced Sampling
- Building Quality Culture
- Use of existing Systems
- Benefits from using KPI Implementation in a pharmaceutical company
- Regulatory expectations
- Case Study
In the movement of the GMPs in the last years one development could be seen. More focus on statistics. This concerns also sampling. On the other hand industry wants to reduce sampling as sampling is costly. An EU inspector will give an overview about (statistical) GMP sampling requirements and an Industry representative will give practical information regarding reduced sampling.
Sampling – View of an EU GMP Inspector
Sampling strategies for raw materials and packaging materials in pharmaceutical
- API and finished goods sampling und testing
- EU GMP Guide sampling requirements
- Part 1, Chapters 4, 5, 6
- Part 2, Chapter 7
- Other regulations
- US / FDA Requirements
- Supplier qualification and audits
- Reduced testing
- Statistical sampling
Session V Interest Group Meetings – Be involved in the next steps
- How to define sample size for APIs
- Primary Packaging Material
- Secondary Packaging Material
- When can sampling be reduced?
- How to deal with deviations?
Get involved in the ECA Working Groups. Each delegate will be invited to discuss the upcoming developments with the Chair/Co-Chairs of the working groups.
You can address topics of interest for you and you can provide feedback on the currently planned activities. It is the aim of the Working Group to provide a platform of discussion with both colleagues from industry and regulatory authorities.