Programme of the 7th GMP Conference
Introduction – Update ECA
Richard Bonner, Chairman ECA
Session I Current Initiatives in EU and FDA
Moderator: Richard Bonner
This session will discuss the latest changes and current initiatives in EU GMP and FDA GMP Regulation
Update from recent EU GMP changes
- Latest Changes in EU Regulations
- Latest Revisions of the EU GMP Guide and its Annexes
- New EMA Guidelines with impact to GMPs
- Look over the pond - Important GMP developments in the US
Dr Bernd Renger, QP and immediate past chair of the EQPA
The new EU/US Mutual Recognition Agreement
- Details of the new agreement
- Consequences for EU and FDA Inspections
- Transitory Provisions
Maria-Jesus Alcaraz, EMA UK
Doing business with companies that operate outside of the EU/FDA zones
- 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?
Richard Bonner, Chairman ECA
Session II Data Integrity of GMP Data
Moderator: Dr Wolfgang Schumacher
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.
MHRA's view about Data Integrity, Typical problem areas and findings, MHRA Guidance document on Data Integrity
- Data Integrity Governance
- Are we seeing changes in the perception of Data Integrity?
- The good, the bad, the ugly and the shining stars
- Guidance and where next?
Tracy Moore, GMP Inspectorate
Implementation of a company wide data integrity program
- Elements to be covered
- How to identify GAPs in QC Labs and Production
- Communication and Training of employees
Amelia Mutere, F. Hoffmann-La Roche
ECA’s Data Integrity Guideline
- Overview of Data Integrity Interest Group
- Generation process of this guidance document
- Structure and Content
- Current status and next steps
Dr Wolfgang Schumacher, Head ECA’s IT Group
Session III Quality Oversight
Moderator: Dr Afshin Hosseiny
Recent FDA Warning Letters often mention ‘lack of Quality Oversight’. What is the European perspective on this subject? Could the FDA requirement on ‘Quality Metrics’ also be used as indicator for quality oversight? These questions will be discussed in this session.
Update on FDA's new Quality Metrics Guideline
- Explore the specific details that are new and different in the revised draft guidance, including metrics, definitions and reporting strategies.
- Overview of the FDA’s plans for compiling and analyzing the metrics data from pharmaceutical companies.
- Summary of short and long-term plans for quality metrics.
Alex Viehmann, FDA
Measuring and Monitoring of Quality Assurance: Regulatory Expectations
- Legal requirements – EU and international
- Links to ICH Q8, Q9 and Q 10 - Quality oversight
- Authority requirements
Dr Franz Schönfeld, GMP Inspectorate
Quality Oversight – how to make it successful?
- Building Quality Culture
- Use of existing Systems
- Benefits from using KPI Implementation in a pharmaceutical Company
- Regulatory expectations
- Case Study
Dr Andreas König, Quality König GmbH
Session IV Statistical/reduced Sampling
Moderator: Lance Smallshaw
Recent developments in GMP have focussed on statistics which involves taking large samples to assist with understanding of the processes. On the other hand Pharma industry is keen to reduce the number of samples due to costs. An EU inspector will give an overview on (statistical) GMP sampling requirements where an Industry representative will provide practical solutions for reduced sampling. .
Sampling – View of an EU GMP Inspector
- 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
Dr Matthias Heuermann, gmp inspectorate
Sampling strategies for raw materials and packaging materials in pharmaceutical industry
- Sampling plans
- How to define sample size for
- Primary Packaging Material
- Secondary Packaging Material
- When can sampling be reduced?
- How to deal with deviations?
Oliver Küttner, Shire
Session V Interest Group Meetings – Be involved in the next steps
Dr Afshin Hosseiny/ Johanna Linnolahti
Gert Mølgaard/Klaus Eichmüller
Dr Christopher Burgess/ Dr Matthias Heuermann
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.
Good Distribution Practice – Implementation Challenges
Moderator: Dr Afshin Hosseiny, / Johanna Linnolahti
This interactive session will offer opportunity for the participants to discuss some of the key challenges they face for implementation of the EU GDP requirements, for example:
- What is expected for product segregation in a warehouse – is electronic segregation sufficient? If so what are the expectations?
- What level of computer validation is appropriate for the wholesalers?
- How to qualify distribution of the medicines, whilst demonstrating compliance?
- Is maintaining product label claim conditions during transportation necessary? What evidence is expected from the regulators to demonstrate compliance?
- What level of training and education required for the RPs, if an RP is not a pharmacists, does he/she need to have additional training? Why?
Next generation Qualification and Validation – Implementation the new EU GMP Annex 15
Moderators: Gert Mølgaard, Klaus Eichmüller
This interactive session will offer opportunity for the participants to discuss some of the key challenges and opportunities for implementation of the new EU GMP Annex 15, for example:
- What is expected for qualification documentation from FAT, SAT, IQ, OQ, PQ etc.?
- What documentation can involve equipment suppliers, engineering services etc. in the future?
- How do you link the qualification documentation with the Process Validation?
- How do you establish a solid program for Ongoing Process Verification?
- What is the impact for the future of Product Quality Review?
Are you in control? Trend analysis as part of the Quality Management System
Moderators: Dr Matthias Heuermann, Dr Christopher Burgess
This interactive session will offer participants to discuss some of the key compliance challenges from both a regulatory and technical perspective in a workshop following two presentations by a GMP inspector and the chairman of the ECA Analytical Quality Control Interest Group.
- Presentation; The importance of trend analysis in a QMS and what a regulatory inspector looks for
Dr Matthias Heuermann LZG.NRW, Germany
- Presentation; Practical approaches to and tools for trend analysis; an overview of the new ECA AQCWG OOT &OOE guideline [Copy provided]
Dr Chris Burgess Chairman ECA AQCIG
- This facilitated ‚How much to we need to do‘ workshop session will allow participants to share and discuss their approaches and issues with Product Quality Reviews particularly with regard to what to trend and how to trend it