Programme of the 8th GMP Conference
Introduction – Update ECA
Dr Afshin Hosseiny, Chairman ECA
Session I - Current Initiatives worldwide
Moderator: Lance Smallshaw
This session will discuss the latest changes and current initiatives in EU GMP and FDA GMP regulations. In addition, the Mutual Recognition Agreement between the EU and US (FDA) will be discussed.
GMP Update 2019 and Outlook 2020 – current Trends and Developments in Europe, US
- Major GMP developments and their impact for pharmaceutical industry
- The revised EU & PIC/S GMP Annex 1 – implications and experiences
- The new EU GMP Annex 21 on Importation and its implication
- Additional GMP developments from EMA and FDA
- Brexit and its consequenses for the European GMPs
Dr Bernd Renger, QP And Immediate Past Chair of the EQPA
The Mutual Reliance Initiative on EU-FDA Inspections: Current Status and next Steps
- Details of the agreement
- Consequences for EU and FDA Inspections
- Transitory Provisions
- Schedule and Procedure for the next steps
TBD Regulatory Authority
Brexit and increasing Drug Shortages: What does this mean for QA in Practice?
- European Pharm Industry post Brexit
- Impact on the product supply across Europe
- GMP compliance – are we compromising quality now that UK is a 3rd country?
- Long term impact on patient safety costs and supply
Dr Afshin Hosseiny, Chairman ECA
Session II - New and revised ECA Good Practice Guides - What QA needs to know and helpful tools
Moderator: Dr Afshin Hosseiny
GMP requirements often lack concrete recommendations for implementation. Therefore ECA´s working and interest groups have been set up to develop so called Good Practice Guides. In this session you will get an update on the content of these Guides. Data Integrity has been the major GMP compliance issue in the past two years. Today, companies need to make sure that all sites, suppliers and contract labs comply with the regulatory requirements. This interactive session will discuss pragmatic approaches how this can be achieved. With the revision of FDA´s Process Validation Guidance and the Annex 15 a process validation life cycle became state of the art. Especially in the FDA guidance qualification and process validation are close together. How can this be achieved? This will be discussed, also referring to ECA´s Good Practice Guide on Modern Qualification. The ICH Q2 (R1) document about Analytical Method Validation will be revised. Why and the direction of the changes will be discussed. And how ECA´s Good Distribution Guide can be used for implementation and inspection will be presented too.
Data Integrity: How to manage oversight over suppliers, service providers, contract manufacturers and mutiple sites
- Data Integrity implementation – Status of the industry 2019
- ECA Data Integrity Guide version 2.0
- ECA´s new Data Integrity Toolbox
- How to ensure compliance with Data Integrity requirements
Dr Wolfgang Schumacher, Chairman, ECA It Compliance Group
Integrating Qualification and Validation from a QA Perspective - introduction into ECA's Modern Qualification Guide
- What does "Modern Qualification" mean?
- ECA´s Modern Qualification Guide – and the link to Modern Process Validation
- Fast track facility projects using a modern qualification approach
- Teaming up with suppliers and other partners
- Subject matter experts and the modern role of QA in the future…?
Gert Moelgaard, Chairman, ECA Validation Group
What QA Needs to know about changes to ICH Q2(R1), Analytical Method Validation, and the proposed ICH Q14 on Analytical Procedure Development
- Reasons for the need to revise ICH Q2(R1) – Why the change from Method to Procedure?
- New lifecycle approach to the Validation for Analytical Procedures based on the FDA Process Validation model, 2011
- USP General Chapter <1220>, Analytical Procedure Lifecycle, 2017
- The ECA AQCG Guide to Analytical Procedure Lifecycle Management (APLM), 2018
- The aims & objectives of ICH Q14, Analytical Procedure Development using analytical quality by design methodology (AQbD)
Dr Christopher Burgess, Chairman ECA Analytical Quality Control Group
What QA Needs to Know About Good Distribution Practice compliance trends: The ECA/PQG Guide on Good Distribution Practice
- What is state of the art regarding GDP?
- What is the state of play regarding GDP implementation in industry
- Frequent findings during GDP inspections and audit
- The final version of the ECA and PQG Guide on the interpretation of GDP
- How to use the Guide for GDP implementation and GDP inspection
Dr Afshin Hosseiny, Chairman of the ECA Foundation and Head of ECA GDP Association
Session III - GMP Inspectors meet Industry - Urgent Non-Compliance Issues
Moderator: Dr Ulrich Kissel
Recent FDA Warning Letters and GMP Non-compliance Reports in EMA´s EudraGMDP database show a great number of GMP findings. But what are most frequently observed GMP deviations at EU inspections? In this session you will learn from an inspector about recent inspection experience. An industry speaker will describe how companies with multiple manufacturing sites can prepare for successful GMP inspections.
Inspectors View: Non-compliance-issues – Is it all only about Data Integrity!?
- Which areas are critical to trigger Non-Compliance Statement
- What is critical with these areas?
- Inpropper Data-Management
- Deficiency examples from GMP inspections
Dr Rainer Gnibl, GMP Inspectorate
Industry view: How to Make Sure That all Sites and Suppliers are in Compliance
- Does industry make best use of the concepts laid down in the GMP rules?
- The supply chain diagramm
- The Technical (Quality) Agreement
- The product specification file
- The QP declaration
- Auditing by yourself or a third party
- Product Quality Review
Dr Ulrich Kissel Director Regulatory Affairs, ECA and Chairman, European QP Association
Session IV - Parallel Sessions & Workshops with Inspectors
Dr Afshin Hosseiny/ TBD
Gert Moelgaard/Dr Rainer Gnibl
Dr Wolfgang Schumacher/ Ib Alstrup
Get involved in the ECA Interest and Working Groups. Each delegate will be invited to discuss the upcoming developments with the Chairs of the Groups and an EU Inspector.
You can address topics of interest and you can provide feedback on the currently planned activities. It is the aim of the Group to provide a platform for discussion with both colleagues from industry and regulatory authors.
Option 1: Qualification & Validation: How to save time and money in Qualification & Validation but comply with GMP
This interactive session will offer opportunity for the participants to discuss some of new developments in qualification and validation activities:
- How can qualification and GMP interact?
- Integration of qualification into Validation
Option 2: Data Integrity: How to manage oversight over suppliers, contract manufacturers and multiple sites
Data Integrity as been the major GMP compliance issue in the past two years. Today companies need to make sure that all sites and suppliers comply with the regulatory requirements. This interactive session will discuss how this can be achieved.
Option 3: GDP: How to manage the interface between GMP and GDP
Complex supply chains require that the interface between GMP and GDP work correctly. Manufacturing and distribution of medicinal products need to comply with the regulatory requirements. Learn more about this important Interface.