Programme

GMP & GDP PART - 23 June 2021

Moderated by: Dr Urich Kissel

Brexit: Consequences for GMP and GDP Environment

• What is the impact of Brexit on Pharma Regulations?
• New GMP and GDP expectations from UK 
• How Pharma Industry in EU should manage the UK business
• What impact all this has on the patients

Dr Afshin Hosseiny, Chairman ECA Foundation and European GDP Association 

EU GMP Annex 21: Import of Medicinal Products 

• The meaning of importation within scope of Annex 21 
• What is new in Annex 21 (draft)? 
• What do we miss in Annex 21 (draft)?
• Conclusions and comments on the document

Dr Ulrich Kissel, Chairman European QP Association

PARALLEL SESSIONS & WORKSHOPS WITH INSPECTORS

Moderatored by: Dr Afshin Hosseiny / Dr Ulrich Kissel, Gert Moelgaard / Dr Rainer Gnibl, Dr Wolfgang Schumacher / Ib Alstrup, Dr Christopher Burgess / N.N., Saddam Huq / Prabjeet Dulai

Get involved in the ECA Interest and Working Groups. Each delegate will be invited to discuss the upcoming developments with the Chairs/members of the groups and EU inspectors.

Agenda

You can address topics of interest and you can provide feedback on the currently planned activities. It is the aim of the Interest and Working Groups to provide a platform for discussion with both colleagues from industry and regulatory authorities.

Parallel-Sessions

Option 1 (Validation Group): Qualification & Validation: Supplier integration – how does this fit with GMP?

This interactive session will offer the opportunity for the participants to discuss some of new developments in qualification and validation activities:

• How can qualification and GEP interact?
• How can suppliers be integrated?
• Categorisation of equipment – a tool for streamlining qualification efforts
• Electronic qualification documentation

Option 2 (Quality Control Group): QC: How sure are you that your Laboratory Instrument/System is fit for its intended Purpose?

1. Introduction to the ECA AQC Group Guideline on Analytical Instruments and Systems Qualification Lifecycle
2. Overview of USP General Chapter and revision of spectroscopic General Chapters USP and and their relationship to the newly proposed analytical procedure lifecycle in USP
3. Reference standards for calibration and establishment of acceptance criteria for ‘fitness for purpose’

Option 3 (Data Integrity & IT Compliance Group): Data Integrity: Data Integrity in the GMP area

This interactive session will off er the opportunity for the participants to discuss current Data Integrity issues

• How to prepare for a Data Integrity inspection – the industry view
• Data Integrity Risk Assessment
• Data Integrity Inspection findings

Option 4 (GDP Group): How to Identify and Manage Falsified Medicines in the Supply Chain

This workshop will off er the opportunity to discuss the following aspects:

• What is a suspected falsified medicine?
• How to identify falsified medicine in your workplace?
• How to approach the investigation of a suspected pack?
• What should the end user do with the pack?
• Routine monitoring of incoming goods
• Who should manage communication with the end users?

Option 5 (GDP Group): Risk Management in GDP Warehouse

The risk-based approach is a fundamental requirement for processes in the GDP environment. Risk management is one of the mandatory basic elements. It is applicable to a variety of activities and processes. This workshop will cover challenges and possible solutions concerning risk management in GDP warehouses. Different examples will be discussed.

SESSION Inspections/Audits in Covid-19 Times

The corona pandemic causes unusual supplier qualification activities. Meetings face-to-face are reduced or not possible at all. This concerns supplier audits but also regulatory inspections. To fulfil GMP-requirements and to prevent travelling and meeting people personally is a balancing act. How to react?

Distant Assessments – GMP-inspector´s view

• Regulatory basis
• Requirements from guidelines
• Examples from inspections 
• Reliability in “real life”

Dr Rainer Gnibl, GMP Inspector