Richard M. Bonner, ECA, formerly with Eli Lilly, U.K
Dr Rainer Gnibl, GMP-Inspector for EMA and local Government, Germany
Dr Gerald Kindermann, F. Hoffmann-La Roche Ltd., Switzerland
Aidan Madden, FivePharma, Ireland
During this course, you will learn all relevant aspects to efficiently organise and improve your Complaint Handling and Recall System to fulfil current GMP requirements and to get the best benefit for your daily business.
In principle, every complaint might cause a recall, and every complaint may provide an opportunity to improve.
According to the EU-GMP Guide Chapter 8, the pharmaceutical industry must review all complaints and other information concerning potentially defective products carefully according to written procedures. In order to provide for all contingencies, a system should be designed to investigate the need to recall, if necessary, promptly and effectively products known or suspected to be adulterated from the market-place.
According to the EU- GMP Guide, a person should be designated responsible for handling the complaints and deciding the measures to be taken. The Qualified Person (QP) should be made aware of any complaint, and be actively involved in the investigation and any subsequent recall.
The handling of technical complaints (also called non-medical complaints) triggers high demands on the process organisation and quality system. However, these complaints are also a chance for continuous improvement and to prevent the reoccurrence of future failures.
This course is designed for all personnel involved in complaint handling and/ or recall activities at their company and all responsible persons like the Qualified Person and decision makers who want to improve the existing process.
Regulatory Requirements for Complaint Handling and Recalls - The Inspector’s View
Complaint Handling Session
The Handling of Complaints (Part 1)
- EU Legislation on Complaints, Recalls & Falsification
- Real Intension of Complaint Handling
- Definition and Classification of Quality Defects
- Rapid Alert System - RAS
- What a Complaint Handling SOP should consider
- What a Recall SOP should consider
The Handling of Complaints (Part 2)
- Implementation into the GMP System
- When do you need to involve the regulatory authorities?
- Interface to Pharmacovigilance, and the role of the QPs
- Incoming complaints, who receives them, who investigates and who approves communications and responses?
- Sample handling and storage
- What is a 3 day field alert (FDA requirement) and is this important in the EU?
- Initial documentation
- Software/ databases
- Sample evaluation
- Failure Investigation
- Why complaints can be good !!
Effective Root Cause Analysis and Failure Investigation
Quality Risk Management Session
The Basics of Quality Risk Management
Implementation of a Quality Risk Management
- Definitions and abbreviations
- Regulatory requirements and expectations
- Areas of application
- Construction of a QRM matrix
Workshop on Case Studies:
- System in Complaint Handling
- How to use real data from global issues to determine process understanding and customer satisfaction and to set priorities.
Quality Risk Management in Complaint Handling and Recall Procedures
The Handling of Recalls
How to perform a Mock-Recall
- Implementation in the system
- The recall process
- Flow of information
Both FDA and EU-GMPs call for regular evaluations of the effectiveness of the recall processes. This session will show you, how such an effectiveness check could be performed.
When to recall or not to recall – that’s the question
The participants will work through a single hypothetical scenario. Working in small groups the participants will need to decide what action to take, what information is needed, who should be involved, and ultimately decide if a recall is required and if so to what level.