Avoiding non-Compliance in Packaging Operations - Live Online
8/9 March 2022
Course No. 19039
Speakers
Dr. Franz Schönfeld
Regierung von Oberfranken
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
David Abraham
QRS-Associates
Note: All times mentioned are CET.
Objectives
This GMP Live Online Training Course aims at easily explaining the GMP requirements for packaging of medicinal products.
This includes requirements for premises and equipment but also for QA operations like documentation, line clearance, validation etc.
Background
Packaging of medicinal products, blistering as well as cartoning for example, plays a crucial role in the quality and safety of a medicine. Deficiencies of primary packaging may alter the efficacy or stability of a product; failures in secondary packaging may do harm to patients even worse when products or the folding boxes are mixed up. Therefore, packaging is defined as (the last) pharmaceutical manufacturing step and one of the most critical ones. It is not surprising that the biggest part of recalls is caused by failures during packaging. The FDA reported that more than 30% of recalls of tablet products during the last 5 years were caused by label mix-ups, incorrect packaging or incorrect products insert. On the other hand, despite the high criticality of the packaging process, the packaging plants are required to cut the costs and raise their Efficiency.
Another challenge for the packaging units is the new EU Directive, requiring safety features and authentication measures in order to raise the hurdle for drug counterfeiters. As a consequence of the “COMMISSION DELEGATED REGULATION (EU) 2016/161”, the rules apply from 9th of February 2019 onwards except for some member states with an existing Verification System. Packaging lines have to be equipped with systems for printing and reading two dimensional codes (2D-Codes) and these systems have to be linked to the materials management system. Companies already shipping serialized products have been reporting from technical hurdles which should not be underestimated. Most companies without experience in this field will need external help. But technical expertise could become rare in the near future.
There are numerous requirements which have to be fulfilled in the packaging plant. During this GMP Live Online Training we will focus on:
Compliance & QA requirements
QA Systems
Hygiene and Cleaning
Qualification / Validation
Technological aspects
Facility and Zone Concepts
Design of packaging equipment
Packaging materials
Handling, storage and mix-ups
Suppliers
Special topics:
Serialisation & Authentication
Highly Potent Products
Target Group
Staff from QA and production engaged in packaging operations is the target group of this course as well as suppliers for equipment and packaging material used for packaging of medicinal products.
Technical Requirements
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Note: Provisional timetable, the actual schedule may vary depending on the situation.
Programme Day 1
09.00 - 09.15 h Welcome & Introduction
09.15 - 10.15 h
GMPs and QA Oversight for Packaging Operations
GMP requirements in the packaging unit
Important Guidelines and standards
QA Systems relevant for packaging operations
Frequent inspection findings
10.15 - 10.20 h Short Break
10.20 - 11.30 h
General GMP requirements for Packaging Operations / Key Compliance Challenges for Packaging Operations
Handling and storage of packaging materials
Testing
Stability issues
Material storage, returned goods, quarantine
Line Clearance
Documentation practice
Practical GMP aspects
Good and bad practice
11.30 - 11.45 h Break
11.45 - 12.30 h
Quality and Compliance systems in the Packaging Plant
Hygiene and Zone Concepts
Material flow
Line clearance procedure
IPCs in the packaging process
Documentation and control
Handling of variable printing data
12.30 - 13.00 h Q&A Session 1
13.00 - 14.00 h Break
14.00 - 15.00 h
Packaging of Highly Potent Products / Q&A Dynamic Session on Packaging (Tips & Problems)
Cross Contamination – how to avoid it:
1 – dedicated vs multi product facility
2 – production planning
3 – cleaning procedures
4 – people movement
15.30 - 15.30 h Secondary Packaging (Interactive Session)
15.30 - 15.45 h Break
15.45 - 16.30 h
The Application of GxP in Packaging Supply
Relevant ISO standards
Introduction to British “GMP for Packaging Materials”: PS 9000:2016
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
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