Pharmaceutical Packaging Systems - Part 1: Development & Part 2: Quality Control - Live Online Training
26-28 November 2024
Seminar-Nr. 21322
Referent:innen
Katharina Golly
Novartis
Torsten Kneuss
Bayer
Dr. Katrin Buss (invited)
Quality Assessor
Dr. Claudia Heinl
SCHOTT
Dr Gerald Kindermann
GxP Consulting
Dieter Mößner
Verpackungsexperte
Note: All times mentioned are CET.
Zielsetzung
The focus of these 2 GMP Education Courses is on the development and routine control of pharmaceutical packaging systems.
In Course 1 participants will learn how to develop pharmaceutical packaging materials systematically, and how to translate the requirements of the Common Technical Document (CTD) to regulatory documents for packaging materials. Topics to be addressed include compendial standards, container closure integrity, and combination products.
Course 2 will focus on the testing of a variety of different packaging materials, as carried out in every incoming-goods laboratory in quality control. This includes the setting of sound and scientific specifications and Acceptable Quality Levels (AQLs), the control of dimensions, and the control of primary and secondary packaging materials.
Hintergrund
There are a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc. Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.
The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products and sterile packaging materials (Annex 1 of the EU GMP Guide). To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, but also current challenges such as package integrity, glass delamination and particles on ready-to-sterilize (RTS) and ready-to-use (RTU) components.
Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed on, in conformity with the specifications and in compliance with the regulatory requirements.
In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, Defect Evaluation Lists have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing & sampling at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.
Zielgruppe
These GMP Education Courses are designed for employees working in pharmaceutical research and development, regulatory affairs, quality control, incoming goods control of packaging materials, and quality assurance departments. They are also directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical industry.
Technical Requirements
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Packaging Related Topics of the Common Technical Document (CTD)
CTD structure (packaging related)
Quality of components and materials
Declaration of compliance
Information to be provided in the dossier
Specific Aspects for Glass Materials
Why glass for pharmaceutical packaging?
The science behind glass
A glimpse into glass production
Outlook: Is there a chance for a sustainable glass production?
Q&A Session 1
Specific Aspects for Plastic Materials Vials and PFS made of Polymer
Extractable Elements
Sterilization Aspects
Critical Parameters
How to provide data to Regulators
Examples
Specific Aspects for Elastomeric Materials
Material background
Compendial compliance
Formulations and extractable elements
Sterilization
Critical Parameters
Extractables & Leachables
E&L Regulatory Landscape
Potential sources of Leachables
E&L Best practices
Case study(-ies)
Q&A Session 2
Day 2 - 27 November 2024
Regulatory Expectations on Drug / Device Combinations
Medicinal products vs. medical devices
Legal requirements and scientific guidelines
Medicinal products with medical device part
Development of Drug/Device Combination Products
Regulatory Background
Design Control
Usability
Risk management
Container Closure Integrity (CCI)
Definition (Leakage)
Test methods
USP <1207>
Challenges & Solutions
Q&A Session 3
Part 2: Pharmaceutical Packaging Systems - Quality Control
Day 1 - 27 November 2024
Defect Evaluation Lists
Principles for the Defect Evaluation Lists (DELs)
Application of AQLs (Acceptable Quality Levels)
Examples for Containers made of moulded and tubular glass
Control of Printed Packaging Materials
Defect Evaluation Lists for Secondary Packaging Materials
Printing, Coding & Artwork
Serialization & Tamper Evidence
Defect classes and (100%) test procedures (Examples)
Technical Specifications
Scope & content
Concept (proposal)
Defect classes and selected test procedures (Example)
Shelf-life of Packaging Components
Why is a defined shelf-life required?
How to define the shelf-life for packaging components?
Re-Testing of packaging components
Q&A Session 1
Day 2 - 28 November 2024
Qualification of Analytical Instruments used for Packaging Control
Important points for qualification (IQ/OQ/PQ)
Software validation
Examples (e.g. tensile testing)
Control of Primary Packaging Materials - Examples for Pouches and Blisters
Overview of the development / production of pouches / blisters
Control of process parameters / products during production (IPC)
Control of final products
Supplier Management
Applicable GMP standards for packaging suppliers
Selection of suppliers
Technical agreements, supplier qualification and audits
Continuous supplier evaluation
Q&A Session 2
Risk Based Inspections of Packaging Materials
How to set up a control system for packaging materials
Practical application of FMEA
What, why, and how to test
Strategies for reduced testing
Case Study on Reduced Testing / Reduced Sampling
Inspection Procedures for Primary and Secondary Packaging Materials
Q&A Session 3
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Abweichungen und CAPA (QS 12) November 2024
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