Katharina Golly
Novartis
Referent:innen
Torsten Kneuss
Bayer
Dr. Katrin Buss
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.
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.
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
We use Webex Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online- training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Part 1: Pharmaceutical Packaging Systems - Development
Day 1 - 26 November 2024
Regulatory Framework applicable to Pharmaceutical Packaging Materials
- Code of Federal Regulations (CFR)
- US Guidance for Industry: Container Closure Systems
- EC Guidance: Plastic Immediate Packaging Materials
- Compendial Standards (USP, Ph. Eur., JP)
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
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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This course is part of the GMP Certification Programme "ECA Certified Packaging Manager"
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