Pharmaceutical Packaging Systems - Part 1 - Development - Live Online Training
29/30 November 2022
Seminar-Nr. 20122
Referent:innen
Dr. Katrin Buss
Quality Assessor
Torsten Kneuss
Bayer
Dr Bettine Boltres
West Pharmaceutical Services
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
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.
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
Ph. Eur. / USP
Extractable Elements
Sterilization
Critical Parameters
Q&A Session 1
Specific Aspects for Plastic Materials
Ph. Eur. / USP
Extractable Elements
Sterilization
Critical Parameters
Specific Aspects for Elastomeric Materials
Material background
Compendial compliance
Formulations and extractable elements
Sterilization
Critical Parameters
Extractables & Leachables
Regulatory background
Principles of extractable and leachable testing
Potential extractables & leachables
Case Studies
Q&A Session 2
Day 2 - 30 November 2022
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
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Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023