Dr Bettine Boltres
West Pharmaceutical Services
Referent:innen
Torsten Kneuss
Bayer
Note: All times mentioned are CET.
Zielsetzung
In this live online course, you will learn which requirements apply to primary glass packaging materials. You will get to know all aspects of the GMP manufacture of glass products (e.g., vials, bottles, syringes) that influence the quality of the final product. In addition, practice-oriented presentations and case studies will guide you through the relevant requirements for manufacture, controls and release of glass containers, including impact of the new EU GMP Annex 1 (e.g., for ready-to-use, ready-to-sterilize material).
Hintergrund
Glass materials used in pharmaceutical packaging systems must be suitable for the intended use. To address these issues, the pharmacopoeias (e.g., USP / Ph. Eur.) contain dedicated glass chapters providing specifications and quality requirements.
Following a recent FDA request to update the Type I definition from one that is composition-based to one that is performancebased (e.g. hydrolytic resistance), the USP is currently revising its general chapter <660> Containers – Glass. The request highlighted the FDA’s concern about global issues regarding glass production and resulting drug shortages.
Glass is not fully inert. Therefore, in addition to the glass Surface tests, Extractables & Leachables have to be considered.
Furthermore, in the last number of years, delamination and visible foreign particulate matter (i.e. glass particles), became the number one reason for glass related recalls in the Pharmaceutical industry. Therefore, the attention and demands of the authorities has increased, with a special focus on root cause Investigation of the particle contamination. Compendial chapters have been changed and specified accordingly.
In addition, new GMP requirements for the sterile packaging material apply with the revised EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”, which provides guidance on the approaches to sterilization of products, equipment and packaging components.
Zielgruppe
This online event is designed for employees working in the Pharmaceutical industry (including drug device combination products), for suppliers of packaging materials & devices and to all who have to deal with the manufacture, control and release of primary glass packaging materials.
Technical Requirements
We use Webex for our live online training courses and webinars. At 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
Fundamentals of Tubing and Container Production
- Basics of how tubular glass containers are produced
- Fundamental Knowledge
- Challenges occurring with tubular glass containers
Fundamentals of Molded Glass Production
- Basics of how molded glass containers are produced
- Fundamental Knowledge
- Challenges occurring with molded glass containers
Sterile Glass Containers & EU GMP Annex I Requirements
- Annex I and Sterile primary packaging components
- Packaging suppliers are expected to follow the Basic Annex I requirements
- How sterile glass container manufacturers are addressing the respective applicable topics to help customers becoming or staying compliant with EU GMP Annex I
Q&A Session 1
USP Update – What May Change
- USP General Chapter <660> Containers - Glass
- USP General Information Chapter <1660> Evaluation of the Inner Surface Durability of Glass Containers
- Upcoming major revision to the 2 glass chapters to allow the addition of both modern analytical technologies and additional glass formulations now being used to produce pharmaceutical glass containers
- Discussion of the progress made in updating the analytical methods that are used to ensure the quality of glass containers, and how new glass formulations could be added to the USP‘s glass chapters
Extractables & Leachables / Delamination
- Brief review of mechanisms by which drug products interact with glass containers
- Implications of extractables & leachables for the safety and efficacy of parenteral drug products
- Brief review of glass delamination and a discussion of factors that can impact the propensity for delamination
Requirements for Glass Containers used in Combination Products
- Introduction to Combination Products
- Regulatory Requirements for Combination Products
- Applicable Standards and Regulations for Glass Containers (e.g. syringes)
- Requirements related to manufacturers of Glass Containers
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