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).
Background
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.
Target Group
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
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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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Testimonials
Seminar Programme as PDF