Dr Bettine Boltres, West Pharmaceutical Services, Germany
Dr Michael Eakins, Eakins & Associates, USA
Dr Matthew Hall, Corning, USA
Torsten Kneuss, Bayer, Germany
Kevin McLean, SGD, USA
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).
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.
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.