The webinar will look at the challenges of implementing a GMP compliant Quality Management System for chromatography products. Although the chromatography products manufactured by Astrea Bioseparations are not regulated we understand that our products are critical to our client and have the potential to impact the Quality of the plasma-derived therapeutics. In the Webinar Colin Grant, Director of Quality & Regulatory Affairs, will go through our continuous process improvements from the implementation of clean rooms to developing our Quality Management System in line with GMP for API guidelines according to Rules and Guidance for Pharmaceutical Manufacturers and Distributors. This webinar is a beginning of a set of training programs where we will break into greater detail how we implemented processes that support our QMS including Risk assessments, Root Cause analysis and Implementing an Electronic Quality Management System.
Section 2 provides a brief overview of the EvolveD column.
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Section 1 contains Astrea Bioseparations Ltd Quality Policy & Accreditation
Section 8 contains a technical user guide and packaging information.
The regulatory support file for EvolveD columns contains all relevant support information to use the columns for GMP production purposes.
Section 9 contains version control and document approval.
Section 7 contains information related to stability and shelf life of the packed columns. This includes an efficiency study, mechanical stability study (of the empty column) and a sanitisation study.
Section 4 contains analytical information and methods used.
Section 6 contains safety information including shipping studies to demonstrate the column packing robustness.