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Blog & Article
- 9th July 2024
Die jüngste PDA Good Aseptic Manufacturing Conference, die am 15. und 16. Mai 2024 in Stuttgart stattfand, bot eine Plattform für Branchenführer, Regulierungsbehörden und…
Video
Quality Management and Compliance
Our Quality Management and Compliance (QMC) team is involved in all aspects of the Product Lifecycle from innovation to commercialisation providing strategic consultancy related…
Blog & Article
- 11th June 2024
One of the most widely discussed concepts within the revised Annex 1 is a contamination control strategy, or CCS[1]. The guidelines require the implementation…
Blog & Article
- 10th June 2024
The National Institute for Bioprocessing Research and Training (NIBRT) and Cencora PharmaLex collaborated on an event to discuss the EU GMP Annex 1 requirements…
Video
Annex 1 – Navigating the road to a successful inspection
Blog & Article
- 7th May 2024
Authentic management oversight and active engagement is an important determinant for an effective and robust CAPA process. Senior management support for a quality culture…
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