- Requirements for compliant change management
- Authority's expectations for GMP compliance
- AMG, AMWHV, EU regulations, ICH Q8, Q9, Q10, Q11, Q12
- gempex expertise in a Concept-Heidelberg seminar
- May 15 and 16, 2024, Mannheim
Changes in manufacturing and review of Active Pharmaceutical Ingredients and Finished Products have to take GMP compliance into account. The establishment of a change management system is required. Clean planning and intelligent risk assessment of changes are prerequisites for controlled and efficient implementation ensuring compliance with the regulations.
For manufacturer and market authorisation holder involved in the manufacture of Active Pharmaceutical Ingredients and Finished Products, it is fundamentally important to create the conditions to ensure risk-controlled planning and implementation of changes as changes are subject to the GMP requirements. The GMP Guidelines, the ordinance on the manufacturing of Active Pharmaceutical Ingredients and Finished Products (AMWHV, Germany) and EU regulation 1234/2008 form the basic legal framework here.
Forward-looking planning in design and manufacturing as well as an appropriate analytical control strategy are valuable if changes are to be implemented easily and compliantly later on.
All this is topic of the seminar "Change Control - from planning to implementation of changes", which Concept-Heidelberg is organizing in Mannheim on 15 and 16 May as part of the "Quality Assurance" course. All important aspects of change management will be provided.
gempex supports the event with expertise from practice, authorities, and sound regulatory knowledge. Dr. Martin Melzer, Principal Consultant at gempex GmbH, will speak on the topics of "Definition and categorization of changes relevant to licensing", "planning changes that have an impact on licensing" and "Life Cycle Management".
Examples from everyday project work illustrate the complex topic. In the workshop, participants from production, technology, quality assurance, quality control, IT, licensing and project management can consolidate what they have learned with a view to product and process.
If you have any questions on the topics of change control for Active Pharmaceutical Ingredients and Finished Products, risk management or control strategy, please contact Dr. Martin Melzer via contact@gempex.com.
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