How InstantGMP PRO Workflows Expedite Qualified Person Activities for the European Union Regulations

One key requirement of the European Union regulatory guidelines is that Electronic Batch Records be certified by a Qualified Person. The Qualified Person also has other responsibilities outlined below, as detailed in Annex 16 of the EU Guidelines for GMP and defined by the European Medicines Agency (EMA).

The Qualified Person is an EU authority, described as a person who:  

1. Has extensive education and training in regulatory affairs, etc., meeting the specific qualifications outlined in:
   1. EU Directive 2001/82/EC -Marketed Veterinary Medicinal Products
   2. EU Directive 2001/83/EC– Marketed Human Medicinal Products
   3. EU Directive 2001/20/EC– Investigational Medicinal Products
2. Has primary responsibility for certifying batches of regulated products. 
3. Has responsibility for validating manufacturing, testing, and storage processes to ensure compliance.
4. Maintains detailed records of batch certifications and investigation and appropriate actions for deviations.
5. Oversees the assessment and approval of suppliers and vendors based on quality and compliance.

At InstantGMP, our systems were built for automating and managing regulatory documentation. One clear example of how this can work in the EU is the deviation alert and batch certification process. We’ve designed it so that the Qualified Person can access and execute these events as part of the Electronic Batch Records workflow.   If the QP is external to the producing company, InstantGMP PRO assigns the QP secure use of these operations without requiring the purchase of an additional user license. 

Additionally, the InstantGMP PRO Vendor Management workflow expedites the creation of contracts describing the arrangements for each supplier’s certification, allowing content interactivity as needed.

If you would like to know more about how we address these Qualified Person tasks, just reach out to us, we’re qualified.   www.instantgmp.com

References

https://eur-lex.europa.eu/legal-content for the directives

ECA Academy, “ECU Annex 16: Certification by a Qualified Person and Batch Release”, ECA Foundation, Mannheim, 2023 

“The Role and Duties of the EU Qualified Person (QP)” NSF-DBA presentation by P.Monger and A. Caudle, February 2019

“The European Qualified Person-What’s it All About?” Wolfgang Schmitt, VP, Concept Heidelberg, 7/2021