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Topic insight: Implementation of EU-GMP Annex 16 at H. Lundbeck
Starting the project with a GAP analysis revealed that a number of Lundbeck’s procedures would have to be updated in order to be in compliance with the requirements of the revised annex 16. The main focus areas would be certificates, quality agreements and education of our personnel.
Certificates are a challenge, since our electronic solution requires a generic approach, and affiliates both inside and outside the EU have their own requirements. Quality agreements must describe in more detail the division of responsibility between QP’s inside the EU; if outside the EU, additional requirements apply. Furthermore, a system had to be implemented insuring that all relevant knowledge is available to the pharmacist (QP delegate) when releasing product.
At Lundbeck, these requirements are facilitated by our creation of “Quality Responsible Persons”, which in our terminology means a person within Quality Assurance who is appointed as the main expert of a business area. E.g., tablet production at HQ, or CMO production worldwide. The “Quality Responsible Person” reports directly to the QP on all compliance issues within his area. At the same time, the “Quality Responsible Person” is in charge of the PQR process within the business area and is responsible for keeping the other pharmacists (QP delegates) updated on all relevant matters regarding product and procedure.
In each business area, a “Risk Register” is established and maintained through cooperation between the “Quality Responsible Person” and a representative from that business area.
The purpose of the “Risk Register” is to mitigate all risk by stating the problem and its impact, thereby enabling prioritization based on facts and facilitating the implementation process.
Each business area, e.g., sterile production at HQ, packaging at HQ and so forth, is evaluated monthly in a management report. A “Quality Index” generated by Quality Assurance addresses relevant parameters for the specific business area. It is typically influenced by parameters such as deviations or rejected batches, but it is also linked to the “Risk Register”, and management is thereby involved directly in the prioritization and risk mitigation.
The implementation of EU-GMP Annex 16 at Lundbeck was facilitated by these processes.
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