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6 September 2012

Qualified Person Association plans on developing "Tool Box for QPs"

The European QP Association is regularly contacted by members asking for some support for the daily work of a QP. One request frequently made is for a set of tools such as checklists, decision trees and workflows that could be used for structuring batch release decisions that would ensure all relevant points have been considered.

The European QP Association Advisory Board is fully aware that release activities are site and product specific and may differ according to the structure of the Pharmaceutical Quality System (PQS) in place. As a consequence, there cannot be a “one size fits all” checklist even for one particular dosage form.

The European QP Association Advisory Board has decided to respond to the members’ requests by attempting to establish a generic ‘Tool Box for QPs’. They wish to consider all aspects relating to the control of starting materials, manufacturing processes, warehousing, transportation etc. which influence different product release scenarios. The EQPA goal is not to develop a tool box containing a simple set of "plug in" checklists, but rather to establish a set of generic tools which then can be customised and amended by QPs as appropriate to their PQS and supply chain needs within their companies.

To expedite this project, we are looking for EQPA members who are working on or have already developed, established and implemented similar checklists, decision trees or workflows controlling processes such as

  • Batch Release
  • Batch Record Review
  • Risk Assessment
  • Supplier Qualification
  • Product Quality Review
  • others

and who are willing to share these documents with the project group. If you are willing to support this project, we would kindly ask you to send these documents to admin@qp-association.eu.

The documents will be kept completely confidential and will not be distributed to any other members. They will be collected and evaluated by the European QP Association Board and Administration exclusively to create this new set of generic tools.