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
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
- Batch Release
- Batch Record Review
- Risk Assessment
- Supplier Qualification
- Product Quality Review
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.