EQPA Tool Box - Introduction

Content

1 Introduction/Scope ........................................................................................................................... 3
2 Development of the Tool Box ........................................................................................................ 3
2.1 DOCUMENT HISTORY ............................................................................................................................3
2.2 CONTINUAL DEVELOPMENT....................................................................................................................3
 EQPA Tool Box

Document History

Date of Publication
Version 2.0 06 June 2018

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 EQPA Tool Box

1 Introduction/Scope

The European QP Association Advisory Board decided to establish a Tool Box for
QPs. The project’s goal is to promote a set of tools like example-SOPs, checklists,
decision trees and workflows.

The board emphasis in this context that release activities are site and product
specific. There is no one checklist that would cover all scenarios (even if we would
create individual checklist for all dosage forms). Different aspects related to the
nature of materials, manufacturing process, storage, transportation etc. may be
critical for different products.

So the goal is not handing over a tool box containing "off the shelf" checklists but
presenting a set of tools which can be customised and amended by QPs as needed.

2 Development of the Tool Box

2.1 Document History
The Project was initiated 2012 and members were asked to send in examples for
checklists, decision trees, workflows etc. Based on the feedback version 1 of this
document was created. In 2018 an example Standard Operating Procedure on QP
certification was integrated.

2.2 Continual Development

Members are asked to send in more examples so that these can be added to the
Tool box.

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 complete this set of generic
tools.

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