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Implementing a Pharmaceutical Quality System

Based on our analysis and consultation, a start up sets up new structures and processes allwoing them to produce an operate more efficiently along the way to market.

A start-up company is confronted with the following situations:

  • There are duplicate SOPs to the same topic
  • Communication with authorities without internal consultation
  • Changes initiated at last minute without prior involvement of all involved parties
  • Consistent issues with CROs/CMOs regarding responsibilities
  • Having no internal SOP how to deal with external parties, no quality agreement, no audit, no controls, etc.
  • No ownership
  • Lack of understanding timelines to be followed in a regulated environment


Processes barely defined


Resources not adequately allocated,
no documentation system established
(double, lacking; overview)


Responsibilities (and tasks) of
department/person not sufficiently defined

PQS Implementation

Now, how to overcome the situation and be more efficient and use resources more effectively? The solution is the implementation of a robust Pharmaceutical Quality System (PQS) according to ICH Q10, which is based on the relevant ISO 9000 series.

In a series of interviews of relevant personnel, the current status and situation of a company will be determined.

In the course of this exercise

  • All processes of the company are analysed, aligned and, if necessary, redirected according to the requirements and ideas of the Management.
  • Interfaces between the processes are determined.
  • A Quality Manual will serve a basis document describing the scope of the company
  • A Management Review is going to be implemented to direct the organisation by relevant management.
  • The documentation structure is analysed and adapted to the aligned structure.