Implementing a Pharmaceutical Quality System
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
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.
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