CASE STUDY: NUCLEAR MEDICINE
PROVIDING THE NECESSARY GMP KNOWLEDGE
01 | The starting point
Our client:
Their services:
Their end customers:
The main challenge: A lack of GMP knowledge.
When working with medical institutions, inspections by the relevant health authorities are necessary. This lead to our client encountering many problems and obstacles when clarifying situations with their customers.
The main tasks:
Engaging our specialists with knowledge of GMP,
Proposing measures to ensure full compliance
02 | Impact of the problem
There were several consequences of the issue discussed above:
User + regulatory requirements not met
Documentation issues
End customer inspections with high number of critical findings
03 | Our solution as THE FORCE
The solution for our client here? THE FORCE provided the necessary personnel to take on the role of Quality Assurance Representative and to be involved in the project as "GMP Consultants".
It should be noted that projects like this are quite complex and involve various parties such as site planners, architects, contractors, equipment manufacturers, and utility installers.
In our assigned functions, we therefore took care of:
Preparing a Qualification Master Plan
Initially, the relevant steps for the equipment qualification process were discussed to create a Qualification Master Plan. This plan
- clearly defines the different stages of the process,
- identifies the equipment, areas, and systems involved in the qualification,
- assigns responsibilities.
Creating comparability matrices for compliance
Reviewing qualification documents
04 | Results
Design Qualification (DQ) processes for most equipment successfully completed
The processes demonstrated compliance with requirements and showed few to no deviations.
Modifications to initial planning implemented to ensure continued compliance
The implementation was in line with updated European Union regulations, including Annex 1 of the EU GMP.
Project documentation managed efficiently & in accordance with Good Documentation Practices
05 | Strategies for continued success
A single project turned into 4
The strategy and support we provided to our client were well received: What began as a single project has transformed into 4 concurrent projects across 3 different countries. These projects remain ongoing, with regular meetings held among all stakeholders. Several qualification phases have already been completed successfully from a quality perspective.Ongoing support + communication
Support for our client and communication with the project managers and the commercial team will continue until all projects are finalised.Continuously building a sound relationship
Our client highly values clear communication, responsiveness in handling ad hoc tasks, and on-site visits to the end customers. This has helped and continues to foster trust as well as strengthen the working relationship.
