In 2012, KPC International was contracted by a multinational client based in Hungary to provide support in bringing Commissioning and Qualification back on schedule and to provide guidance and support for Post OQ – manufacturing start-up activities.
An overview of the specialist services provided by KPC International is as follows:
- Commissioning & Qualification
- Quality & Compliance
- Project Management
- Technology Transfer
- Operational Readiness
The KPC International approach was designed with a focus on people, process and innovation in mind. This meant integrating our team of engineers with client and other on site providers, and implementing knowledge sharing between the teams to achieve a successful project outcome.
This approach included:
- The application of lean and risk based strategies to reduce the workload
- A mix of youth and experienced consultants for additional expertise on an ‘as required’ basis
- The development & implementation of a strategy to run the DSP at EM level, and later test the operational layers, thus saving the schedule for product manufacture
- The incorporation of operations and maintenance personnel into C&Q execution, SOP development and maintenance and spare-parts management
- The development of Risk based SIP PQ & Cleaning Validation strategy, with a view to the ultimate site goal of a multi-product facility
- The development of process validation and Batch data analysis & reporting with regulatory submission in mind
- The sharing of knowledge and experience with the client; eg providing guidance on operational readiness, investigations, quality systems, preventative maintenance , shipping qualification, project management etc
Through this approach, KPC International delivered a successful project outcome for our client, achieving a plant start-up with no batch failures.
KPC International’s innovative strategies and approach were highly commended by Senior client management teams and other leading consultants.