Since the start of our company in 1999 Progress has offered strong expertise in cGMP regulations. Our regulatory expertise has since expanded to other quality regulations, such as Biological Safety (BSL), specific requirements for radiopharmaceuticals, and ISO compliance.
Progress can offer full support to companies who want to develop a business case to implement or update a Quality Management System (QMS), whether GMP or ISO based. Every company wants to improve internal business processes, and strives to provide the best service to their customers. A properly implemented QMS will help you reach that goal.
Laboratories that perform release testing of (bio-)pharmaceutical products require a GMP certification. For most other purposes laboratories will benefit the most from having their organization ISO-certified. In some cases the customers may require ISO certification or consider it highly advantageous in a preferred supplier. For testing laboratories specifically ISO17025 is applicable, and in order to be granted an ISO17025 certificate multiple chapters of ISO9001 must be included. Therefore, both ISO17025 and ISO9001 will be taken into account here.
The current ISO9001 ‘general Quality Management Systems’ and ISO17025 ‘General requirements for the competence of testing and calibration laboratories’ will help improve overall performance and provide a sound basis for sustainable development initiatives.
Obtaining and maintaining a certification should not be a bureaucratic exercise; instead it is a set of documentation which will support standardization of processes in a LEAN way and stimulate continuous improvement.
To summarize, the following topics will be addressed in a QMS:
- Planning and support
- Operation (development as well as commercial manufacturing/servicing)
- Performance evaluation
- Validation of methods and testing
This is certainly not just applicable to ‘mature’ companies, as in our experience it has proven very useful for start-ups and scale-ups as well.
We can provide advice and support from the very beginning until the completion of the certification process. Our ISO services include:
- Performing gap analyses (business cases)
- Delivering documentation
- Project management
- Staff training
- Performing ad-interim Quality Management roles
- Implementing Lean Six Sigma and Agile tools and practices
To set up and/or improve a QMS for optimum effectiveness and company success a combination of requirements and cultural behavior (hard and soft skills) is required. The current labor shortages in the Netherlands also call for standardized, efficient and lean processes.
Depending on the scope and effort, a certification is usually feasible within one calendar year.
Our team of 50+ consultants with deep and extensive experience assures availability of a wide range of expertise. Each project will be supported by the complete knowledge base and wealth of experience available within Progress.