We perform risk analyses in accordance with ICH Q9 as part of the planning of qualifications and validations. In doing so, we adhere to the specifications from your SOP's, but we can also bring our own tried and tested templates. The most common method for this is an FMEA, often in combination with other types of risk analysis (e.g. cause-effect diagram, HACCP). We offer solutions tailored to your needs and always keep a sense of proportion in all activities: Only those plant or process parameters determined according to rationally justified factors that may have an influence on product safety must also be qualified or validated accordingly. This saves potential additional expense for unnecessary tests later on.
Based on the results of the risk analysis, we carry out all the tasks required in the context of a qualification on your behalf. Ideally, we can avoid duplication of work and costs by referring to GMP-compliant documented tests, e.g. from previous commissioning tests.
This includes the planning, execution and reporting of the four qualification phases:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
In addition, we also offer to prepare the required qualification master plans for your operation.