Risk analysis (RA) has become an essential tool to ensure a high quality level in pharmaceutical manufacturing and quality control thus a central claim of the EU
& FDA GMP requirements for qualification and validation.
By means of risk analysis, all aspects of pharmaceutical manufacturing can be subject to a formal review of process risks including product quality, operator safety, and process stability.
Valicare uses risk analysis for your qualification project e.g. of manufacturing equipment, process and cleaning validation and for assessment of the
21 CFR part 11 compliance of your IT systems.
A risk analysis prepared by Valicare will comprehensively identify and document risks, and furthermore, develop solutions that can reduce or eliminate the identified risks and minimise the scope of the subsequent qualification testing.
Valicare generally uses Failure Mode and Effect Analysis (FMEA) methodology to complete Risk Analysis. The implementation includes three steps:
- Step 1
Describe functions and malfunctions, identify applicable sensors, and relate them to the functionality of the system or failures during specific process steps.
- Step 2
Assessment of the failures, and the relative risk for product quality, operator, and equipment safety.
- Step 3
Preparation of an action plan which categorically lists items to be included in SOP’s, IQ testing, OQ testing, and other qualification documents.
Results are recorded in our thorough format, or in your own specified format as required. Other
risk-assessment tools, such as HACCP are also common to be used.
Conclusions drawn from the risk analysis process can then be applied to the Requirements Traceability Matrix
(RTM) and tracked individually throughout your qualification and documentation.
