As in the case of all qualifications, the risk analysis is carried out to consolidate the knowledge of all the parties involved and define the necessary test and action points required for the qualification. This is an extremely time-consuming process. Tools (e. g. cause and effect diagrams, FMECA) and design documents should be used to create a risk analysis. Design documents can include:
When a risk analysis is carried out, whether the process or the equipment is being analysed needs to be defined. Both analyses are necessary. The process, and especially the quality of water required for use, can be assessed by the pharmaceutical manufacturer. The resulting requirements are included in the user requirements specification. The system manufacturer can assess the equipment. This means that knowledge is shared between the operator and the system manufacturer when the risk analysis is being created.
Theoretically, it should be carried out at the very start of a project. This is often difficult because some of the information required for a complete process risk analysis is frequently not yet available at this stage. A rough analysis at least is usually required to identify the system requirements for the user requirements specification. A possible solution is to carry out a rough initial inspection before the user requirements specification is created. The knowledge acquired should be sufficient to create the user requirements specification. After the contract has been awarded, a second version of the risk analysis is created as soon as the system manufacturer has provided all the relevant information about the design.
It should also be defined at the start of the risk analysis whether only quality-related features are to be covered by the risk analysis, or whether commercial and/or safety-related risks are also to be documented. In this case, the quality-related points should be labelled as such. They are transferred to the qualification plans at a later stage. Other test points are checked during commissioning.
The FMEA for a WFI system works exactly like it does for a PW system, and the same issues have to be taken into consideration. The main differences relate to the technology used during the process and the increased criticality with regard to microbiological parameters. The risk analysis can result in sampling being required more often than is the case for a PW system and in narrower action/warning limits.
The risk analysis should also provide answers to the following questions that are not always considered:
The risk analysis for a pharmaceutical water system is generally a very substantial document. The structure of a risk analysis and the general risk analysis process are shown in the sample document 1 Risk analysis (extract).
Sample document 1 Risk analysis (extract)
This text is an excerpt from the GMP Series Download Qualification of Pharma Water Supply Systems
Degree in Environmental Engineering/Environmental Metrology
Merck KGaA, Darmstadt
Pharmaceutical water is the most important of all pharmaceutical utilities. It plays a pivotal role in pharmaceutical processing. Therefore, thorough and proper qualification of water systems is highly essential for ensuring that the pharmaceutical manufacturer uses the right quality of water.
In Qualification of Pharma Water Supply Systems you’ll get answers to the questions:
What's more, you will get sample documents (plans and reports) for all qualification stages!
Avoid pitfalls and order Qualification of Pharma Water Supply Systems now!