22.08.2018 | LOGFILE Feature 32/2018

An excerpt from the GMP Series PDF Download Qualification of Pharma Water Supply Systems

Risk Analysis of a Pharmaceutical Water System

5 min. reading time | by Fritz Röder


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:

  • flow charts
  • layout plans
  • process descriptions
  • historic data from existing systems
  • bills of materials
  • other documents

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:

  • What are the critical (quality-related) process parameters? Where and how often are they checked?
  • Where are the sampling locations for microbiological monitoring and how critical is sampling at the point of withdrawal? (This is used to define the sampling frequency at a later stage.)
  • Which maintenance activities are GMP-related?
  • Which points must undergo calibration?
  • What are the warning and action limits for the quality-related parameters? (Please note: there are usually increased bacterial counts downstream from a softening system because of the immense surface area. It makes sense to define a higher warning/action limit for this location.)
  • How is the potential entry of air into the product water handled? Is it critical for the application?
  • How is QA informed when quality-related system malfunctions occur?
  • How is the sanitation concept tested (e g. heat distribution tests or measurement of ozone)?

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

Fritz Röder


Fritz Röder
Senior Manager validation, qualification & engineering bei Merck KGaA
E-Mail: roederfritz@googlemail.com

Qualification of Pharma Water Supply Systems

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.

But the qualification of a water treatment system is extremely comprehensive. Engineer and water expert Fritz Röder will lead you safely through the whole process of DQ, IQ, OQ and PQ.

In Qualification of Pharma Water Supply Systems you’ll get answers to the questions:

  • How is the qualification of a water supply system organised?
  • What requirements must the qualification of a water supply system meet?
  • When can the water be used for the manufacture of medicinal products?
  • What does a typical risk analysis involve?
  • What do the qualification documents contain?
  • How are warning and action limits determined?
  • How is sampling organised and carried out during the qualification?

What's more, you will get sample documents (plans and reports) for all qualification stages!

> More information and order