Logfile 32 Qualification Water Supply Systems

LOGFILE 32 / September 2018 Maas & Peither AG – GMP Publishing
Risk analysis of a pharmaceutical water system

An excerpt from the GMP Series Download Qualification of Pharma Water Supply
Systems
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.
http://www.gmp-publishing.com
© 2018 Maas & Peither AG – GMP Publishing, Schopfheim, Germany, All rights reserved Page 1
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)
Author:
Fritz Röder
Degree in Environmental Engineering/Environmental Metrology
Merck KGaA, Darmstadt
This text is an excerpt from the GMP Series Download 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!
Avoid pitfalls and order Qualification of Pharma Water Supply Systems now!

Logfile 32 Qualification Water Supply Systems

Uploaded by

Copyright:

Available Formats

Logfile 32 Qualification Water Supply Systems

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Logfile 32 Qualification Water Supply Systems

Uploaded by

Copyright:

Available Formats

LOGFILE 32 / September 2018 Maas & Peither AG – GMP Publishing

Risk analysis of a pharmaceutical water system

Sample document 1 Risk analysis (extract)

In Qualification of Pharma Water Supply Systems

• How is the qualification of a water supply system

You might also like