POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 142

7.2.7 Leveraging Risk-Based Qualification Information
Information and data used to determine if a system or item is qualified may
come from the qualification study itself or from other sources. Regardless of the
source, it is essential that this information be accurate and complete. Inaccurate or
incomplete information can lead to incorrect decisions related to the qualification
of the system. This can result in false failures and unnecessary efforts, which
presents a risk to the efficient execution of the qualification project. It can also
lead to acceptance of systems that have not been properly qualified, which would
present a risk to product quality and perhaps patient safety.
Information may be obtained from sources other than the qualification study,
including design engineers, equipment vendors, and construction or mechanical
contractors. It is often beneficial to use or leverage this information to support
the qualification study or reduce efforts.
For best results, the equipment inspection plan and a vendor audit plan should
be aligned with the project plan. Information and data obtained from engineering
and construction personnel must be accurate and should support the qualification
effort. In other words, there should be a link to product quality. It should be
reliable and follow an appropriate level of good documentation practices (GDPs).
This would be a requirement for quality unit acceptance as information to be
leveraged for qualification. The decision to leverage information and the criteria
for making these decisions should be based on risk to product quality.
Information about the installation and operation of a critical system or piece
of equipment can come from several different sources, including design draw-
ings, submittals, fabrication and construction records, FAT, site acceptance testing
(SAT), commissioning and start-up records, the historical performance data from
similar systems, and formal qualification efforts. These efforts contain the infor-
mation that can be used or leveraged for the qualification program. The source
of this information can be from a multitude of companies and disciplines such
as A&E firms; design engineers; vendors; contractors; construction workers; and
mechanical, maintenance, operations, validation, and qualification contractors.
The challenge of relying on information from sources other than those specif-
ically responsible for qualification of the facility and the equipment is that the
objectives of those groups may not be aligned with the objectives of the qualifi-
cation effort. The key to successful leveraging is the alignment of objectives of
all parties involved. The objective of vendors and construction personnel may be
different from that of the qualification effort. For those responsible for building
the facility, the objective would be completion of the construction project. Those
responsible for qualification of the facility will have the objective of providing
assurance that the equipment and system function in a manner that adequately
supports the critical process steps. This is not to say that the vendor or contractor
is not trustworthy or would deliberately provide inaccurate information. To the
contrary, vendor and contractor personnel are often very aware of and sensitive
to the need for accurate information. However, they may not fully understand the
information needed, when it is needed, in what form the information is needed,