POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 143

or even why. In addition, their time and resource commitment may be limited
to completion of their construction objective. Therefore, it is an objective of
a risk-based qualification program to ensure that those providing the leveraged
information understand and appreciate the need for accuracy and reliability.
Having said this, there remain significant benefits for using vendors and con-
struction contractors to provide qualification-related information.
1. Vendors and construction personnel may have the best understanding of the
fabrication, construction, and installation process and, as such, are subject
matter experts (SMEs) in those efforts.
2. Using this information will reduce the need for additional qualification
efforts to obtain the information, thus eliminating redundant efforts and the
risk of transcription errors.
3. Vendor and construction staff represent a significant source of personnel
early in the project and can be a highly leveraged and valuable resource.
The leveraging of information from sources other than the qualification team
should be a risk-based exercise, considering the risk of inaccurate information to
the success of the project. The decision and justification to use vendor documen-
tation to support the verification of critical aspects of the manufacturing element,
including the intended use of the manufacturing system, should be documented
and approved by SMEs including the quality unit. Therefore, deciding on the
source of qualification information is a matter of risk management in and of
itself. The factors to be considered to mitigate information inaccuracy include
the following:
• experience of the vendor/source of information;
• experience with the vendor/source of information;
• criticality or function of system being built or installed;
• availability of redundant information sources or checks and balances; and
• robustness of the vendor quality system.
When planning the leveraged use of information it is prudent to consider the
risk that inaccurate information would have on product quality, as well as qual-
ification project success. Steps may be taken to mitigate such risks. For systems
with high criticality or potential effects on product quality, it may be prudent
to employ additional qualification testing or information gathering regardless of
vendor capability. Companies may also consider audit of information obtained
from the vendor or contractor. If errors are found, then additional testing may be
necessary.
Risk assessments can be used to provide information to help determine the
extent of additional confirmation required for acceptance of vendor-provided
information. Useful information can be developed during the design, fabrica-
tion, installation, commissioning, and vendor testing phases of a project. There