POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 163

purification steps. The test function and acceptance criteria might be confirmation
of material along with weld inspection. However, what if the material is more
corrosive, with no further purification? Then, the test function might include more
extensive confirmation, perhaps metallurgic analysis along with a higher level of
inspection.
7.3.12 Qualification Plan Implementation Notes
7.3.12.1 Subject Matter Experts SMEs are responsible for the preparation of
respective qualification documents and plans. The ASTM E2500-07 Standard
Guide defines SMEs as “ individuals with specific expertise and responsibility in
a particular area or field ” ... who “ should take the lead role in the verification
(commissioning and qualification) of manufacturing systems as appropriate within
their area of expertise and responsibility ... includ(ing) planning and defining ver-
ification strategies and acceptance criteria ... [16]” As such, it is important that
the SME has a good understanding of the individual and collective risk and
impact of systems on process performance and product quality. SMEs should
participate in risk and impact assessments, and use product quality risk as a
decision-making criteria.
7.3.13 Risk-Based Design Review
Merely testing the system for proper function is often not sufficient to con-
firm reliable and suitable function. An essential part of a risk-based qualification
approach includes review of the facility, equipment, or system design. In a risk-
based review, the reviewer should focus on those characteristics or aspects of
the design that can affect product quality. The review should confirm that user
requirements and quality specifications have been addressed in the design of
the system. The basic user requirement may require that a process transfer line
be cleanable and drainable. Therefore, the design should include smooth, non-
reactive materials of construction, welds, slope, and sanitary fittings. This can
be determined during the design review. Later, tests can be incorporated in the
qualification or leveraged from prior information to confirm these aspects of the
installation.
A design review should familiarize the reviewer to the layout of the system,
including those characteristics that could affect the qualification test and infor-
mation gathering. Attention should be on installation of systems that may be
covered by walls or otherwise may not be easily viewed after construction, e.g.,
utility piping, transfer lines, duct work, wiring, slope of insulated line, etc. The
incorrect installation of these components may pose a risk to product quality and
should be confirmed. Confirmation may need to be performed before construction
completion or the qualification team may need to leverage or rely on construction
installation information rather than direct observation.
A design review should also confirm or identify sampling ports and places for
line transporting fluids, steam, gases, and other materials. A qualification test may