POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 130

requirements in Subparts C and D of 21 CFR Part 211, the cGMPs for assur-
ing proper design and function—the link to product quality and the requirement
stated in other sections, including 211.22, which assign the responsibility for
control of quality to the quality unit. These recommendations and requirements
reinforce the need for quality oversight of those efforts that qualify facility and
equipment design and function, which have the potential to adversely affect
product quality.
Following this logic, facilities and equipment that support critical process steps
and, therefore, whose failure would have an adverse affect on product quality
must be qualified and that qualification and acceptance criteria must be approved
by the company's quality unit. Having said that, it would then be logical that
the function of those facility and equipment systems that do not support critical
process steps or the failure of which would not adversely affect product quality
do not have to be qualified. It is still prudent to have confidence that these
systems are installed and operating to specification and expectation. This can be
accomplished through commissioning efforts. In this case, these commissioning
efforts or their acceptance criteria would not have to be approved by the quality
unit.
In performing risk assessments, one should assemble as diverse a team as
practical. Team members should include relevant stakeholders who can contribute
to the assessment. It may not be necessary to include all stakeholders, if they
do not have such information or input. The quality unit, laboratory, engineering,
manufacturing, process development, technical support, validation, and others
may have information and input that are beneficial to the assessment effort and
therefore should be considered for inclusion on the team. The risk assessment
is an exercise to determine and mitigate risk elements. While it is not specially
designed to be a communication effort, it can still effectively work as such.
In that context, having quality involved in the early stages should allow for a
better understanding of the rationale on which decisions are based. The use of
a diverse team provides valuable input and also reduces the potential for biased
conclusions.
The quality unit has the responsibility to assure product quality and therefore
to approve the testing approach, acceptance criteria, and conclusions of the qual-
ification study, including data received from sources directly represented in the
qualification. As such, they will have a role in the transfer of qualified systems
to commercial manufacture and should be included in the planning and final
approval of qualification efforts.
7.1.4 Role of Commissioning in Risk-Based Qualification
The relationship between engineering, construction, commissioning, and qualifi-
cation phases of a new system or equipment project are illustrated in Figure 7.2.
Engineering represents the phase where design requirements are determined and
systems and equipment are designed. Construction represents the phase where