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A Practical Guide To Construction, Commissioning and Qualification Documentation - and Its Critical Role in Achieving Compliance
A Practical Guide To Construction, Commissioning and Qualification Documentation - and Its Critical Role in Achieving Compliance
A Practical Guide To Construction, Commissioning and Qualification Documentation - and Its Critical Role in Achieving Compliance
construction
G
ood documentation is essential for Naturally, the initial focus must be on the
pharmaceutical and biotech manufac- proper construction and start-up of the facility.
turing facilities to achieve regulatory Yet, a well-constructed facility that is on time,
compliance. As defined by the Food within budget, and whose every system is per-
and Drug Administration (FDA), Validation is forming to specifications is of no value to the
a documented program providing a high degree operating company if the associated documen-
of assurance that a process/system consistently tation does not effectively support the qualifi-
meets pre-determined specifications. The clear cation process it is a classic case of failing to
presumption is that if the required activities see the forest through trees. In fact, the con-
have not been properly documented, then they struction contractor must appreciate the sig-
have not been performed. nificance of documentation, and make it an
integral part of the con-
Figure 1. Validation life
cycle. struction planning, im-
plementation, and com-
missioning process from
day one.
Note: the term Con-
struction Contractor is
used to indicate a third
party company respon-
sible for construction,
commissioning and qual-
ification. This article fo-
cuses on construction
contractors who can de-
liver qualified facilities.
It also presents the ad-
vantages of using a con-
struction contractor who
can perform C&Q, as well
as construction led rather
than design led projects.
A full service provider
could provide all of these
activities. These activi-
ties could be provided in