ABSTRACT
The design, construction, and commissioning of a new
facility for the pharmaceutical industry is a complex
process that involves the interaction of a wide variety of
engineering, process and QA, and control disciplines and
may proceed through a series of different phases from a
conceptual, feasibility study, through to the final detailed
design, construction, commissioning, and final site vali-
dation activities. The FDA’s risk-based approach to GMPs
for the 21st century has changed the industry’s perspec-
tive to validation and qualification. This new initiative
allows the facility designer, constructor and commis-
sioning group to take a risk-based approach to the
qualification of facility and equipment. The basic require-
ments for validation of facilities and equipment are
defined in both the European community’s Guide to
Good Manufacturing Practice Vol. IV (Medical Products)
and the United States’s GMPs CFR Title 21 (1,2). These
documents clearly define the need for a whole system
that is based on QA. This is essential for pharmaceutical
companies to ensure that products meet their quality and
marketing authorization requirements. cGMP is a key
element of an overall QA system and GMP extends
through people, production, premises, and equipment.
Both the U.S. GMP and the EC Guide emphasize that
premises and equipment should be designed to be
appropriate and fit for the purpose. Interpretation of
this statement implies that it is essential that facilities
must be built to standards that meet the requirements of
the GMPs and be demonstrated to meet these require-
ments. The process of validation is a key component
within the concept of QA and GMP. The consequence of
this for the facility designer is that he or she must use
design and engineering methods that will comply with
and demonstrate that the facility, when complete, does
meet the requirements of cGMPs.
