POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 132

that are reliable and suitable. The systems must be well designed, fabricated, and
installed. They must be qualified to assure that their function meets expectations.
To be able to claim this, the systems should be commissioned to verify that they
are working properly and fit for use. The certainty of function of a system can be
obtained through design assessment (design qualification, design review), testing
(data acquisition), and the accumulation and evaluation of design, installation,
and operation-related information. The extent and effort of qualification should
be commensurate with the level of risk to product quality.
Qualification provides documented evidence that items, systems, and processes
are suitable for their intended purpose. These things must function in compliance
with regulations. There should be an understanding of the correlation between
the function and its impact on the quality, safety, efficacy, strength, or identity of
the product. The confirmation through a formal documentation procedure proves
that something is capable of its intended performance. Commissioning and FAT,
which are similar to qualification, can ensure acceptable qualification results and
if performed and documented properly may be used to supplement qualification
efforts.
Systems supporting product-quality-related processes should be commissioned
and must be qualified. Because companies possess limited resources, it is pru-
dent to prioritize the qualification of those systems based on their effect on
product quality. All systems affecting product quality should be qualified; how-
ever, qualification efforts and related acceptance criteria should be commensurate
with the level of risk associated with their respective process step or equipment
function.
Before a system can be qualified it must be in good working order. Systems
that are not in good working order are unreliable and may pose a risk to product
quality through malfunction. Commissioning confirms that facilities, equipment,
and systems are functioning properly. The ISPE defines commissioning “a well-
planned, documented, and managed engineering approach to the start-up and
turnover of facilities, systems, and equipment to the end-user, that results in a
safe and functional environment that meets established design requirements and
stakeholder expectations [7].”
Commissioning may involve the start-up of equipment and getting the equip-
ment to function correctly as expected. Once it has been started up and working
properly, qualification approaches can be used to confirm or assure that the system
functions the same way consistently, reliably, and predictably.
The relative effect on product quality of a system's function can be obtained
through analysis of relative risk and impact of that function on product qual-
ity. This can be accomplished through a risk assessment or through an impact
assessment. The consideration of relative risk and the use of risk assessment
and risk management are essential to making decisions related to the commis-
sioning and qualification of facilities and equipment used for the manufacture of
pharmaceutical products.