04JA Blackburn
04JA Blackburn
practical
A Practical Approach to
approach to
commissioning
and a method of
synergy with
qualification.
Commissioning and Qualification -
Practical
applications are
A Symbiotic Relationship
explored, as by Timothy D. Blackburn, PE
well as the use
of Enhanced
A
Commissioning n initial response to the recommenda- Commissioning Streamlines
Documentation tion to perform commissioning is that Qualification
to minimize the it is just an additional step – another Effective commissioning results in a focused
roadblock to engineering success and and first-time-success validation effort. There
qualification something repeated during qualification. How- are many ways commissioning can benefit quali-
effort. ever, effective commissioning supports engi- fication – reduce costs (but don’t overstate), a
neering and qualification success. This article less rigorous documentation regimen (except
addresses efficient commissioning techniques for enhanced commissioning requirements),
and synergizing with qualification. Examples tests are closer to the source (suppliers, con-
presented are not all definitive, and documen- tractors, etc.) and therefore are often more
tation may exceed or not include certain ele- meaningful, debugging/trouble shooting is mini-
ments – commissioning (and qualification) must mized during qualification, faster qualifica-
be structured for the project. tion, catch problems qualification might miss,
Figure 1. A commissioning
documentation hierarchy.
User requirement
specifications
Factory Acceptance
Test
Site Acceptance Performance
Test Qualification
Operational
Functional Qualification
Requirement
Specifications
Installation
Qualifications
Establishing Commissioning and Typical Commissioning Documents may include the fol-
Documentation Requirements lowing, depending on project complexity - Figure 1.
Before developing commissioning documentation, establish
the extent of commissioning needed, and design efficient and • Overall Commissioning Plan - for large and more complex
effective commissioning around the needs of the project projects - this is a master plan for commissioning when the
(hopefully as expressed in a well-written URS/FRS.) Effec- approach needs preplanning and structure. On smaller
tive commissioning documentation defines the commission- projects/single equipment, consider relying on Standard
ing process (with signatory approval when needed), defines Operating Procedure (SOP) requirements rather than a
setting to work verifications, inspections, and tests; may separate overall Plan.
confirm training completion (the project is not complete until
users know how to use it); and may confirm documentation • Pre-Commissioning: includes Factory Acceptance Test
turnover (the project is not complete until drawings, specs, (FAT), Site Acceptance Test (SAT), and possibly other
and O&M manuals are turned over to record/as-built condi- early inspection/test activities. These are usually struc-
tion and enable users to operate/maintain). tured for individual systems, and can be included in or
quire validation, and other aspects (indirect impact and no tion.) Design is the value to which the equipment or system is
impact) can be commissioned in accordance to Good Engineer- designed. Normal operating is the range, wider than design,
ing Practice in lieu of an overstated qualification protocol. at which a pre-alert could occur for maintenance notification
– this could be the commissioned range. Even wider is the
SMART Commissioning and Qualification operating or validated acceptance range. It is crucial to have
Acceptance Criteria/Ranges a less stringent validated (operating) range than the commis-
Also important in synergizing Commissioning and Qualifica- sioned (normal operating) range, both of which should be less
tion and increasing the likelihood of success in both is to stringent than the design range or value. For example, if the
assign SMART acceptance criteria. The acrostic SMART is as desired validated (operating) range of a filler may be 300 vials
follows: or bottles per minute, the commissioned (normal operating
range) might be 320, and the design range 340. If the operat-
• Sensible: be practical in assigning validated ranges. Is the ing range was set at the design value or range, occasional
range really needed to ensure product quality? What does failures would likely occur. (For this example, don’t forget to
the product really require? Can the equipment deliver this also check at the lower speed during commissioning – some
range consistently? Do the ranges also meet business/ equipment may not operate properly at slow speeds.) Buffers
payback objectives? should be provided. Remember, once operating or validated
ranges are assigned, there could be a quality intervention
• Maintainable: will the range be maintained over time? required when there are excursions – obviously, this should
be avoided. Ideally, acceptance criteria should be determined
• Accurate: is the range measurable? Are realistic toler- early, and be a part of the FRS against which final commis-
ances considered? Can equipment consistently meet this sioning and qualification documents are drafted.
target?
Specific Examples
• Range: is a reasonable range assigned? Rarely can point Thus far, this article has argued the need for commissioning,
values be maintained. Design values must be well within the need to InVEST wisely and set SMART acceptance
validated ranges to minimize nuisance alarms and quality criteria, and use enhanced commissioning documentation in
intervention. the qualification effort. The remainder of the article will
cover examples of typical commissioning considerations and
• Traceable: has/can the attainment of the range be verified approaches for GMP technology and GMP utility systems.
and documented? Can it be verified later? Obviously, any application could differ, requiring more or
less of the listed considerations.
ISPE Baseline® Guides present design, normal operating, Technology systems include computer/control systems,
and operating ranges. (See Figure 3 for a graphical illustra- packaging/fill, and process/manufacturing. Typical cGMP
Summary
Commissioning documentation and qualification are symbi-
otic when properly applied. Qualification helps define what is
important for commissioning to emphasize, while commis-
sioning minimizes the validation effort and supports its
success. Remember to “InVEST” wisely (integrate commis-
sioning with qualification, verify, ensure qualification suc-
cess, sensible, traceable/document it), and set SMART accep-
tance criteria in the beginning (sensible, maintainable, accu-
rate, range, traceable). To get more information, see various
trade organizations (ASHRAE, etc.). Tried and tested GEP
approaches and documents are available, and translate eas-
ily into documented GEP commissioning and enhanced com-
missioning. Of course, ISPE has many publications avail-
able, including the “Commissioning and Qualification”
Baseline® Guide. But mostly, learn by doing.
References
1. FDA Guidelines on General Process Validation, May 1987.
2. ISPE Baseline® Pharmaceutical Engineering Guides for
New and Renovated Facilities - Volume 5: Commissioning
and Qualification, Glossary.
3. ISPE Baseline® Pharmaceutical Engineering Guides for
New and Renovated Facilities - Volume 5: Commissioning
and Qualification, Page 127.