POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 164

require direct sampling of materials in lines or as confirmation of cleanliness;
there, the review should confirm that these places or ports are included.

7.3.14 Risk of Using Information before Identification of Critical Process
Parameters

One of the potential pitfalls of using early leveraged commissioning information
is not knowing the critical process parameters and operating conditions needed to
successfully perform the process. At times, the commissioning must be performed
before the process has been fully developed and finalized. If the process parame-
ters and conditions are not fully understood, then it may be possible that the tests
conducted during commissioning will not adequately challenge or demonstrate
the operating ranges. To mitigate that risk, one can perform the following:
• Test at the full capability or at an expanded operating range of the system.
• Utilize smaller scale process development studies or engineering studies to
determine most likely operating parameters and ranges.
• Repeat testing during qualification, if CPPs fall out of ranges tested during
commissioning.

7.3.15 Installation Qualification

The installation qualification confirms that the facility and the equipment have
been constructed and installed to user specification and regulatory requirements.
To do this, the installation qualification relies on the inclusion and alignment of
engineering and commissioning documentation. However, very often qualification
risk management strategies are outlined without consideration of the preceding
engineering activities. The result, if not managed properly, can undermine the
entire process late in the project where cost and schedule are adversely impacted.
For example, it is important to capture the numbering strategy used to uniquely
identify each protocol so that the equipment itself, as well as the type of protocol,
can be archived and easily retrieved for future reference. Manufacturing plants
must have efficient and effective means to retrieve historical information.
There may be a benefit to creating and using commissioning and support func-
tion templates with test details, instructions, acceptance criteria, and executable
attachments. Different functional areas may have the ability or need to change
template wording to suit specific applications. However, these changes should
not change the original intent of the tests or the acceptance criteria to an extent
that could affect the use or leveraging of the information. Consideration should
also be given to developing templates that are conducive to retesting.
Organizations vary on their level of comfort or tolerance to risk when devel-
oping and using commissioning templates. One suggestion is to outline the
execution attachments. These outlines may later be used to create the detailed
commissioning or engineering documents. The installation qualification execu-
tion attachment can then list what will be attached and referenced back to the
commissioning documents.