Biomedical Engineering Reference
In-Depth Information
40.5
attachment form
abc Pharmaceutical comPany
Level 3
SOP No.: QAS-
Issued on:
Revision No.:
Initiator name:
FORMAT I
QUALIFICATION REQUIREMENT MATRIX (FOR UTILITY)
Each utility within the scope of this document must be assigned a qualification level based on the
use and application of the utility. Qualification and requirements details are as follows:
level 1
level 2
level 3
Criteria
The following utilities are
classified as level 1:
• Water for injection
• Puriied water
• Clean steam
• Other, as designated by
the QA manager
The following utilities are
classified as level 2:
• Product contact compressed
gas system
• Bulk solvent (product
contact/ingredient)
distribution systems
• Water pre-treatment systems
• Autoclave/retort cooling water
for parenterals
• Nutritional ingredient water
and culinary steam
A utility that requires
qualification as defined by
the QA manager.
Examples may include
• Selected waste
removal/processing
systems
• Selected vacuum
systems
• Selected nonproduct
contact utilities
Initial
requirements
• IQ/OQ/PQ
• Establishment of system
on extended monitoring
program (for
pharmaceutical water
systems)
• IQ/OQ/PQ
• IQ
• Other, as determined
by QA manager
QUALIFICATION REQUIREMENT MATRIX (FOR EQUIPMENT)
level 1
level 2
level 3
Criteria
Equipment where an
undetected change in
equipment performance
poses a significant risk to the
product
Equipment where a change that
may be detected in equipment
performance poses a significant
risk to the product
Packaging equipment
Initial
requirements
• IQ/OQ/PQ
• IQ/OQ
• Other (PQ) by QA manager
• IQ
• Other (OQ, PQ), as
determined by QA
manager
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