FDA | OSHA | SQF | BCAS | NFPA 1989 | ISPE
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Validation Services
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Area Qualifications
Installation Qualifications
Operation Qualifications
Performance Qualifications
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AREA QUALIFICATIONS:
For detailed temperature and relative humidity mapping including identification of hot & cold points as per Class-A cGMP cleanroom.
Following (FDA) requirements.
INSTALLATION QUALFICATIONS:
For process equipment’s including V-Cone Blenders, homogenizers, conveyers. Utility equipment’s such as to air compressors, boilers, process water chillers, AHU’s.
OPERATIONAL QUALIFICATIONS:
Utility equipment’s such as air compressors, boilers, process water chillers, AHU’s
PERFORMANCE QUALIFICATIONS:
Utility equipment’s such as air compressors, boilers, process water chillers, AHU’s. In addition, customized as per Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs.)
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Please Note: Report submissions will be processed as paper-based system with handwritten black ink readings stamped & signed with exact date and time. Quality Data standards will be maintained as per ISO 9000 (QMS compliance).