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Validation Services

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Area Qualifications 

Installation Qualifications

Operation Qualifications

Performance Qualifications

cGMP Compliance

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).

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