Operational Qualification of HPLC (High Performance Liquid Chromatography)
In this post we learn Operational Qualification of HPLC (High Performance Liquid Chromatography) in Pharmaceuticals Quality Control Laboratory.
1.0 OBJECTIVE
To assure that the equipment used for analysis, is operated, and qualified according to the specifications mentioned in the equipment catalog and complies with company and regulatory standards and guidance Operational Qualification of HPLC (High Performance Liquid Chromatography).
2.0 SCOPE:
This protocol applies only to “High-Performance Liquid Chromatograph 1260 series” for its Operational qualification.
Qualification of support utilities is not within the scope of this qualification protocol.
3.0 REFERENCES
Validation manual/ Validation Master Plan
SOP for QA/ QC Equipment Validation
Operator’s Manual
4.0 EQUI...