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Sr. Manager, Quality Control, Biocon Ltd
Agenda
Introduction
Equipment/Instrument
Qualification
Equipment/Instrument
Calibration
Conclusion
Equipment/Instrument - Classification
All analytical devices can be classified under 2 categories
viz. Equipment and Instrument.
Identification of Causes
Training of analyst for calibration procedures.
Glassware/Standards – Cleanliness, Validity etc.
History of malfunction/breakdown and maintenance.
Review of previous calibration report.
Out-of-Calibration Procedure - Contd