To provide a procedure for Qualification Protocol for QC Instruments.
2.0. SCOPE :
The procedure covers all the instruments used in the quality control department.
3.0. RESPONSIBILITY :
6.1. Protocol on validation should be prepared for installation of any new equipment or instrument.
6.2. Protocol should describe the following points
6.2.1. Name of the instrument
6.2.2. Code No. of the instrument
6.2.3. Instrument manufactured by/ supplied by.
a) Catalogue No.
b) Serial No.
c) Size of instrument( Height x Length x breadth)
d) Supply of power by AC/DC
6.2.4. Validation/Calibration required
6.2.5. Frequency of Validation/ Calibration.
6.2.6. Installation and Validation report
6.3. Instruments must be validated depending on its purpose and use.
6.4. Protocol will give information for preventive maintenance.
6.5. It should be documented in case of deviation or modification made to the instrument
Instrument Manual, SOP:QCGN:xxx