1.0 Purpose : To provide instructions for record maintained by quality control department.
2.0 Objective : To provide a documented procedure for record maintained by quality control department.
3.0 Scope : This procedure is applicable for record maintained by quality control department --- Pharmaceuticals Ltd.,
4.0 Responsibility :
· Primary : QC Chemist / QC Officer
· Secondary : Overall : QC In Charge
5.0 Procedure :
· Following are control documents.
Ø Standard Operating Procedures of Quality Control Department..
Ø Specifications of Raw material.
Ø Specifications of Packing material.
Ø Specifications of In-process / intermediate.
Ø Specifications of Finished product.
Ø Standard Test Procedures of Raw material.
Ø Standard Test Procedures of Packing material.
Ø Standard Test Procedures of In-process / intermediate.
Ø Standard Test Procedures of Finished product.
Ø List of Instruments.
· Following are records.
Ø Raw materials testing records.
Ø Packing materials testing records.
Ø In-process / intermediates testing records.
Ø Finished products testing records.
Ø Instrument calibration records.
Ø Stability study records.
Ø Instrument calibration records.
Ø Glassware calibration records.
Ø Raw material inward logbook
Ø Raw material work sheet issuance logbook.
Ø Intermediate inward logbook.
Ø Intermediate work sheet issuance logbook.
Ø Finished product inward logbook.
Ø Finished product work sheet issuance logbook.
Ø In process samples inward logbook.
Ø Instrument uses logbooks.
Ø HPLC column logbook.
Ø Stability chamber logbook.
Ø Laboratory cleaning logbook.
Ø Volumetric solution logbook.
Ø Standard reagent solution logbook.
Ø Indicator logbook.
Ø Retention sample logbook.
Ø Logbook issuance logbook.
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