1.0 PURPOSE
To lay down the procedure for usage of equipment and its design.
2.0 SCOPE
2.1 This SOP is applicable in Production and Quality Control
3.0 RESPONSIBILITY
3.1 Quality Control Personnel
3.2 Production Personnel
4.0 ACCOUNTABILITY
4.1 Manager - Quality Control
4.2 Manager – Production
5.0 PROCEDURE
5.1 Manufacturing and testing facility shall have equipments suitable to serve
the intended purpose.
5.2 Design of the manufacturing equipment shall meet the process and cGMP requirement so as not to alter the quality safety, purity and strength of the product.
5.3 Contact surfaces of manufacturing equipment shall not be additive or absorptive to the material processed in the equipment.
5.4 Precaution shall be taken to prevent the contamination of contact surface with prescribed lubricant.
5.5 Process Capacity, cleaning of contact surface, product and process containments and feasibility of validation for equipment performance shall be considered in the design of equipment.
5.6 Design of testing equipment shall be suitable to provide the accuracy, reproducibility and repeatability in the testing results.
5.7 Design specification of all critical manufacturing and testing equipments shall be approved through design qualification program.
5.8 All critical equipments shall be qualified for its installation, operation and/or performance before its use in manufacturing or testing.
5.9 All equipments and subparts of equipments shall be identified with code number.
5.10 Standard Operating Procedure shall be prepared for operation, cleaning and preventive maintenance of all critical manufacturing equipment.
5.11 Standard Operating Procedure shall be prepared for operation and calibration of all critical testing equipments.
5.12 Maintenance of testing instruments shall be carried out by competent external services with a annual maintenance contract.
5.13 Measuring instruments which are attached to the equipment and critical to product quality and performance of equipment shall be calibrated at a prescribed schedule as per calibration master plan.
5.14 All operations of the equipment shall be recorded chronologically in Equipment Usage Log as per Annexure I
END OF DOCUMENT
Usage policy, quality assurance, prescribed lubricant
