3Qualification and Validation Clause Samples

3Qualification and Validation. 3.3.1 Halo shall ensure that product related manufacturing/process equipment, analytical equipment, computer systems with quality impact, and other testing, measuring, calibrating equipment are qualified before use, and results are documented. 3.2.2 Halo shall qualify and routinely monitor systems with quality impact such as air handling, water system, compressed air and gas supply. 3.3.3 Halo shall ensure that all product related instruments are identified and calibrated on a frequent basis using recognized National or International standards. If external calibration agencies/contractors are employed, Halo shall ensure that personnel involved are trained prior to performing the task. 3.3.4 Halo shall qualify and routinely monitor product manufacturing area and packaging environment for particulate matter, microbial counts. Product related cleaning processes shall be validated/verified for common equipment, but may be verified for product contact surfaces of equipment dedicated to Tapentadol manufacturing, based on Halo’s procedures.