Definition used in Pharmaceuticals : Batch Number : A distinctive combination of numbers or letters from which the complete history of the manufacture, processing, packaging, coding and distribution of a batch can be determined. Documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch or lot which include Dispensing of raw material, Granulation, Blending Compression, Capsule Filling, Coating, Inspection and yield at different stages. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity. Batch Packaging Record : Documentation that provides the history of a batch from packaging material dispensing, Blister packing, Bottle packing, Jar packing, Dry syrup Filling, labeling, Carton packing and shipper packing up to ...
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements. list of instruments calibration in pharma industry: Thermo-Hygrometer Weight Box (E2 Class and coarser) Temperature controller / Indicator Autoclave Mapping Micro pipettes ORP Meter Temperature Mapping Weighing balance Data Loggers Humidity Mapping Glass wares Safety Valve Incubator Hydrometer Magnahilic Gauge Oven Measuring scale Manometer Glass thermometer Caliper Pressure gauges Thermocouples / Temperature Sensor Wobble meter Compound gauges Muffle Furnace Dial gauge Pressure recorder Anemometer Lux Meter Hot-Wire anemometer Temperature recorder Temperature transmitter Pressure Transmitter Humidity transmitter Test sieve Dial Gauge
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