HOLD TIME STUDY

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Fish Bone Diagram or Ishikawa diagram (Cause and effect diagram)

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Fish Bone Diagram or Ishikawa diagram (Cause and effect diagram) : Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa, who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. The defect is shown as the fish’s head, facing to the right, with the causes extending to the left as fish bones the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required. Analysis of Fish Bone diagram: Man: Educational Qualification Experience Association with Company Workload 2. Machine: Qualification Preventive Maintenance Breakdown Calibrations 3. Measurement: Inprocess checks Release testing Control sample testing Stability testing 4. Material: Raw material (API& Excipients) Packing materials Semi finished Goods 5. Method: Dispensing Sifting 6. Environment: D...
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Why Three consecutive batches taken for Validation

Consecutive meaning following closely with no gap or following one after another without interruption. The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so  depends upon that manufacturer have to choose the number of batches to be validated. If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data  between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred. Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation. Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points requir...
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