PRECAUTIONS & GENERAL INSTRUCTIONS IN MFG AREA

PRECAUTIONS & GENERAL INSTRUCTIONS IN MFG AREA

  • Ensure area and equipment cleanliness before starting the manufacturing operations.
  • Check and ensure that all manufacturing equipment and other required accessories are clean and ready for use.
  • Wear Gloves and Nose masks during all manufacturing processes.
  • Counter-check the weights of all ingredients before using them in the batch.
  • Get line clearance from QA for manufacturing.
  • AHU system should be kept ON throughout the manufacturing process.
  • The temperature should be kept at NMT 27°C. Check and maintain a record of temperature at least twice in a shift.
  • Always transfer Solvents to the manufacturing vessel through 200-mesh nylon/Muslin filter cloth. The integrity of the nylon filter cloth is to be checked before and after use.
  • During the preparation of this product, no other product processing should be done in the same area.
  • All critical aspects during manufacturing like temperature, duration of mixing, weight, etc. must be checked and recorded by the supervisor.
  • Supervisor to ensure completion of all in-process records during various stages of manufacturing operations till completion of the batch.
  • Release from QA should be taken for all in-process tests mentioned in the batch manufacturing record.
  • No overwriting is allowed in the Batch Manufacturing Record. If the initial data is wrongly entered, cancel the data with a single stroke across and initial. Record reasons for change as a footnote on the same page. Other procedures follow as per Good Documentation Practices.
  • All the details whatever is necessary should be recorded in Batch Manufacturing Record.
  • Send a Sample with a Sample intimation Slip to QC after manufacturing is completed.
  • Check all polyethylene bags before & after material loading for black particles.
  • Check the calibration of the respective equipment/machine before use. 
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