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.
