SELF INSPECTION CHECKLIST FOR TABLET
CHANGE ROOM
- General cleanliness
- Entry /Exit procedure
GRANULATION AREA:
- General cleanliness
- Area differential pressure records
- Equipment status
- Labeling status
- Use of protective equipment’s (e.g. Hand gloves, nose masks etc.)
- Machine use and clean log record
- Temperature and relative humidity record of the area
- Status of batch record of the product being processed
- Sieve inspection Record
- Identification of utility services
- Calibration status of Balance
- Process activities as per BMR/SOP
- Cleaning of filter Record
BLENDING AREA:
- General cleanliness
- Area differential pressure record
- Equipment status
- Labeling status
- Identification of utility services
- Temperature and Relative Humidity record
- Process activities as per BMR/SOP
GRANULES QUARANTINE AREA:
- General cleanliness
- Labeling status
COMPRESSION AREA:
- General cleanliness of corridor
- General cleanliness of IPQC lab.
- Die punch inspection record
- Die punch use and clean record
- Die-punch destruction record
- Calibration status of instruments
- General cleanliness of compression cubicles
- Labeling status of compression cubicles
- Status of batch record of the product being processed.
- Area differential pressure record
- Temperature and relative Humidity records
ALSO READ – RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL
COATING AREA:
- General cleanliness of corridor
- General cleanliness of coating area
- Calibration status of gauges
- Labeling status of coating cubicles
- Status of batch record of the product being processed
- Temperature –humidity record
- Coating parameters as per BMR
- Identification of utility services
TABLET PACKING AREA:
- General cleanliness of corridor
- Arrangement of primary packaging materials
- Arrangement of secondary packaging materials
- Line clearance procedure
- Identification of utility services
- Labeling status
- Rubber stereo handling procedure and record
- Status of batch record of the product being packed
- Scrap disposal procedure