SELF INSPECTION CHECKLIST FOR CAPSULE
CHANGE ROOM:
- General cleanliness
- Entry /Exit procedure
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
- Cleaning of Filter
ALSO READ – RISK ASSESSMENT PROTOCOL FOR DEPYROGENATION TUNNEL
GRANULES – QUARANTINE AREA:
- General cleanliness
- Labeling status on containers
- Balance calibration status
CAPSULE FILLING AREA:
- Equipment status
- Labeling status of area/ containers
- Use of protective equipment’s (e.g. Hand gloves, nose masks etc.) in the filling area?
- Identification of utility services
- Filling machine – Equipment sequential log is maintained
CAPSULE 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