IPQA check points during line clearance
In Process-quality assurance personnel is responsible for giving the line clearance during the beginning of the manufacturing process. Line clearance activity looks easy, but it’s a task that must be executed with care as several checkpoints must be gone thoroughly, as they affect the quality of the product being manufactured.
Checkpoints during line clearance
- Area status should be updated for cleaned state
- Gowning area should be cleaned state
- Waste and reject bins should be cleaned
- Equipment cleaning should be checked, and logbooks should be verified.
- Processing area cleaning should be verified
- All the in-process instruments should be checked for cleaning and their calibration status
- Cleaning and sanitization of drains should be checked
- Check whether the return riser filters are replaced with new ones if it is type-b cleaning
- Ensure all the executed checklists are properly filled and no documentation errors
- Check the previous stage for completeness, before proceeding for the next stage
- Ensure no open breakdowns are present, before proceeding for line Clearance
- Ensure temperature and RH are within the limits
- Ensure differential pressure is within the limits
- Ensure rinse and swab sample if done, results are within in the limits
- No previous products residues are present in the cleaned area
- Check the preventive Maintenace status of the equipment
- Ensure the cleaning of ceiling, light fixtures, walls, doors and utility manifolds.
- Ensure batch records of previous batches are removed.
There are several other points are that might be present, which depends on the procedures set by the company, The above points are for reference only , to get idea.