Checking When Problems Occur

In the precaution steps, if the problem requires more than 24 hr to resolve, what action we need to do?

• Transfer bulk to WIP

• Inform immediate superior

• Continue environment monitoring

• Do nothing

When problems occur, what should we do first?

• Inform immediate superior

• Stop machine operation

• Do nothing

• Raised deviation

Where should we record the problem description?

• Room activity logbook

• Machine/Equipment Logbook

• IPC form

• ROI form

Which are the steps taken when problems regarding wrong labelling or coding occur?

• Stop the process

• 100% visual checking

• Identify the root cause

• Reject the wrong coded label

• Request additional and set up equipment accordingly

What are the Critical Quality Attribute affected by Hopper design for the compression machine?

• Assay

• Content Uniformity

• Weight variation

• Moisture content