How to know about BPCR check list in Quality Assurance.
We are discussing about Batch Production Control Record check list.
The BPCR review should cover and typically requires the reviewer to initial each section that has been reviewed.
A specific check list should be prepared for each type of finished drug product because the manufacture of
tablets, capsules and oral liquids vary by process and parameters.
The important check points are mentioned here, those are
* Check for total number of pages.
* Check for batch numbers on all pages.
* Check for issued signature.
* Check whether all the columns are filled properly.
* Check for over writings.
* Check for QC reference numbers for all the raw materials.
* Check the dispencing labels ate attached and filled completely.
* Check all the parameters like temperature, pressure are recorded as per BPCR.
* Check all the in process samples sent to QC as per BPCR.
* Check the Yield column filled.
* Is there any Deviation related to this batch, wether the deviation is closed.
* Check all the Analytical reports with raw data notebook and other related documents.
The BPCR review should cover and typically requires the reviewer to initial each section that has been reviewed.
A specific check list should be prepared for each type of finished drug product because the manufacture of
tablets, capsules and oral liquids vary by process and parameters.
The important check points are mentioned here, those are
* Check for total number of pages.
* Check for batch numbers on all pages.
* Check for issued signature.
* Check whether all the columns are filled properly.
* Check for over writings.
* Check for QC reference numbers for all the raw materials.
* Check the dispencing labels ate attached and filled completely.
* Check all the parameters like temperature, pressure are recorded as per BPCR.
* Check all the in process samples sent to QC as per BPCR.
* Check the Yield column filled.
* Is there any Deviation related to this batch, wether the deviation is closed.
* Check all the Analytical reports with raw data notebook and other related documents.
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