Checklist for BMR


 All the materials taken for production are approved.
 All the quality raw materials used for Blending/Sieving/Milling are weighed and recorded correctly.
 All the materials have been taken as per the standard quantity
 Is the Quantity of active ingredients taken for batch calculated correctly?
Line clearance taken before dispensing and counter checked by IPQA properly.
 Temperature is within the limit in the dispensing room.
 Are correct sieves used for sieving the materials as per the batch record?
 The Blending duration and blending quantities are recorded as per the batch record.
 All signatures and dates are filled properly in all columns.
 Does the compression/filling started after the approval of blend by QC
 Blend report is approved and attached in BMR.
 Is line clearance is taken before compression/filling.
 Compression/filling parameters are set as per the limits specified in BMR.
 Are the in-process checks are performed at the frequency and recorded properly, and counter-checked by IPQA?
 In-process parameters are within limits.
 Temperature and Humidity in the compression/filling area are as per the limits.
 The QC report after compression/filling attached to BMR.
 Is the coating started after the QC approval of compression?
 Machine setting parameters for coating are as per the limits specified in BMR.
 Are the visual checking parameters are recorded properly?
 Overall signatures are filled correctly in the specified columns
 The yield at all stages is within the limits as specified in BMR.
 QC report after the coating is approved and attached to BMR.

In case of any discrepancy in the above points, fill BPRR/BPAR deviations /deficiencies form and verify the corrections made.

Share This Post

Related Articles

© 2024 Pharmaceuticals Index. All rights reserved.