Quality Assurance person shall ensure the following Checklist For BMR Release:
The header section of the checklist must contain Product brand name, Product Generic name, Batch Number, Batch size, BMR number, and QA release number.
A Checklist for BMR
1.1 All the materials taken for production are approved.
1.2 All the quality raw materials used for Blending/Sieving/Milling are weighed and recorded correctly.
1.3 All the materials have been taken as per the standard quantity
1.4 Is the Quantity of active ingredients taken for batch calculated correctly.
1.5 Line clearance taken before dispensing and counter checked by IPQA properly.
1.6 Temperature is within the limit in the dispensing room.
1.7 Are correct sieves used for sieving the materials as per the batch record.
1.8 The Blending duration and blending quantities are recorded as per the batch record.
1.9 All signatures and dates are filled properly in all columns.
2.0 Does the compression/filling started after the approval of blend by QC
2.1 Blend report is approved and attached in BMR.
2.2 Is line clearance is taken before compression/filling.
2.3 Compression/filling parameters are set as per the limits specified in BMR.
2.4 Are the in-process checks are performed at the frequency and recorded properly, and counter-checked by IPQA.
2.5 In-process parameters are within limits.
2.6 Temperature and Humidity in the compression/filling area are as per the limits.
2.7 The QC report after compression/filling attached to BMR.
2.8 Is the coating started after the QC approval of compression.
2.9 Machine setting parameters for coating are as per the limits specified in BMR.
2.10 Are the visual checking parameters are recorded properly.
2.11 Overall signatures are filled correctly in the specified columns
2.12 The yield at all stages is within the limits as specified in BMR.
2.13 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.
- The Footer section for the Checklist for BMR must be checked by and approved by with sign and current date.