Review of Batch Production RecordsOBJECTIVE :
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To provide a procedure for the review of Batch production Record (BPR) before release of drug products, in order to verify the compliance with cGMP requirements and all established specifications and written procedures in the manufacturing of the product batch.
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RESPONSIBILITY :
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Quality Assurance Officer.
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Head of Quality Assurance Department to ensure compliance.
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PROCEDURE :
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Officer – Quality Assurance shall :
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Check all sections of the Batch production Record (BPR), for the accuracy and correctness of the information recorded.
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Check that each operation is performed and recorded in full compliance with the issued Batch Production Record, and in accordance with approved procedures.
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Verify entries made on documents of BPR by counter checking all the related Raw data for Accuracy.
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Check the incidents/deviations (if any) for proper documentation, investigation of any non-conforming in-process events/out of specification results.
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Check the correctness and completeness of the BPR as per the ‘Checklist for Quality Assurance review of BPR’ (annexure-1) and sign the same.
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In the event of absence of specific document(s) or incorrect and incomplete entries made on any document, or incomplete investigation reports of deviations shall be notified to the personnel responsible and the Head of Production department for appropriate action.
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After the BPR is found to be complete and satisfactory in all respects, Officer – QA shall sign with date on each page of the BPR.
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The Checklist for review of BPR shall be filed with the respective BPR.
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Forms and Records (Annexures)
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Specimen format of “Checklist for Quality Assurance review of BPR” – Annexure-1
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Distribution
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Master copy – Quality Assurance
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Controlled copies- Quality Assurance, Production, Quality Control.engineering
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History
Date
Revision Number
Reason for Revision
–
00
New SOP
Annexure-1
CHECK LIST FOR QUALITY ASSURANCE REVIEW OF BPR
Product Name: |
|||
Batch No. : |
Batch size: |
||
S.No. |
Item to be checked |
Inference of QA Officer |
Remarks |
1 |
BPR is an accurate reproduction ofcurrent Master Production Record |
Yes / No |
|
2 |
All the issued pages are available |
Yes / No |
|
3 |
‘Checked and Issued ‘ by columnsat the top of each PO-RM, PO-PM aresigned, dated by concerned personnel |
Yes / No |
|
4 |
Batch # mentioned correctly on all pages. |
Yes / No |
|
5 |
Adjustment of Quantity of Active ingredientas per instruction. |
Complete / Incomplete |
|
6 |
Production order raw material |
Complete / Incomplete |
|
7 |
Weighing Record of raw materials |
Complete / Incomplete |
|
8 |
Material details labels |
Complete / Incomplete |
|
9 |
Area cleaning and clearance check list |
Complete / Incomplete |
|
10 |
‘Equipment Cleaned Type A/B/C” labels |
Complete / Incomplete |
|
11 |
Equipment Clearance check lists. |
Complete / Incomplete |
|
12 |
BPR Manufacturing Instructions: Allmanufacturing instruction followed andaccurately documented with respect toequipment used, mixing, drying, loading and blending times, etc., with sign. and date. |
Complete / Incomplete |
|
13 |
Product labels, print outs of equipments(if applicable) |
Complete / Incomplete |
|
14 |
Environmental conditions are within the limit |
Complete / Incomplete |
|
15 |
In-Process check records during tablet compression/ capsule filling. |
Complete / Incomplete |
|
16 |
In process check records during coating |
Complete / Incomplete |
|
17 |
Stage wise yield and reconciliation |
Complete / Incomplete |
|
18 |
Production order packaging material |
Complete / Incomplete |
|
19 |
Packaging material weighing record |
Complete / Incomplete |
|
20 |
Packaging area cleaning and clearancechecklist |
Complete / Incomplete |
|
21 |
BPR – Packaging Instructions: Allpackaging instruction steps filled outreferencing equipment used, quantitiesPacked, Signed and dated. |
Complete / Incomplete |
|
22 |
Expiry date assigned correctly andmentioned in all packaging records. |
Complete / Incomplete |
|
23 |
Specimen of coded labeling andliterature. |
Complete / Incomplete |
|
24 |
In-process checks during packingoperation |
Complete / Incomplete |
|
25 |
Sample collection record |
Complete / Incomplete |
|
26 |
Labels and packaging materialreconciliation record |
Complete / Incomplete |
|
27 |
Summary statement of Batch yield forTablets /Capsules |
Complete / Incomplete |
|
28 |
Review of analytical records duringblending. |
Complete / Incomplete |
|
29 |
Review of analytical records of coretablets / Coated tablets / Filled capsules. |
Complete / Incomplete |
|
30 |
Review of Finished product analyticalrecords/other analytical records if any. |
Complete / Incomplete |
|
31 |
Finish product release report |
Complete / Incomplete |
|
32 |
Any deviations/Incidents are appropriately documented, investigated and disposed. |
Complete / Incomplete |