1.0 Purpose
1.1 To define a standardized procedure for the issuance of Batch Manufacturing Record (BMR) and
Batch Packaging Record (BPR) of a product.
2.0 Scope
2.1 This procedure applies for all batches
of finished products manufactured by NAME Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Quality
Assurance Personnel is responsible to issue BMR & BPR.
4.0 Abbreviations and Definitions
4.1
BMR
: Batch Manufacturing Records
4.2 BPR
: Batch
Packaging Records
5.0 Materials and Equipment
5.1 None
6.0 Precaution / Health and Safety Considerations
6.1
None
7.0 Procedure
7.1 Production Department sends a written request through “Batch Initiation Form” (Annexure-I) to Quality Assurance
for issuing the Batch Manufacturing Record (BMR) & Batch Packaging Record (BPR) in advance (minimum 4 hrs.
before necessary) .
7.2 Quality Assurance Department send the “Batch Initiation Form” to Warehouse for check the availability of raw
and packaging materials.
7.3 Ensure the availability of raw and packaging materials; Quality Assurance officer will make a set of
complete photocopies of the required BMR and BPR.
7.4 Photocopying of the Master BMR or BPR shall be done under supervision of an authorized person from
QA Department.
7.5 A batch number shall be assigned and entered into the ‘BMR/BPR Issuance Log’ (Annexure-II) and the same
number to be entered each page of the BMR.
7.6 For assignment of batch numbers follow SOP for “Batch Numbering System”.
7.7 The same batch number and Mfg. and Exp. Date shall be assigned and entered into each page of the BPR.
7.8 The Issued By section of the BMR/BPR shall be signed by Quality Assurance Personnel.
7.9 Send the BMR and BPR to Production Department and Production Officer shall receive the documents by
signing the ‘BMR/BPR Issuance Log.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Annexure-I : Batch Initiation Form
9.2 Annexure-II : Format of “BMR/BPR Issuance Log”
10.0 Revision History
|
Version No. |
Brief Reason for the Revision |
Effective Date |
Remarks |
|
01. |
New |
|
|
|
|
|
|
|
11.0 Training
11.1
Training is required for Executives of QA departments trained by Head of
Quality Assurance
Annexure-I
|
Batch
Initiation Form (BIF) |
From: Production Department To: QA Department
|
Product
Name |
|
Date
of Requisition |
|
|
No.
of batch(s) intended to manufacture |
|
Standard
Batch Size |
|
|
Commercial
Pack Qty. |
|
Physician’s
Sample Qty. (1’s/2’s/4’s C.C) |
|
|
Requisition
Raised by |
___________________ Signature & Date (Production) |
Requisition
Received By |
____________________ Signature & Date (Quality Assurance) |
From: QA Department To: Warehouse
|
Dear, Please
check the availability of all raw & packing materials for the above batch
manufacturing
_____________ Signature & Date (Quality Assurance) |
From: Warehouse To: QA Department
|
Raw
Material Status |
Packing Material Status |
||
|
|
|
||
|
Checked by |
_______________________ Signature & Date (Warehouse) |
Checked by |
_______________________ Signature & Date (Warehouse) |
|
QA Recommendation:
( ) BMR & BPR Issue / ( ) Not
Issue BMR & BPR
|
