Review of Batch Production Records -

Review of Batch Production RecordsOBJECTIVE :

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.
RESPONSIBILITY :
Quality Assurance Officer.
Head of Quality Assurance Department to ensure compliance.
PROCEDURE :
Officer – Quality Assurance shall :
Check all sections of the Batch production Record (BPR), for the accuracy and correctness of the information recorded.
Check that each operation is performed and recorded in full compliance with the issued Batch Production Record, and in accordance with approved procedures.
Verify entries made on documents of BPR by counter checking all the related Raw data for Accuracy.
Check the incidents/deviations (if any) for proper documentation, investigation of any non-conforming in-process events/out of specification results.
Check the correctness and completeness of the BPR as per the ‘Checklist for Quality Assurance review of BPR’ (annexure-1) and sign the same.
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.
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.
The Checklist for review of BPR shall be filed with the respective BPR.

Forms and Records (Annexures)
Specimen format of “Checklist for Quality Assurance review of BPR” – Annexure-1

Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History

Date

Revision Number

Reason for Revision

–

00

New SOP

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 of current Master Production Record	Yes / No
2	All the issued pages are available	Yes / No
3	‘Checked and Issued ‘ by columns at the top of each PO-RM, PO-PM are signed, dated by concerned personnel	Yes / No
4	Batch # mentioned correctly on all pages.	Yes / No
5	Adjustment of Quantity of Active ingredient as 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: All manufacturing instruction followed and accurately documented with respect to equipment 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 clearance checklist	Complete / Incomplete
21	BPR – Packaging Instructions: All packaging instruction steps filled out referencing equipment used, quantities Packed, Signed and dated.	Complete / Incomplete
22	Expiry date assigned correctly and mentioned in all packaging records.	Complete / Incomplete
23	Specimen of coded labeling and literature.	Complete / Incomplete
24	In-process checks during packing operation	Complete / Incomplete
25	Sample collection record	Complete / Incomplete
26	Labels and packaging material reconciliation record	Complete / Incomplete
27	Summary statement of Batch yield for Tablets /Capsules	Complete / Incomplete
28	Review of analytical records during blending.	Complete / Incomplete
29	Review of analytical records of core tablets / Coated tablets / Filled capsules.	Complete / Incomplete
30	Review of Finished product analytical records/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

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.

RESPONSIBILITY :

Quality Assurance Officer.

Head of Quality Assurance Department to ensure compliance.

PROCEDURE :

Officer – Quality Assurance shall :

Check all sections of the Batch production Record (BPR), for the accuracy and correctness of the information recorded.

Check that each operation is performed and recorded in full compliance with the issued Batch Production Record, and in accordance with approved procedures.

Verify entries made on documents of BPR by counter checking all the related Raw data for Accuracy.

Check the incidents/deviations (if any) for proper documentation, investigation of any non-conforming in-process events/out of specification results.

Check the correctness and completeness of the BPR as per the ‘Checklist for Quality Assurance review of BPR’ (annexure-1) and sign the same.

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.

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.

The Checklist for review of BPR shall be filed with the respective BPR.

Forms and Records (Annexures)

Specimen format of “Checklist for Quality Assurance review of BPR” – Annexure-1

Distribution

Master copy – Quality Assurance

Controlled copies- Quality Assurance, Production, Quality Control.engineering

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 of

current Master Production Record

Yes / No

2

All the issued pages are available

Yes / No

3

‘Checked and Issued ‘ by columns

at the top of each PO-RM, PO-PM are

signed, dated by concerned personnel

Yes / No

4

Batch # mentioned correctly on all pages.

Yes / No

5

Adjustment of Quantity of Active ingredient

as 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: All

manufacturing instruction followed and

accurately documented with respect to

equipment used, mixing, drying, loading and blending times, etc., with sign. and date.

Complete / Incomplete

13

Product labels, print outs of equipments