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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

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

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