bmr (batch manufacturing record)

Facilitators: -Dr. Vishal Kumar Gupta,Asst Professor,Dept. of Pharmaceutics,JSS college of pharmacy,Mysore.

Submitted by: -

Ram Mohan S.R.

1st M.Pharm

Pharmaceutical Quality Assurance

JSS college of pharmacy

Mysore

1

Batch manufacturing records should be prepared for

each intermediate and API/formulation and should

include complete information relating to the

manufacturing and control of each batch.

The batch manufacturing record should be checked

before issuance to assure that it is the correct version

and a legible accurate reproduction of the appropriate

master production instruction.

Pharmaceutical Quality Assurance, Dept of Pharmaceutics 2

Before any processing begins, a check should be

performed and recorded to ensure that the equipment

and workstation are clear of previous products,

documents, or materials not required for the planned

process and that the equipment is clean and suitable

for use.

These records should be numbered with a unique

batch or identification number and dated and signed

when issued.


Contd……

The “Batch Manufacturing Record” is the necessary quality and GMP documentation for tracing the complete cycle of manufacturing batch or lot

4Pharmaceutical Quality Assurance, Dept of Pharmaceutics

Documentation of completion of each

significant step in the BMR should include:

• Dates and, when appropriate, times

• Identity of major equipment used (e.g., reactors,

driers, mills, etc.)

• Actual results recorded for critical process

parameters

• Any sampling performed


• Specific identification of each batch, including weights,

measures, and batch numbers of raw materials,

intermediates, or any reprocessed materials used during

manufacturing

• Signatures of the persons performing and directly

supervising or checking each critical step in the

operation

• In-process and laboratory test results

• Actual yield at appropriate phases or times


• Description of packaging and label

• Representative label (commercial supply)

• Any deviation noted, its evaluation, and investigation

conducted (if appropriate) or reference to that

investigation (if stored separately).

• A decision for the release or rejection of the batch, with

the date and signature of the person responsible for the

decision.

• Results of release testing


• Production and quality control records should be

reviewed as part of the approval process of batch

release.

• Any divergence or failure of a batch to meet its

specifications should be thoroughly investigated.

• The investigation should, if necessary, extend to

other batches of the same product and other products

that may have been associated with the specific

failure or discrepancy.


Responsibility :-

Primary: Officer–QA / Officer–QC/ Officer-Production

Secondary: Manager-QA/ Manager- QC/ Manager- Production


Issue of batch manufacturing record

( by Quality Assurance)

1) Based on Production planning, production manager

shall decide on the product and the number of batches

to be produced in the month.

2) Production supervisor shall raise the requisition for the

batches to be taken for the week and forward it to

Quality Assurance.Pharmaceutical Quality Assurance, Dept of Pharmaceutics 10

3) On receipt of Batch Manufacturing Record issue

requisition QA personnel will verify the details

entered in the requisition form.

4) A photocopy of the MASTER COPY of the

required Product Batch Manufacturing Record

will be taken.

5) All the pages of the photocopied sheet of Product

Batch Manufacturing Record shall be signed and

dated by QA Personnel.


6) Check for the correctness of the Batch number by

verifying the BMR register.

7) Enter the details of Date, Product, Batch No, Batch

size, Manufacturing Date, Expiry Date and issued

by details in the BMR register.

8) Check and allot expiry date by referring to master

list of product shelf life.


9) Enter the batch no. On all the pages of the BMR and get

it authorized by QA manager or in absence by QA

executive or QA officer.

10) Insert the signed batch record in a BMR cover and enter

the details of product name, batch number, batch size.

Manufacturing date and expiry date.

11) Batch record along with the batch record register shall be

sent to production, the production person receiving the

batch record should sign on the batch record register to

acknowledge the receipt of batch record.

12) QA person who has issued Batch Record shall sign the

“issued by” on batch record issue requisition sheet and file the

same for future reference.


Entry of Batch Manufacturing Records

(By Production Personnel)

1) On receipt of BMR Production Manager/Dy.

production Manager shall check the BMR and sign on

the first page.

2) The calculation sheet should be forwarded to stores for

entry of the relevant AR Nos., quantity and assay

value.


3) After the relevant entry store forward the sheet to

production department where production chemist

fill equipment status detail where line clearance

status and ECR No. should be entered for each

equipment.

4) Now operator fill the next form of process to be

carried out for particular reactor in which starting

and ending time should be entered and finally sign

by operator and checked by in-charge.


5) After completion of every reaction in each of the

particular reactor intermediate should be send to QC

Lab. for checking of completion of reaction, LOD etc.

6) After final product obtained send the request to QC

for complete analysis of the product and send the

analytical report.

7) Fill all remaining entry and attach all analytical report.

8) BMR should be then send to QA department for Review


Review and Control of Batch Manufacturing

Records

( by Quality Assurance)

1) Batch No. should be checked by Quality assurance

department.

2) Review the Analytical report of all raw materials

attached with BMR and check the A.R. No.

3) Review the Equipment Cleaning Record for each

equipment and relevance of line clearance by QC.Pharmaceutical Quality Assurance, Dept of Pharmaceutics 17

4) Review the deviation in process which is

predefined.

5) If any deviation present change deviation report of

process should be there. Review the report of

change in deviation and its significance in the

process.

6) Check the quantity of solvent recovered in the

process. Recovery should be proper and complete.

7) Wet material packing record should be reviewed.


8) Drying record as well as dry material packing record

should be checked and reviewed.

9) Check the analytical report of finished product

generated by QC department.

10) Finally attach the review report with specific

number given by QA department duly dated and

singed by QA manager.

11) If everything is fine then pass the batch and allow it for dispatch


12) Send this record in safe custody of Quality

Assurance department.

13) If anybody needs the copy of BMR it should be

given as a control copy with permission of QA

Manager.

14) Every BMR should be saved for five years from

manufacturing and after that it should be destroyed

as per SOP.


Batch Manufacturing Record

Attachments

Responsibility :

Primary : Production Chemist.

Secondary : Production Officer.


Following attachments required to be attached to Batch

Manufacturing Record before submitting the completed

BMR to Quality Assurance.

• Equipment clean record status label.

• Equipment clean record.

• Raw materials dispensed weighing slip.

• Intermediate raw material sealed.


• Transfer note for finished goods to F.G. store.

• Raw material issue order (P.R).

• IPQC- In Process Test Request Cum Report.

• Excess material requisition (S.R.).

• Deviation note if any.

• Certificate Of Analysis (COA).

• Finish product dispatch data.


BMR draft


bmr-final.pdf


D.H. SHAH, “QA Manual”,1/e,S/p 2010,

Business Horizons, page no 174-176

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bmr (batch manufacturing record)

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