Standard Operating Procedure of Issue, Entry, Review & Control of Batch Manufacturing Records in Pharmaceuticals is describe in this post.
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1.0 OBJECTIVE:
To
lay down the procedure for issue,
entry, review, release and control of Batch Manufacturing Records by Q.A.
2.0 SCOPE:
This
SOP shall be applicable while issue,
entry, review, release and control of Batch Manufacturing Records.
3.0 RESPONSIBILITY:
3.1
Primary: Q.A.
Officer, Q.C. Officer, Production Officer.
3.2
Secondary: Q.A.
Manager, Q.C. Manager, Production Manager.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
4.2
Head of Production
Department.
5.0 PROCEDURE:
5.1
Issue
of batch manufacturing record (by Quality Assurance):
5.1.1
Based on
Production planning, production manager shall decide on the product and the
number of batches to be produced in the month.
5.1.2
Production
supervisor shall raise the requisition for the batches to be taken for the week
and forward it to Quality Assurance.
5.1.3
On receipt of
Batch Manufacturing Record issue requisition Q.A. personnel will verify the
details entered in the requisition form.
5.1.4
A photocopy of
the MASTER COPY of the required Product Batch Manufacturing Records will be
taken.
5.1.5
All the pages of
the photocopied sheet of Product Batch Manufacturing Record shall be signed and
dated by Q.A. personnel.
5.1.6
Check for the correctness of the Batch number
by verifying the BMR register.
5.1.7
Enter the
details of date, product, batch no., batch size, manufacturing date, expiry
date and issued by details in the BMR register.
5.1.8
Check and allot
expiry date by referring to master list of product shelf life.
5.1.9
If there is a
deviation for change in batch size or any other equipment/ process change raise
deviation approval form as per deviation procedure SOP.
5.1.10
Enter the batch
no. on all the pages of the BMR and get it authorized by Q.A. Manager or in
absence by Q.A. Executive or Q.A. Officer.
5.1.11
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.
5.1.12
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.
5.1.13
Q.A. person who
has issued Batch record shall sign the “issued by” on bath record issue
requisition sheet and file the same for future reference.
5.2
Entry
of batch manufacturing record (by Production Personnel):
5.2.1
On receipt of
BMR Production Manager/ Dy. Production Manager shall check the BMR and sign on
the first page.
5.2.2
The calculation
sheet should be forwarded to stores for entry of the relevant AR No.s, quantity
and assay value.
5.2.3
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.
5.2.4
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.
5.2.5
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.
5.2.6
After final
product obtained send the request to Q.C. for complete analysis of the product
and send the analytical report.
5.2.7
Fill all
remaining entry and attach all analytical report.
5.2.8
BMR should be
then send to Q.A. department for Review.
5.3
Review
and control of batch manufacturing record (by Quality Assurance):
5.3.1
Batch no. should
be checked by quality assurance department.
5.3.2
Review the
analytical report of all raw materials attached with BMR and checks the A.R.
No.
5.3.3
Review the
equipment cleaning record for each equipment and relevance of line clearance by
QC.
5.3.4
Review the deviation
in process which is predefined.
5.3.5
If any deviation
presents changes deviation report of process should be there. Review the report
of change in deviation and its significance in the process.
5.3.6
Check the
quantity of solvent recovered in the process. Recovery should be proper and
complete.
5.3.7
Wet material
packing record should be reviewed.
5.3.8
Drying record as
well as dry material packing record should be checked and reviewed.
5.3.9
Check the
analytical report of finished product generated by Q.C. department.
5.3.10
Finally attach
the review report with specific number given by Q.A. department duly dated and
signed by Q.A. Manager.
5.3.11
If everything is
fine then pass the batch and allow it for dispatch.
5.3.12
Send this record
in safe custody of Quality Assurance department.
5.3.13
If anybody needs
the copy of BMR it should be given as a control copy with permission of Q.A.
Manager.
5.3.14
Every BMR should
be saved for five years from manufacturing and after that it should be destroyed
as per SOP.