BMR Suspensions

WB/BMR/SUSP
Department Production Issue # 0

Section Suspension Issue Date 15 12 - 2 0 1 7
Revision Number 00 Next Revision Date 15 12 - 2 0 2 0
BATCH MANUFACTURING RECORD
Product Name: ____________________________ Batch No.
Batch Size: Mfg. Date: Expiry Date:
Pack Size: Commercial: Physician sample:
Production Manager Quality Control Manager:
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INSTRUCTIONS
1. The manufacturing processing must be carried out strictly according to this process sheet. Any deviation
from this process must be authorized by the Production and Quality Control management and will be
recorded in the Batch Manufacturing Record (BMR).
2. All operations from dispensing to tablet coating must be conducted at a relative humidity below 50% and
the temperature not exceeding 30oC. This should be properly recorded.
3. Before commencing the processing, check that all the batch material are available and bear the dispensing
tags indicating product name, M.O. #, B. #., Item, A. # and date.
4. The %age formula should be calculated on the basis of assay results of active ingredient(s).
5. Wash all equipments and flush out drains well after cleaning up residues of the previously manufactured
batches.
6. Rejected material (if any) should be disposed off by dissolving in sufficient water.
7. All in process and bulk (compression mix, tablets coated/uncoated) should be kept in humidity controlled
cool areas away from sunlight.
8. Ensure that the area and equipment are thoroughly cleaned and dried before use and cleaning status labels
duly signed by the manufacturing supervisor are attached where applicable.
9. Personnel working in the manufacturing area must wear the suitable protective clothing i.e., masks, gloves
and goggles when and where required.
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WB/BMR/SUSP
STEP 1: Pre – Production Checks
 Check Raw Materials is issued using FIFO procedure.

 All materials for previous job are removed.
 All Area and Line clearance certificates are granted according to the
procedures from Quality Control Department. Production Pharmacist.
Standard Quantity
Sr. # Ingredient Unit Initials
Quantity Received
Supplementary issue
Date
SUPPLIMENTRY ISSUE
Material Quantity
Material Name Unit Initial
Code Received
State Reason for Adjustment(s) (if any):
BATCH MANUFACTING PROCESS
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WB/BMR/SUSP
PRE - DISPENSING GMP CHECKS

Area cleaning and status checks
 Before starting dispensing ensure that:

 Dispensing area is clean & clear from the remains of previous product.
 Related documents of the product to be dispensed are properly filled and available.
 Quantities of the raw materials have been checked to be correct as per their potency against the
quantities of standard batch size.
 Raw materials to be dispensed have been approved by quality assurance department
 Air conditioning and exhaust system is working properly and temperature and relative humidity
must be below 50% and the dry temperature not exceeding 25C.
Labels on raw materials container from the store have been checked for correct material and lot No.
to be dispensed.
Production Officer Date
Equipment / Machine cleaning & status check
 Equipment / Machine (scales/weighing balances, scoops etc.) to be used for dispensing

are, clean and clear from the remains of previous product.
Previous Product: --------------------) Batch No. ------------------)

 The weighing balance / scale is calibrated and working properly. Plastic bags and containers
required for dispensing material are clean and labeled.
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WB/BMR/SUSP
Step 2. BATCH MATERIAL DISPENSING & RECEIVING
Operational Procedure
 Based on the Manufacturing order, received from the production department confirm the batch
size of the product and quantities referring to the standard formulation.
 Weighing must be carried out in the presence of a Qualified Pharmacist, Quality Assurance
Inspector and a Warehouse Officer.
 In calculating the quantities give specific attention to the batch size to be manufactured vis-à-vis
the standard batch size and the potency of the active material vis-à-vis standard quantity as per
formula based on 100% potency.
 Check the calibration record of weighing balance scale.
 On confirming the above detail start dispensing.
 Weigh the ingredients one by one.
 After weighing each item, put a dispensing tag on the plastic bag / container mentioning product
name, item name, and batch number etc.
 At the end of the process, the documents must be signed and filed by authorized Officer.
 Attach one copy of the Manufacturing Order form with Batch Manufacturing Record.
 After weighing is completed, bring the raw material to the manufacturing area and cross –check,
the weights of raw materials dispensed against the quantities calculated on the basis of their
potency and written in the manufacturing order form.
Warehouse Officer Production Officer
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WB/BMR/SUSP
Step 3. PRE – MANUFACTURING GMP CHECKS
Area cleaning and status checks

 Before starting manufacturing ensured that the manufacturing area is clean and cleared from the
remains of previous products.
 Storage containers are clean and cleared from the remains of previous product.
 No material other than specified in the Manufacturing order form is present in the manufacturing
area.
 Related documents of the product to be manufactured are available and the quantity of raw
material has been cross checked.
 Air conditioning and exhaust system is working properly and relative humidity must be below 50%
and the dry temperature not exceeding 25C.
LINE CLEARANCE CERTIFICATE FOR SIEVING
 Machine / Equipment cleaning and status checks

 All equipment required for sieving and lubrication are clean and cleared from the remains of
previous product and in case of product change over also performing the swab test.
PRODUCTION PHARMACIST
SWAB TEST RESULTS
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WB/BMR/SUSP
QAI
STEP 4 SIEVING: Operator Pharmacist
Sieve the following ingredient through 30 Mesh SS Screen.

Standard
Raw Material Unit Quantity Used
Quantity
Kgs.
Kgs.
Kgs.
Add the above ingredient into Double Cone Mixer and mix them.
Mixing Mixing Total Time

Start Time Stop Time Consumed
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WB/BMR/SUSP
STEP 5.Reprocess/Rework:
Record any deviation from the standard procedure or reprocessing and

reworking. This must be approved by Production and QA Managers.
Product: ____________________ B. No. ____________
Status: _____________________ Quantity: __________
Mfg. Date: __________________ Exp. Date: _________
Is to be reworked in
Product: ____________________ B. No. _____________
Status: _____________________ B. Size: ____________
Mfg. Date: __________________ Exp. Date: __________
Remarks: ______________________________________
______________________________________________
Prepared by: _________________ Approved by: _________

(PHARMACIST) (PRODUCTION MANAGER)
Authorized by: ____________

(QA/QC manager)
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WB/BMR/SUSP
LINE CLEARANCE
Before starting the lubrication/final mixing check that the mixer and scoops are clean.
Previous product batch number
Production pharmacist
Swab test results
Line clearance is granted for the mixing.
QAI
Pharmaci
STEP 6.1: POWDER YIELD Date Operator
st
After /lubrication get the final granules yield and inform quality control
department for sampling, according to the procedures.
% Line
Standard Actual
Losses
Quality
Pharmaci
STEP 6.2: Quality Control Clearance Date Assuranc
st
e Officer.
The release for FILLING is granted from the Quality Control dep’t.
According to the procedures.
STEP 7.LINE CLEARANCE
Before commencing the filling check that the filling and sealing machine, hardness tester ,
scoops and containers are clean and labeled with Batch No. and
Date. Perform the swab test, in case of product change over.
Previous product batch number
Swab test results
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WB/BMR/SUSP
Production pharmacist QAI
STEP 8.1: POWDER FILLING Date Operator Pharmacist

Adjust the Volume, of the dry powder in accordance with the
Certificate of Analysis (In process Product) issued by the Quality
Control Department and fill bottles on powder filling machine. Along
with cap sealing.
VOLUME ADJUSTED:
Filling Filling Total

Start Time/Date Stop Time/Date
Time Consumed
STEP 9. INPROCESS CONTROL SHEET Filling (weight variation)
Date Time 1 2 3 4 5 Average Wt Production QA/QC
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STEP 10. FILLED BOTTLES SORTING/CLEANING.
Sort Out Bottles With Damaged/Broken Seals
Date Performed by Checked by Remarks
BOTTLES
SORTING
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Performed by Checked by
STEP11: Packaging
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11.1 RECEIVING PACKAGING MATERIAL:
Receive all the packaging components from packaging material store and check their quantity.
Received by: _______________ Checked by: ______________
11.2 PRINTING OF CARTONS:
Give cartons for printing of Batch No., Manufacturing Date and Expiry Date to printing section.
Date Performed by Checked by Remarks
Printing
Production pharmacist Q.A OFFICER
Previous Product:
Clearance Granted
Batch No.:
Ensure that there should not be any remnants Production Officer Time Date
of the previous batch.
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Checked by Belt Incharge: Quality Assurance Time Date
Inspector
Production Officer:
12. FINAL MASTER CARTON PACKING

Online Inspection
Date Time Over General Appearance Sealing Leaflet Pack QAI P.O
Printing Carton Blister Size
STEP13: Batch Reconciliation
Practical Yield. No. of packs %age. %age.

Theoretical Yield. FGS Q/C Total produced. Yield. Loss.
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Comm. /Packs.
P/S Packs.
PHARMACIST:
REMARKS IF ANY.
After packaging inform quality control department for sampling, according to the procedures for
request for analysis.
Production Manager. Quality Control Manager.
Finished Product Transfer Slip
Product Name: __________________ Batch #._____________
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Date Time Pack size Qty. Transferred Total Qty Status Issued By Recvd By
No.of M/C Loose Pack Transferred
Till Date
Batch Size:_______________ Mfg Date :___________ Exp Date:___________
Total Quantity transferred on Completion of Batch:____________________
Pack Size:_______________ _____________________________
Sample to Q.C __________ ______________________________
Total Batch Qty:__________________ ______________________________
______________________ _______________________ ____________________
Warehouse Incharge Production Manager QA/Q.C Manager
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WB/BMR/SUSP

Department Production Issue # 0

BATCH MANUFACTURING RECORD

Product Name: ____________________________ Batch No.

Batch Size: Mfg. Date: Expiry Date:

Pack Size: Commercial: Physician sample:

Production Manager Quality Control Manager:

 Check Raw Materials is issued using FIFO procedure.

State Reason for Adjustment(s) (if any):

BATCH MANUFACTING PROCESS

PRE - DISPENSING GMP CHECKS

 Before starting dispensing ensure that:

Production Officer Date

Equipment / Machine cleaning & status check

 Equipment / Machine (scales/weighing balances, scoops etc.) to be used for dispensing

Previous Product: --------------------) Batch No. ------------------)

Production Officer Date

Step 2. BATCH MATERIAL DISPENSING & RECEIVING

 Check the calibration record of weighing balance scale.

 On confirming the above detail start dispensing.

 Weigh the ingredients one by one.

Warehouse Officer Production Officer

Step 3. PRE – MANUFACTURING GMP CHECKS

Area cleaning and status checks

Production Officer Date

LINE CLEARANCE CERTIFICATE FOR SIEVING

 Machine / Equipment cleaning and status checks

SWAB TEST RESULTS

STEP 4 SIEVING: Operator Pharmacist

Sieve the following ingredient through 30 Mesh SS Screen.

Mixing Mixing Total Time

Record any deviation from the standard procedure or reprocessing and

Product: ____________________ B. No. ____________

Status: _____________________ Quantity: __________

Mfg. Date: __________________ Exp. Date: _________

Product: ____________________ B. No. _____________

Status: _____________________ B. Size: ____________

Mfg. Date: __________________ Exp. Date: __________

Prepared by: _________________ Approved by: _________

Authorized by: ____________

Previous product batch number

Swab test results

Line clearance is granted for the mixing.

STEP 7.LINE CLEARANCE

Previous product batch number

Swab test results

Production pharmacist QAI

STEP 8.1: POWDER FILLING Date Operator Pharmacist

Filling Filling Total

STEP 9. INPROCESS CONTROL SHEET Filling (weight variation)

Date Time 1 2 3 4 5 Average Wt Production QA/QC

STEP 10. FILLED BOTTLES SORTING/CLEANING.

Sort Out Bottles With Damaged/Broken Seals

Date Performed by Checked by Remarks

Received by: _______________ Checked by: ______________

Product: ________ B. No.

Status: ___________ Quantity:

Mfg. Date: __________ Exp. Date: _

Product: ________ B. No. _

Status: _________ B. Size:

Mfg. Date: ________ Exp. Date:

Prepared by: _________ Approved by: _

Received by: _ Checked by:

Product Name: ______ Batch #._

Batch Size:_________ Mfg Date :_ Exp Date:_______

Pack Size:_ _______________

Sample to Q.C ____________________

Total Batch Qty: ____________

__________ _ __________