BIOLIFE MEDICAL PVT LTD

D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

BLOOD BAG WITH ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION AS
Product Name PER IP AND RED BLOOD CELL PRESERVATIVE SOLUTION (SAG-M)
Product Code Total Units
Batch Number Batch Size
Mfg. Exp.
Type

1.0 STAGE: EMPTY BAG MAKING

Batch No.-__________
Date of Manufacturing : _____________
Required Qty.in Batch : Balance Qty: __________

2.0 ASSEMBLY OF TUBES IN EMPTY MOTHER BAG AND TRANSFER BAGS.

Date of activity:__________
Process Start time: ________ Process End Time: _______
A) Environmental Conditions:
Temperature- 23±2 0 C Relative Humidity –50- 55% Positive Pressure-1.5 mmWG
(BAG Welding Area with respect to Airlock)
Observation:
Temperature: Relative Humidity: Positive Pressure:
B) Line Clearance
Perform the line clearance as per SOP No……. by ensuring the following points:

S. Activities Performed By/date Checked By/date Checked By/date

No. Production Production (QA)

1. Ensure all the leftovers of previous

batch are removed from the area
Ensure that all the rejections of the
2 previous batch removed from the
area and machine

Ensure that documents of previous

3. batch have been removed from the
line

4. Ensure the cleaning of the working

table.
Ensure that not any other materials
5. are kept in the area except relevant
batch.
Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 1 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

BLOOD BAG WITH ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION AS
Product Name PER IP AND RED BLOOD CELL PRESERVATIVE SOLUTION (SAG-M)
Product Code Total Units
Batch Number Batch Size
Mfg. Exp.
Type

C) Cut PVC tube pieces as per required length and assemble with Mother Bag and Transfer Bag as per
drawing and sequence mentioned in SOP No BL-PR-021.

Checked By/Date:__________ Approved By/Date:_____________

3.0 STAGE: LABEL PRINTING

Date of activity-__________
Process Start time________________ Process End Time_____________
(A) Environmental Conditions:
Limit:
Temperature- 23±2 0 C Relative Humidity -50- 55% Positive Pressure-1.5 mmWG
(BAG Welding Area with respect to Airlock)
Observation:
Temperature: Relative Humidity: Positive Pressure:

(B) Line Clearance

Perform the line clearance as per SOP no……. by ensuring the following points:

S. Activities Performed By/date Checked By/date Checked By/date

No. Production Production (QA)

1. Ensure all the leftovers of previous

batch are removed from the area

2 Ensure that all the rejections of the

previous batch removed from the

3. Ensure that documents of previous

batch have been removed from the

4. Ensure the cleaning of the

equipment.

5. Ensure that not any other materials

are kept in the area except relevant

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 2 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

(C) Equipment Name and ID:

(D) Printing: Perform the label printing of blood bags and check the label for visual checking.
Batch Information to be printed as given below:

Lot Number
Mfg. Date
Exp. Date
Code No.
Type
MRP
Other Information as per approved
artwork

(E) Visual Inspection of Printing

Total Qty. Received: ________________,________________,________________,

Parameters Label Rejected

Type Main (CPD) SAG-M Transfer Transfer
In-correct Batch information
Inclined printing
Spot/particles
Hole
Others
Total

Printed By/Date: _____________ Checked By/Date:________________

(F) Reconciliation of labels:

OK label
Qty. QC Rejected OK
Control transferred to Reconciliation
Type Recd. Sample Labels Balance
No. Next stage D+E/A *100
‘A’ ‘B’ ‘C’ E
‘D’ =A-(B+C)
Main
TOTM
SAG-M
Transfer

Performed By/Date: ______________________ Checked By/Date:__________________

Attach Specimen Sample

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 3 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

4.0 STAGE: SOLUTION PREPARATION

(Mixing of Chemical raw Materials)

Date of Activity:__________
Process Start time________________ Process End Time_______________

(A) Environmental Conditions:

Limit:
Temperature- 23± 2 0 C Relative Humidity –50-55 Positive Pressure- NLT 1.5 mmWG (with
respect to corridor)
Observation:
Temperature- Relative Humidity- Positive Pressure:
(B) Line Clearance
 Perform the line clearance as per SOP No…..by ensuring the following points:
S. Activities Performed Checked By/date Checked By
No. By(Production) (Production) (QA)

Ensure that the tank & other related

1.
accessories are cleaned & sanitised.

Ensure the cleaning of the mixing room

2.
area as per SOP No.

Ensure that documents of previous batch

3.
have been removed from the line

Ensure that no chemical of another batch is

4.
kept in the area.

(C) Check name, content & weight of all chemical raw materials carefully & record in the following
table:

LIST OF MATERIAL (CPD Solution)

Control Checked Verified
Materials Qty. Required Qty. Used By By
Number
Dextrose Anhydrous IP

Citric Acid (Anhydrous)

Sodium Dihydrogen Phosphate
(Dihydrate)
Sodium Citrate (Dihydrate)
Water For Injection

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 4 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

LIST OF MATERIAL (SAG-M Solution)

Control Checked Verified
Materials Qty. Required Qty. Used By By
Number
Sodium Chloride IP

Mannitol (Anhydrous) IP
Dextrose Anhydrous IP

Adenine (Anhydrous) IP
Water For Injection IP

(E) Mixing Process Detail of CPD

Tank ID No._______________________
Temperature of WFI:_____________
WFI QC No . :

S. No. Mixing detail Time Done Checked

by/date by/ date

1. Collect the WFI in the mixing tank upto From:......to........

half batch size level and mix,
1. Add Citric Acid IP and mix. From:......to.........

2. Add Sodium Citrate(Dihydrate) IP and From:.......to........

mix.

3. Sodium Dihydrogen Phosphate From:.......to.........

(Dihydrate) IP and mix.

4. Dextrose IP and mix. From:.......to.......

5. Make the final volume From:........to........

upto ..............Litre

6. Mix. the bulk solution for validated time From:.......to......

and submit the sample to QC for bulk
testing

Mixing Process Detail of SAG-M

Tank ID No._______________________
Temperature of WFI:_____________
WFI QC No . :

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 5 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

S. No. Mixing detail Time Done Checked

by/date by/ date

1. Collect the WFI in the mixing tank upto From:......to........

half batch size level and mix,
1. Add Sodium Chloride IP and mix. From:......to.........

2. Add Mannitol IP and mix. From:.......to........

3. Dextrose IP and mix. From:.......to.........

4. Adenine IP and mix. From:.......to.......

5. Make the final volume From:........to........

upto ..............Litre

6. Mix. the bulk solution for validated time From:.......to......

and submit the sample to QC for bulk
testing

(F) After completion of mixing draw the bulk sample & send to QC for chemical analysis along with
the following intimation slip.

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 6 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
SOLUTION INTIMATION SLIP
CPD Solution IP
Date:

To,
Quality Control Department.

Kindly analyze the enclosed bulk solution of the following batch and submit result to the undersigned-

Name of Product:_____________________ Sampling Time:______________________

Batch No.:___________________________ Sampled By:_______________________

Batch Size:___________________________ Sample Qty.:_________________________

____________________
Signature/Date
(Manufacturing Chemist)

QUALITY CONTROL RESULTS

Description Limits (g/100ml) Results

pH 5 -6
Dextrose (Monohydrate) IP 2.423 - 2.678 g
Sodium Citrate(Dihydrate) IP 2.4980 – 2.7610 g
Citric Acid (Monohydrate) 0.3106 – 0.3433 g
Sodium Dihydrogen Phosphate
(Dihydrate) IP 0.2384 – 0.2635 g

Result: The bulk solution has been tested as per SOP No________________&
complies/does not comply with the prescribed standard of quality.
Released Time:______________________

_____________________________ ________________________________
Signature/Date Signature/Date
(Analytical Chemist) (Manager Quality)

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 7 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

SOLUTION INTIMATION SLIP

SAG-M Solution IP
Date:

To,
Quality Control Department.

Kindly analyze the enclosed bulk solution of the following batch and submit result to the undersigned-

Name of Product:_____________________ Sampling Time:______________________

Batch No.:___________________________ Sampled By:_______________________

Batch Size:___________________________ Sample Qty.:_________________________

____________________
Signature/Date
(Manufacturing Chemist)

QUALITY CONTROL RESULTS

Description Limits (g/100ml) Results

pH 4.0 – 6.5

Sodium Chloride IP 0.8331 – 0.9208 g

Mannitol IP 0.4987 – 0.5512 g

Dextrose (Monohydrate) IP 0.855 – 0.945 g

Adenine (Anhydrous) IP 0.01605 – 0.01774 g

Result: The bulk solution has been tested as per SOP No________________&
complies/does not comply with the prescribed standard of quality.
Released Time:______________________

_____________________________ ________________________________
Signature/Date Signature/Date
(Analytical Chemist) (Manager Quality)

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 8 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

4.0 STAGE:FILLING
Date of Activity: _________________
Process Start time ( CPD)________________ Process End Time (CPD)_________________
Process Start time ( SAG-M)______________ Process End Time (SAG-M)_________________

(A) Environmental Conditions:

Limit:
Temperature- 23± 2 0 C Relative Humidity –50- 55 % Positive Pressure- NLT 0.7 mmWG (with
respect to corridor)
Observation:
Temperature- Relative Humidity- Positive Pressure:
(B) Laminar Air Flow
Operate the LAF as per SOP No.
(C) Intended Volume of each Bag: CPD ___________SAG-M ___________
(D) Filtration:
a) Pore Size of filters:
Prefilter---------------- Final Filter------------------
b) Integrity Test of filters:
Prefilteration Integrity Performed By/Date:................ Result: OK /NOT OK
Postfilteration Integrity Performed By/Date:................ Result: OK /NOT OK
(E) Line Clearance
Perform the line clearance as per SOP No….. by ensuring the following points:

S. Activities Performed By/date Checked By/date Checked

No. Production Production By/date (QA)

1. Ensure that all the leftovers of previous

batch are removed from the area machine.
Ensure that documents of previous batch
2. have been removed from the line

Ensure cleaning of the LAF & filling room

3. area

Ensure that no any other materials are kept

4. in the area except relevant batch.

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 9 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

LIST OF MATERIALS
Checked Verified
Materials Control Number Qty. Required Qty. Used By(QA)
By
Assembled blood
bags
Assembled needles

(F) Procedure
I Check that the filters, syringes & accessories are sterilized as per SOP.
II Set up the filling machine & start the activity of Filling as per SOP

IN-PROCESS INSPECTION OF FILLING OPERATION

 At every hour operator must check 2 bags from each nozzle for following parameters

CPD Solution
Extractable Volume
Needle Checked
(Required Volume____)
Assy. By
S.N. Time M/C No.

Nozzle no.1 Nozzle no.2

1
2
3
4
5
6
7
8
9
10

11

12

13

14

15

16

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 10 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

SAG-M Solution

Extractable Volume
Needle Checked
(Required Volume____)
Assy. By
S.N. Time M/C No.

Nozzle no.1 Nozzle no.2

1
2
3
4
5
6
7
8
9
10

11

12

13

14

15

16

Work Description Record in Mixing And Filling

Stage Name of Person engaged

Mixing
Filling of Bags
Needle Fixing

(G) Filling Yield Calculation: CPD Solution

Batch Final volume, Ltr (A) :

Flush Volume, Ltr. (B) :

Dead space volume after filling, Ltr (C) :

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 11 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
In-process loss @ 5% of A, Ltr (D) :

Actual used volume in ltr [A-(B+C+D)] (E) :

Average Fill Volume, ml (F) :

Total Filled Bags (G) :

Actual Solution yield % (E*100/A*1000) :

(G) Filling Yield Calculation: SAG-M Solution

Batch Final volume, Ltr (A) :

Flush Volume, Ltr. (B) :

Dead space volume after filling, Ltr (C) :

In-process loss @ 5% of A, Ltr (D) :

Actual used volume in ltr [A-(B+C+D)] (E) :

Average Fill Volume, ml (F) :

Total Filled Bags (G) :

Actual Solution yield % (E*100/A*1000) :

(H) Reconciliation of Bags:

CPD Bag SAG-M Bag

Total bags received (A)

Total Units Filled (B)

Rejected Bags (C)

Reconciled B-C/A X 100

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 12 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
Performed By__________ Checked By_____________
(Production) (Quality Assurance)

5.0 STAGE: COILING AND POUCHING OF FILLED BAGS

Date of Activity: ____________

Process Start time________________ Process End Time_________________
A) Environmental Conditions:
Limit:
Temperature- 22±2 0 C Relative Humidity -NMT 55 % Positive Pressure- 15 mmWG
Observation:
Temperature- Relative Humidity- Positive Pressure:

B) Line Clearance :
Perform the line clearance as per SOP No…….by ensuring following points:

S. Activities Performed CheckedBy/date Checked

No. By(Production) (Production By/Date(QA)

Ensure that all the leftovers of previous

1. batch are removed from the area and
machine.

2. Ensure that all the rejections of the

previous batch removed from the area

3. Ensure that documents of previous batch

have been removed from the line

4. Ensure that no any other materials are

kept in the area except relevant batch.

C) Coiling and Pouching

 Perform the coiling and pouching of blood bags as per SOP No….

RECORD OF MATERIAL
Material Op. Control Qty. Control Qty. Qty. Closing
Name Balance No. Recd. No. Used Rej. Balance
Laminated

Pouch

Performed by/Date:__________________ Checked by/Date:____________________

Pouch Sealing Machine Parameter:
Parameter (Webomatic Machine)

Limit Setting
Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 13 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

Vacuum
Temperature
Air

Performed By/Date:____________________ Checked By/Date:_____________________

D) Visual Inspection Record at Coiling & Pouching Stage

Sample Qty.: 100% Visual Inspection Total no. of bags checked____________

Type of Defects Rejection

Leakage bags
Sheet spot on bag
Tube spot
Port spot
Label spot
Label pasting
Pouch sealing
Stamp problem
Particle in solution
Bag sealing problem
Needle bend
Solution volume problem
Others
Total Units Rejected

Total units taken by QA/QC for in-Process

inspection (if any)
Total Units transferred to sterilization

Work Description Record

Stage Name of Person Engaged

Coiling & pouching of Bags
Inspection of bags
Sealing of bags

6.0 STAGE: STERILIZATION (Sterilizer ID. ----------)

Date of Activity: ____________

Process Start time________________ Process End Time_________________

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 14 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
(A) Line Clearance
 Perform the line clearance as per SOP No…..by ensuring the following points:
S. Activities Performed Checked Checked
No. By(Production) By(Production By/date(QA)

Ensure that all the leftovers of previous batch

1.
are removed from the sterilizer.

Ensure that all the rejections of the previous

2.
batch removed from the area.

Ensure that documents of previous batch

3.
have been removed from the line

Ensure that no any other materials are kept

4.
in the area except relevant batch.

(B) In- Process Inspection of TrolleyLoading

Bags Total Orientati

S. Trolley Total Qty/ Checked
Time /Tray Tray/Trolley on Of Dislocation
No. No. Trolley By
Bags

(C) Cycle wise Record of Loaded Quantity

Trolley Trolley Total
Cycle No. ID. No. QTY. ID. No. QTY. Qty./Cycle

(D) Sterilization Process Activity:

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 15 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
 Check all utilities (Water, Compressed air, Steam and Electricity) required for sterilizer area
available.

 Check trolley loading before sterilization

 Perform the sterilization process as per SOP No….

 Observe change in color of sterilization tape after sterilization-

Before sterilization:

After Sterilization:

C-1 C-2

Color of Chemical indicator: - Changed/Not Changed Checked By/Date____________

(Production)
(E) Sterilization Process Record
Parameter Specification
Vessel Temperature
Exposure Time
Pressure (Exposure) Bar
Air Pressure (Cooling) Bar

Sterilization
Sterilization
Sterilization Cycle Cycle
Sr. Cycle Quantity/ Cycle Hold Done
Hold Start Duration Completion Status/
No. No. Cycle Start Time Completion By
Time Time Indicator
Time
color

(F) Sterilization Cycle Parameter Review:

Cycle No 
Parameter Specification

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 16 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
Vessel
Temperature
Exposure phase
Exposure Time
Pressure
(Exposure) kg/cm2
Air Pressure
(Cooling) kg/cm2
Checked By
(Production)

Reviewed By (Q.A.)

7.0 STAGE: DRYING OF BLOOD BAGS

Date of Activity:____________
Process Start time________________ Process End Time_________________
(A) Line Clearance
 Perform the line clearance as per SOP by ensuring the following points:

S. Activities Performed Checked Checked

No. By(Production) By(Production) By(QA)

1. Ensure that all the leftovers of previous

batch are removed from the dryer.
Ensure that all the rejections of the
2. previous batch removed from the dryer.

Ensure the cleaning of the

3.
equipment.

B) Drying: Drying process to be done as per SOP NO….

Dryer Id. Specification

Date of Activity
Set Temp. -
Set Temperature of Dryer Actual Temp.-
Drying start time
Drying completion Duration of Drying
time/Date
Total Duration of Drying

Cooling start time

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 17 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
Cooling completion
time/Date
Performed By/Date
Checked By(QA)

Quantity loaded in to Trolley (Y)

Rejection during unloading (R) _______________
Performed By
Sample For Testing Purpose (A)
Units Transferred to Final packing P(Y-
(R+A)
Checked By (QA)
Reconciled (P/Y) X 100

Reconciliation:

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 18 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

(As per Rules, 74, 74-A, 74-B, 78 and 78-A of Drugs & Cosmetics Rules, 1945 & GMP)

8.0 STAGE: ALUMINIUM POUCH LABEL PRINTING

Date of activity-
Process Start time________________ Process End Time_____________
A) Line Clearance: Perform the line clearance as per SOPNo…………. by ensuring the following
points:

S. No. Activities Performed Checked Checked

By(Production) By(Production) By(QA)

Ensure that all the leftovers of previous

1.
batch are removed from the area & machine.

Ensure that all the rejections of the previous

2.
batch removed from the area and machine.

Ensure that documents of previous have

3.
been batch removed from the line

Ensure the cleaning of the equipment and

4.
printed room area as per SOP No…

B) Equipment Used:.
C) Printing: Perform the aluminium pouch label printing of the relevant batch.
D) Printed aluminim pouch label , duly signed by production and QA person, shall be attached
along with the BMR
E) Reconciliation of Aluminum Pouch labels:

OK label
Qty. QC Rejected
Control transferred to Reconciliation
Type Recd. Sample Labels
No. Next stage D/A *100
‘A’ ‘B’ ‘C’
‘D’ =A-(B+C)

Performed By/Date:______________________ Checked By/Date:__________________

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 19 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:
9.0 STAGE: FINAL INSPECTION AND PACKING

Date of Activity: ____________

Process Start time________________ Process End Time_________________
A) Line Clearance
 Perform the line clearance as per SOPNo….. by ensuring the following points:
S. Activities Performed Checked Checked
No. By(Production) By(Production) By(QA)

Ensure that all the leftovers of previous batch

1. are removed from the inspection, sealing &
packing area and aluminum pouch sealing m/c.

Ensure that all the rejections of the previous

2.
batch removed from the area and machine.

Ensure the cleaning of the LAF & area as per

3.
SOP No…..

B) Packing: Perform the packing process to be done as per SOP.

VISUAL INSPECTION OF BLOOD BAGS/CARTONS

Total Nos. of Bags Checked:_____________________

Type of Defects Rejection

Moisture in pouch

Leakage in bags

Sheet/tube/port/label spot

Label pasting

Pouch sealing

Particle in solution

Bag sealing problem

Needle bend

Tube kink

Weight Problem
Completeness of printed information on inner label,
aluminum pouch & cartons labels
.
Others
Total Units Rejected

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 20 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

RECORD OF MATERIAL
Material Op. Control Qty. Control Qty. Ok Qty. Reconcile.
Name Bal. No. Recd. No. Rej. E (A+B)- D E/A+B*100
A B D
Al.
Pouch
Cartons

Note: If the material required for next online batch is same as closing balance than closing balance can be used
for this batch otherwise balance quantity to be returned to store.
Checked By:______________ Date: ________________

Quantity received from sterilization (Y)

For QC testing + Control Sample (T) ______________
Performed By/Date
Rejection during visual inspection (R)
Units Transferred to warehouse P=Y-
(T+R)

Reconciled (P /Y) X 100 Checked By/Date (QA)

Reconciliation of bags:

Work Description Record

Stage Name of Person Engaged

Visual inspection
Aluminum pouch packing
Aluminum pouch sealing
Carton packing

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 21 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

No. of empty bags received for filling (Y)

Total No. of bags filled (P)

_______________
Rejection during Filling (R1) Performed
By/Date
Rejection during pouch sealing & visual
Inspection (R2)

Rejection during autoclaving & drying (R3) _______________

Checked By /Date
Rejection during visual inspection & Final QA)
packing (R4)

Total rejection (R = R1+ R2 + R3 + R4)

Rejection % (R/Y)* 100

Theoretical Yield (Nos.)

(Equivalent to Y)

For QC testing + Control Sample (T)

Units Transferred to warehouse (W)

Actual Yield (Nos.)W+T

Actual Bag Yield % W+T/Y*100

Final product Yield:

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 22 of 23
 BIOLIFE MEDICAL PVT LTD
D 31, SITE IV, KASNA, GREATER NOIDA 201 306, U. P., INDIA

BATCH MANUFACTURING RECORD-QUADRUPLE BLOOD BAG ( CPD –IP/ SAGM Solution)

Batch Number: Product Code:

10.0 BATCH REVIEW RECORD

REVIEW BY PRODUCTION
The Batch has been manufactured under my supervision strictly as per the laid down procedures.

_______________________
Approved Manufacturing Chemist/Date

BATCH TRANSFER RECORD(QUARANTINE AREA)

Qty transferred to ware house____________ Date:___________________

IDC Slip No.______________________

Transferred By/Date______________ Received By/Date ______________________

REVIEW BY QUALITY ASSURANCE

All the attached records of manufacturing and testing of this batch in this BMR has been reviewed
and found satisfactory/not satisfactory.
REMARK:__________________________________________________________________

_______________________
Reviewed By/Date

Signature Date
Checked By Production
Reviewed By QA

BL-BMR-BB-002 Page 23 of 23