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Production Batch Record for Homogenization of Proleukin

Document Number:_________________
Part Number(s):____________________

Production Batch Record for Homogenization


of Proleukin

BATCH RECORD ISSUANCE


Issued By:__________________________________________________________________________
Print Name
Signature
Date

1. SIGNATURE:
1.1 Sign below if your initials appear in this document.

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Signature

Initials

Printed Name________________________________________________________________
Printed Name________________________________________________________________
Signature

Initials

Signature

Initials

Signature

Initials

Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Signature

Initials

Signature

Initials

Signature

Initials

Printed Name________________________________________________________________
Printed Name________________________________________________________________

Production Batch Record for Homogenization of Proleukin


Document Number:_________________
Part Number(s):____________________

2.

REFERENCES:

DOCUMENT OR SOP NUMBER: 5-10/5


TITLE: Standard Operation Procedure of Homogenization of Proleukin.

3. CHEMICAL MATERIAL:
Verify that the correct materials are provided. Attach Materials Management kit label to the batch
record.

Material Description:

Buffer

Redox reagent

Dilute

Storage Condition:

________________

________________

________________

Amount Required:

________________

________________

________________

Verified By:

________________

________________

________________

________________

________________

________________

Part Number:

Production Batch Record for Homogenization of Proleukin


Document Number:_________________
Part Number(s):____________________

4. PROCEDURE:

Step#

Operational Description

Be sure the equipment is calibrated


and write the date of calibration
1.1 Be sure the sensors are calibrated and
write down last date of calibration

1.2 Make sure that the pH is set at _____


in the software

1.3 Pressure______
1.4 Pump speed_______
1.5 Note the temperature______
1.6 Number of cycles______
1.7 Make sure that the procedure follow
the SOP require.
Comment:

Data Entry

Perform By/

Verify By/

Date

Date

Production Batch Record of Affinity Chromatography for Proleukin


Document Number:_________________
Part Number(s):____________________

Production Batch Record of Affinity


Chromatography for Proleukin

BATCH RECORD ISSUANCE


Issued By:__________________________________________________________________________
Print Name
Signature
Date

1. SIGNATURE:
1.1 Sign below if your initials appear in this document.

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signatur

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Production Batch Record of Affinity Chromatography for Proleukin


Document Number:_________________
Part Number(s):____________________

2.

REFERENCES:

DOCUMENT OR SOP NUMBER: 5-10/7


TITLE: Standard Operation Procedure of Purification and Chromatography for Proleukin.

3. LIST OF SUPPLIES:

ITEM DESCRIPTION:
PART NUMBER:
AMOUNT REQUIRED:

4. RAW MATERIAL AND COMPONENTS:


Verify that the correct materials are provided. Attach Materials Management kit label to the batch
record.

Material Description:

________________

________________

________________

Part Number:

________________

________________

________________

Storage Condition:

________________

________________

________________

________________

________________

________________

________________

________________

________________

Amount Required:
Verified By:

5. CHEMICAL MATERIAL:

Acetonitrile

Milli-Qwater

Trifluoroaceticacid

Part Number:

________________

________________

________________

Storage Condition:

________________

________________

________________

Amount Required:

________________

________________

________________

Amount Used:

________________

________________

________________

Material Description:

Production Batch Record of Affinity Chromatography for Proleukin


Document Number:_________________
Part Number(s):____________________

Batch #:

________________

________________

________________

Exp. Date

________________

________________

________________

Entered By:

________________

________________

________________

Verified By:

________________

________________

________________

6. EQUIPMENT:
Record the Serial or ID Number and the calibration due date of the equipment needed to perform the
procedure.

________________

________________

________________

Equipment Serial or ID Number: ________________

________________

________________

Calibration Due Date:

________________

________________

________________

Recorded By/Date:

________________

________________

________________

Verified By/Date:

________________

________________

________________

Equipment Name:

Production Batch Record of Affinity Chromatography for Proleukin


Document Number:_________________
Part Number(s):____________________

7. PROCEDURE:

Step

Operational Description

Preliminary Operations
____ amount of buffer A
____ amount of buffer A
Comment:

Load Sample Preparation

Make sure to prepare harvest at


follow SOP.
Comment:

Column Preparation

Make sure the temp. at 4C.


Make sure the run should be at
1ml/min.
Make sure the detection
wavelength at 214.
Comment:

Cycle Process

Make sure to run the buffer as


follow SOP.
Use a linear gradient to elute the
harvest.

Data

Perform By/

Verify By/

Entry

Date

Date

Production Batch Record of Affinity Chromatography for Proleukin


Document Number:_________________
Part Number(s):____________________
Step

Operational Description

Data

Perform By/

Verify By/

Entry

Date

Date

Comment:
Comment:

8. CYCLE DATA:

Table Cycle 1
Ref. #

Parameters

(1)

File Name

(2)

Buffer pH

(2)

Buffer Condition

(3)

Equil. pH

(3)

Equil. Condition

mS/cm

Equil Range Met?


(4)

Equil. Buffer Vol

(5)

Zero UV1?

(6)

Load Volume

(7)

ElutionA
(Event Log)

(8)

Mixing Speed

(9)

Mixing Time

(10)
(11)
(12)
(13)
(14)

Units Perform By/ Verified By/


Date
Date

Data Entry

YES
End

Start
YES

Total

L
End

Start

Total

L
Hz/
Rpm

Start

End

Production Batch Record of Packaging and Labeling for Proleukin


Document Number:_________________
Part Number(s):____________________

Production Batch Record of Packaging and


Labeling for Proleukin

BATCH RECORD ISSUANCE


Issued By:__________________________________________________________________________
Print Name
Signature
Date

1. SIGNATURE:
1.1 Sign below if your initials appear in this document.

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signatur

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Printed Name________________________________________________________________
Signature

Initials

Production Batch Record of Packaging and Labeling for Proleukin


Document Number:_________________
Part Number(s):____________________
2.

REFERENCES:

DOCUMENT OR SOP NUMBER: 5-10/1


TITLE: Standard Operation Procedure of Packaging and Labeling for Proleukin.

3. LIST OF SUPPLIES:

ITEM DESCRIPTION:
PART NUMBER:
AMOUNT REQUIRED:

4. RAW MATERIAL AND COMPONENTS:


Verify that the correct materials are provided. Attach Materials Management kit label to the batch
record.

Material Description: ________________

________________

________________

Part Number:

________________

________________

________________

Storage Condition:

________________

________________

________________

Amount Required:

________________

________________

________________

Verified By:

________________

________________

________________

5. MATERIAL:

Material Description: Labels

Vials

________________

________________

________________

________________

________________

________________

________________

Amount Required:

________________

________________

________________

Amount Used:

________________

________________

________________

Batch #:

________________

________________

________________

Part Number:
Storage Condition:

Production Batch Record of Packaging and Labeling for Proleukin


Document Number:_________________
Part Number(s):____________________
________________

________________

________________

Entered By:

________________

________________

________________

Verified By:

________________

________________

________________

Exp. Date

6. PROCEDURE: 3

Step

Operational Description

1
1.1

Make sure that the vials follow the


require testing.

1.2

Make sure to check if all of the air in


the vent is within limits.

1.3

Make sure that all vials have not


been tampered and seals are intact.

1.4

Amount in each vial _________

1.5

Make sure to place the orange code


sticker on vial.

1.6

Make sure to label the rack.

1.7

Temperature of the room _______

1.8

Comment:

Filling Vials with drug

Labeling of Medication

2.1

Make sure that the area is sterilized


before starting.

2.2

Be sure that every batch has own


paperwork and approved it.

2.3

Fill Vials according to SOP 5-10/1

2.4

Make sure it only take place in


authorized area for labeling.

Data

Perform By/

Verify By/

Entry

Date

Date

Production Batch Record of Packaging and Labeling for Proleukin


Document Number:_________________
Part Number(s):____________________
Step

Operational Description

2.5

Make sure that only one medication


should be labeled at one time.

2.6

Be ensure that the area is clean and


all of the required air ventilation is
turned on

2.7

Be sure that the temperature of the


room is between 65 and 75 !F to
assure medicine stability.
Comment:

Data

Perform By/

Verify By/

Entry

Date

Date

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