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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

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Printed Name

 

Signature

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Printed Name

 

Signature

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Signature

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Signature

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Signature

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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:

Part Number:

Bu!er

Storage Condition:

Amount Required:

Verified By:

Redox reagent

Dilute

Production Batch Record for Homogenization of Proleukin Document Number:

Part Number(s):

4.

PROCEDURE:

Step#

Operational Description

Data Entry

Perform By/

Verify By/

Date

Date

1

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:

     

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:

Material Description:

Part Number:

Storage Condition:

Amount Required:

Amount Used:

Acetonitrile

Milli-Qwater

Trifluoroaceticacid

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 Name:

Equipment Serial or ID Number:

Calibration Due Date:

Recorded By/Date:

Verified By/Date:

Production Batch Record of Affinity Chromatography for Proleukin Document Number:

Part Number(s):

7.

PROCEDURE:

Step

Operational Description

Data

Perform By/

Verify By/

#

Entry

Date

Date

1

Preliminary Operations

     
 

amount of buffer A

     
 

amount of buffer A

     
 

Comment:

     

2

Load Sample Preparation

     
 

Make sure to prepare harvest at follow SOP.

     
 

Comment:

     

3

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:

     

4

Cycle Process

     
 

Make sure to run the buffer as follow SOP.

     
 

Use a linear gradient to elute the harvest.

     

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

 

Data Entry

 

Units

Perform By/

Verified By/

Date

Date

(1)

File Name

         

(2)

Buffer pH

         

(2)

Buffer Condition

       

(3)

Equil. pH

         

(3)

Equil. Condition

 

mS/cm

   
 

Equil Range Met?

 

YES

     

4

                 

(

)

Equil. Buffer Vol

 

-

 

= L

 

End

Start

Total

(5)

Zero UV1?

 

YES

     

(6)

Load Volume

 

L

   

(7)

Elution A

         

= L

     

(Event Log)

End

-

Start

Total

 

Mixing Speed

 

Hz/

   

(8)

Rpm

9

Mi

i

Ti

         

(

)

x ng

me

Start

   

End

(10)

         

(11)

         

(12)

         

(13)

         

(14)

         

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:

Part Number:

Labels

Storage Condition:

Amount Required:

Amount Used:

Batch #:

Vials

Production Batch Record of Packaging and Labeling for Proleukin Document Number:

Part Number(s):

Exp. Date

Entered By:

Verified By:

6.

PROCEDURE: 3

Step

Operational Description

Data

Perform By/

Verify By/

#

Entry

Date

Date

1

Filling Vials with drug

     

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:

     

2

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.

     

Production Batch Record of Packaging and Labeling for Proleukin Document Number:

Part Number(s):

Step

Operational Description

Data

Perform By/

Verify By/

#

Entry

Date

Date

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.

     
 

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