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Production Batch Record for Homogenization of Proleukin
BATCH RECORD ISSUANCE
Issued By:__________________________________________________________________________
1. SIGNATURE:
1.1 Sign below if your initials appear in this document.
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Production Batch Record for Homogenization of Proleukin Document Number:_________________Part Number(s):____________________
1
Buffer Redox reagent Dilute
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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:
Storage Condition:
Amount Required:
Verified By:
Production Batch Record for Homogenization of Proleukin Document Number:_________________Part Number(s):____________________
2
4. PROCEDURE:
Step# Operational Description Data Entry Perform By/
Date
Verify By/
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 for Homogenization of Proleukin Document Number:_________________Part Number(s):____________________
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Print Name Signature Date
Signature
Signature
Signature
Signature
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Production Batch Record of Affinity Chromatography for Proleukin
BATCH RECORD ISSUANCE
Issued By:__________________________________________________________________________
1. SIGNATURE:
1.1 Sign below if your initials appear in this document.
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Production Batch Record of Affinity Chromatography for Proleukin Document Number:_________________Part Number(s):____________________
1
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Acetonitrile Milli-Qwater Trifluoroaceticacid
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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:
Production Batch Record of Affinity Chromatography for Proleukin Document Number:_________________Part Number(s):____________________
2
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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):____________________
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7. PROCEDURE:
Step
#
Operational Description Data
Entry
Perform By/
Date
Verify By/
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):____________________
4
Step
#
Operational Description Data
Entry
Perform By/
Date
Verify By/
Date
Comment:
Comment:
8. CYCLE DATA:
Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Table – Cycle 1Ref. # Parameters Data EntryData EntryData EntryData EntryData EntryData Entry Units Perform By/
DateVerified By/
Date(1) File Name
(2) Buffer pH
(2) Buffer Condition
(3) Equil. pH
(3) Equil. Condition mS/cm
Equil Range Met? YES YES YES YES YES YES
(4) Equil. Buffer Vol - = L(4) Equil. Buffer Vol End
- Start Start
= Total
L
(5) Zero UV1? YES YES YES YES YES YES(6) Load Volume L
(7) ElutionA
(Event Log) - = L(7) ElutionA
(Event Log) End-
StartStart =
TotalL
(8) Mixing Speed Hz/Rpm
(9) Mixing Time
(9) Mixing TimeStartStartStart EndEndEnd
(10)
(11)
(12)
(13)
(14)
Production Batch Record of Affinity Chromatography for Proleukin Document Number:_________________Part Number(s):____________________
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Print Name Signature Date
Signature
Signature
Signature
Signature
Signatur
Signature
Signature
Signature
Signature
Signature
Signature
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Signature
Initials
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Production Batch Record of Packaging and Labeling for Proleukin
BATCH RECORD ISSUANCE
Issued By:__________________________________________________________________________
1. SIGNATURE:
1.1 Sign below if your initials appear in this document.
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Printed Name________________________________________________________________
Production Batch Record of Packaging and Labeling for Proleukin Document Number:_________________Part Number(s):____________________
1
Labels
________________
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________________
Vials
________________
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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:
Storage Condition:
Amount Required:
Amount Used:
Batch #:
Production Batch Record of Packaging and Labeling for Proleukin Document Number:_________________Part Number(s):____________________
2
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________________
________________
________________
________________
Exp. Date
Entered By:
Verified By:
6. PROCEDURE: 3
Step
#
Operational Description Data
Entry
Perform By/
Date
Verify By/
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):____________________
3
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Step
#
Operational Description Data
Entry
Perform By/
Date
Verify By/
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.
Comment:
Production Batch Record of Packaging and Labeling for Proleukin Document Number:_________________Part Number(s):____________________
4
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