Document Number:_________________
Part Number(s):____________________
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________________________________________________________________
2.
REFERENCES:
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:
4. PROCEDURE:
Step#
Operational Description
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
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
2.
REFERENCES:
3. LIST OF SUPPLIES:
ITEM DESCRIPTION:
PART NUMBER:
AMOUNT REQUIRED:
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:
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.
________________
________________
________________
________________
________________
________________
________________
________________
Recorded By/Date:
________________
________________
________________
Verified By/Date:
________________
________________
________________
Equipment Name:
7. PROCEDURE:
Step
Operational Description
Preliminary Operations
____ amount of buffer A
____ amount of buffer A
Comment:
Column Preparation
Cycle Process
Data
Perform By/
Verify By/
Entry
Date
Date
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
(5)
Zero UV1?
(6)
Load Volume
(7)
ElutionA
(Event Log)
(8)
Mixing Speed
(9)
Mixing Time
(10)
(11)
(12)
(13)
(14)
Data Entry
YES
End
Start
YES
Total
L
End
Start
Total
L
Hz/
Rpm
Start
End
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
REFERENCES:
3. LIST OF SUPPLIES:
ITEM DESCRIPTION:
PART NUMBER:
AMOUNT REQUIRED:
________________
________________
Part Number:
________________
________________
________________
Storage Condition:
________________
________________
________________
Amount Required:
________________
________________
________________
Verified By:
________________
________________
________________
5. MATERIAL:
Vials
________________
________________
________________
________________
________________
________________
________________
Amount Required:
________________
________________
________________
Amount Used:
________________
________________
________________
Batch #:
________________
________________
________________
Part Number:
Storage Condition:
________________
________________
Entered By:
________________
________________
________________
Verified By:
________________
________________
________________
Exp. Date
6. PROCEDURE: 3
Step
Operational Description
1
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
Comment:
Labeling of Medication
2.1
2.2
2.3
2.4
Data
Perform By/
Verify By/
Entry
Date
Date
Operational Description
2.5
2.6
2.7
Data
Perform By/
Verify By/
Entry
Date
Date