Good Stuff Pharmaceuticals
Instrument Data Form
Part A To Be Completed By Originator
If there are questions, please contact the Calibration or Metrology Group for assistance.
Section 1: Reason for Request (Check all that apply):
ADDITION
New
Re-commissioned
MODIFICATION
Exact Replacement
Approved Functional Equivalent
DELETION
Change of Parameter
Relocated/Transferred
Decommissioned
Cannot Locate
Section 2: Instrument Identification (If a replacement or change, original identification #: _________________________________)
1.
2.
3.
4.
5.
6.
7.
8
9
Instrument Type: (Indicator, Recorder, Transmitter, pH, HPLC, etc.)
Equipment/System & Parameter Instrument is monitoring:
Portable Instrument:
YES
NO
Manufacturer:
Model:
Serial Number:
Manufacturers Documentation Provided:
YES
NO
Laboratory Analytical Instrument:
YES
NO
If YES, Qualification Required:
YES
NO
Instrument Location
10.
Department:
(Items below are for general information for portable instruments):
11.
12.
13.
Building:
Floor & Area:
Specific Location/Room:
Section 3: Operations Technical Data
14. Approximate use point or range of use (units):
15. Input (Device) Range of Instrument as configured: ______________________ Units of Measure:
16. Requested Calibration Test Point(s):
Three calibration points are normally specified in the program (approximately 0-10% of range, 45-55% of range and 90-100% of range).
Provide this information ONLY if an additional or fewer test points other than those listed above are requested. Provide explanation for request in Section 4.
And
Or
calibration test points:
%FS
%Reading
Total Test Points
17. Output Signal Range (as applicable): Range: ______________________ Units of Measure: _____________
Units
18. Characterization (Check One): GMP
Non-GMP
19. Classification (Check One - only if characterized as GMP):
GMP Critical
GMP Non-critical
GMP Utility
20. Calibration Frequency: (Use only if a schedule other than procedure stipulated intervals of 6 months for GMP Critical or 12 months for GMP
Non-critical instruments or for GMP Utility Instrument is requested.)
Monthly
Schedule:
Quarterly
Semi-annual
Annual
Feb
Mar
Aug
Sep
Jan
Jul
Specify the month(s) calibrations are to be performed if
particular months are requested for operational
purposes:
21. Process Calibration Tolerance:
Apr
Oct
May
Nov
Jun
Dec
(%FS, %Reading, or Units)
(For Instruments classified as GMP Critical, the limit of calibration error allowed before quality is potentially compromised. Not applicable for
devices to be calibrated as a loop or test/laboratory instruments used for different functions.)
22. Source/Reference for Process Calibration Tolerance:
23. Is device part of a loop?
YES
NO
If YES, identify loop components:
Component: A
this device:
Component B:
Component C:
(Use Section 4 if required)
Component D:
Component E:
Component F:
Attach Instrument Data Forms for all components and Loop Data Form for Loop Calibrations
Section 4:
Comments and Characteristics: (Identify any special characteristics, e.g. non-linearity, special hysteresis or temperature
concerns or special uses.)
Originator (Signature):
Name (printed):
Date:
Page 1 of 2
Good Stuff Pharmaceuticals
Instrument Data Form
Part B To be competed by Calibration/Metrology Group
24. Instrument Manufacturers Stated Accuracy (%FS,
%Reading, or units):
25. Device Calibration SOP Identification (if SOP is to be used) :
26. Instrument Calibration Limits:
27. New Calibration Sheet required:
YES
NO
If YES, attach new Calibration Sheet for routing and approval
28. P&ID Drawing Number (if any)
29. P&ID Tag Number (if any):
Note: Instruments classified as GMP Utility may not require a calibration SOP or Calibration Sheet. If the instrument is classified as
GMP Utility, a Preventive Maintenance Task may used to check the instrument if it is not to be calibrated. Verify that a Preventive
Maintenance Task has been developed for the GMP Utility functionally checked instrument within the CCMS or CMMS.
30. Preventive Maintenance Task established for GMP Utility instrument:
YES
NO
If NO, explain the reason in Section 32, Explanations and General Comments, below.
31. Identify any exceptions to calibration program requirements: (Examples: Less than full range calibration, Non-standard calibration
frequency, lack of repeatability challenges, etc.)
Minimum Three Point
Calibration?
Full Range Calibration?
YES
NO
YES
NO
32. Explanations and General Comments:
Part B Prepared By (Signature):
Procedure Specified Calibration
Frequency?
YES
NO
Process Calibration Tolerance s set?
(GMP Critical only)
YES
Repeatability challenges developed?
(Mechanical devices or Identified
Electromechanical devices only)
NO
YES
Name (printed):
Date:
Name (printed):
Date:
Name (printed):
Date:
NO
Part C Return to Originator
33. Request returned to Originator (reasons):
By (Calibration/Metrology Signature):
Part D Review And Approvals
Calibration/Metrology Group Supervision (Signature):
Only Calibration/Metrology Group approval is required for Exact Replacements and increasing the frequency of calibration.
End User Department (Signature):
Name (printed):
Date:
Quality Control (Signature):
Name (printed):
Date:
Part E CMMS Entry Verification
Entered By (Signature):
Name (printed):
Date Entered:
Entry Reviewed By (Signature):
Name (printed):
Date Entered:
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