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:

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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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