- Protocol preparation, review and approval
- Identification of team members
- Definitions and Acronyms
- Scope
- Objective
- Rationale
- Applicability
- Responsibility
- Documentation
- Temperature & humidity distribution verification report
- Warehouse Description
- Change history
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Name |
Designation |
Signature |
Initial |
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Terms |
Definitions |
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Change Parts |
Parts to fit different size / format
or application. |
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Deviation |
Any discrepancy between the protocol
and the actual performed test, test function methodology etc. |
|
 Instrument |
A device that interprets a mechanical,
digital or analog signal generated by a sensor, and converts it into
engineering units (°C, % RH etc.) through scaling. |
|
Key Operating Parameters |
Parameters that must be maintained to
process or produce products with consistent quality attributes and those that
may have an impact on the proper operation of the equipment. |
|
Main Equipment |
Major equipment to be qualified. |
|
Data logger |
An electronic device that records data
overtime or in relation to location either with a built-in instrument or
sensor or via external instruments and sensors |
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Mapping |
Documented testing that demonstrates
with high a degree of assurance that a specific process will meet its
pre-determined acceptance criteria. |
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GMP |
Good Manufacturing Practices |
|
 RH |
Relative Humidity |
|
ID |
Identification |
|
NA |
Not Applicable |
|
NIST |
National Institute of Standards and
Technology |
|
CFR |
Code of Federal Regulations |
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PM |
Preventive Maintenance |
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QA |
Quality Assurance |
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QC |
Quality Control |
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S/N |
Serial number |
|
Study
type |
Temperature
and Humidity Mapping study |
|
Asset Type |
Warehouse |
|
Description |
Warehouse-Raw Material area |
|
Temperature range to be mapped |
Low limit 15°C High limit 30°C |
|
Humidity range to be mapped |
NMT 65% |
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Duration of testing |
7 days |
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Date of Testing |
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- Temperature mapping study to analyze distribution of temperature inside the whole area.
- Humidity mapping study to analyze distribution of humidity inside the whole area.
- Briefly describe the equipment, its major components and their roles.
- Ensure that appropriate identification and documentation are in place.
- Ensure that the physical characteristics are compatible with planned equipment utilization.
- Ensure that appropriate operation procedures and training program are in place.
- Hot and Cold points of the Warehouse will be identified.
- This mapping study will be carried out for summer season.
- Number of data loggers are determined based on the volume of the Warehouse and as per relevant WHO Standards.
- Temperature & humidity distribution of Warehouse under loaded condition
- The temperature & humidity distribution verification must be conducted by trained and experienced technical personnel and must be documented in a scientific manner using this established format.
- The study is meant to be representative and to be close to the real use of the warehouse. The temperature & humidity distribution study is to be executed during normal working condition and data loggers will be placed in different identified locations in the warehouse.
- iButton Temperature & humidity Data Loggers will be used to measure and record temperature & humidity. Each data logger has been calibrated and calibration certificates included in the reports will be attached to the report.
- Cold chain thermodynamics software will be used to program data loggers, to download data and to generate reports which are compliant to PIC/S GMP Annex 11 and 21 CFR Part 11 requirements.
- The temperature & humidity distribution verification documented in this protocol only covers Warehouse-Raw Material area.
|
Task |
Quality
Assurance |
Warehouse |
|
Make available all technical
documentation required for the mapping of the warehouse. |
√ |
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Collect information. |
√ |
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Write the protocol. |
√ |
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Review and approve the protocol. |
√ |
√ |
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Coordinate activity. |
√ |
√ |
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Execute the test described in the
protocol. |
√ |
√ |
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Compile and analyze data. |
√ |
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Issue the final report. |
√ |
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Review and approve the final report. |
√ |
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- All manual entries will be written in indelible blue ink.
- Any error must be crossed out with a single line stroke, and the correct information must be entered below or above the error.
- All corrections must be initiated and dated.
|
Section |
Description |
|
Data |
Schema, tables, raw data, summary
tables. |
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Comments |
Discussion of any unusual observations
during the test or significant test conditions not defined in the test
procedure. |
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Tested by |
Signature and corresponding date for
the person performing the test. |
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Verified by |
Signature and corresponding date for
the person verifying the test data. |
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Section |
Description |
|
Objective |
Description of the objectives of the
Warehouse temperature & humidity distribution verification. |
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Results |
Compilation of results obtained |
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Summary |
Summary and discussion of the results
of the execution of this protocol. |
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Conclusion |
General conclusion of the temperature
& humidity distribution verification inside the warehouse. |
