The difference at a glance
Protocol and report belong together, but they serve a different moment and purpose. The protocol is the agreement before the study. The report is the evidence afterwards.
| Mapping protocol | Mapping report | |
|---|---|---|
| When | Before measurement | After measurement |
| Purpose | Define what you measure and how | Document what the measurement showed |
| Includes, for example | Scope, objectives, methodology, measurement points, duration, tests and acceptance criteria | Results summary, conclusions, graphs, raw data, deviations and calibration certificates |
| Acceptance criteria | Defined in advance | Assessed afterwards |
| Approval | Approved in advance by QA or the responsible person | Reviewed, checked and signed after the study |
| Audit status | The plan and the agreement | The evidence and the conclusion |
What is a mapping protocol?
A mapping protocol is prepared, reviewed and approved before the measurement starts. It explains why the area is mapped, which storage condition must be demonstrated and how the study will be performed.
A robust protocol includes at least the scope, rationale, objectives, measurement points, measurement heights, logging interval, study duration, data loggers used, tests to be performed and acceptance criteria. It also states whether the area is assessed empty, loaded or under representative operating conditions.
Measurement points and the grid are therefore justified in advance. For practical guidance, read how many measurement points are needed for temperature mapping.
What is a mapping report?
The mapping report is prepared after the study. It describes the completed measurement, summarises the results and compares the data with the acceptance criteria in the protocol. This shows whether the area is suitable for its intended storage use.
A report normally includes an introduction, summary, conclusions and recommendations, raw data, graphs per logger, hot and cold spots, deviations, CAPA where required, calibration certificates and an overview of the logger locations used.
Do you want to see what such a dossier should contain in practice? See the page sample temperature mapping dossier. It sets out the report and dossier structure in a practical way.
How protocol and report fit together
In practice, a mapping study follows four steps: prepare the protocol, perform the measurement, prepare the report and implement the recommendations. The report mirrors the protocol. The same scope, measurement setup and acceptance criteria return, now with the actual measurement results.
The report should not be written towards a desired outcome. If the execution deviates from the protocol, for example because a logger was moved, failed or a test was changed, this should be recorded and justified as a deviation.
Position within qualification and validation
In GMP and GDP environments, temperature mapping is not separate from qualification and validation. Mapping is often used as part of the OQ or PQ of a storage room, cold room, freezer or warehouse.
The protocol defines the critical parameters and acceptance criteria. The report then records whether the area performs within those limits. After significant changes, such as refurbishment, changed loading patterns or HVAC adjustments, re-mapping may be required through change control.
Acceptance criteria: the connecting point
Acceptance criteria connect the protocol with the report. They are defined in advance in the protocol. In the report, the measurement results are assessed against them. Without pre-defined criteria you can still describe what was measured, but a formal pass or fail conclusion is less strongly supported.
Examples include the permitted temperature range, the permitted duration of a short excursion, requirements after door opening and any humidity criteria. The criteria must fit the product, storage condition and intended use of the area.
Common mistakes
- Defining acceptance criteria only in the report instead of in the protocol beforehand.
- Starting the measurement without an approved protocol.
- Not recording deviations during execution.
- Leaving calibration certificates or raw data out of the report.
- Not having the report independently checked or signed.
- Using a report structure that does not follow the protocol.
Sources used
This page is based on the practical principles in WHO TRS 992 Annex 5 Supplement 8, EU GMP Annex 15, EU GDP 2013/C 343/01 and the ISPE Good Practice Guide for controlled temperature chambers.
Further reading
This page belongs to the temperature mapping knowledge cluster. Also read what is temperature mapping, hot spots and cold spots, temperature mapping guidelines and what is included in a mapping dossier.
Preparing for an audit? Also read what auditors want to see in a temperature mapping.