Today we are going to discuss how to carry out a systematic mapping procedure in any cold room, freezer rooms or other temperature-controlled store
All new temperature-controlled storage areas must be temperature-mapped as part of a fully documented verification process, before the installation is commissioned and handed over by the installer.
2.0. The temperature mapping procedures should:
Demonstrate the air temperature profile throughout the storage area, when empty and in a normal loaded condition;
- Define zones which should not be used for storage of TTSPPs “Time and temperature sensitive pharmaceutical product” (for example areas in close proximity to cooling coils, cold air streams or heat sources); andIf required, demonstrate the time taken for temperatures to exceed the designated limits in the event of power failure.
- Depending upon the routine monitoring strategy, subsequent mapping exercises may also be required on a periodic basis – for example, every three years – in order to demonstrate continuing compliance.
All mapping exercises should be fully documented in order to demonstrate compliance to management, clients and the regulatory authorities.
3.0. A temperature mapping exercise involves a four stage process, as follows:
- Prepare a mapping protocol.
- Carry out the mapping exercise
- Prepare a mapping report.
- Implement the recommendations by carrying out the remedial and other actions identified in the mapping report. A follow-up mapping exercise may then be needed to verify the effectiveness of the remedial actions.
3.1. The mapping protocol
A detailed and comprehensive protocol should be prepared, reviewed and approved before the mapping exercise begins. A well-designed protocol will help ensure that the mapping study is correctly carried out. With suitable adjustments or options to cover the full range of temperature regimes, a standard protocol can be used to map any storage area in the facility.
3.2. The mapping protocol should contain the following sections:
- Approval page and change control history.
- Acronyms and glossary.
- Description and rational
- Mapping report template.
- Annexes as needed, including templates for the mapping report
- STEP 1 – select EDLMs:
- STEP 2 – designate the mapping team:
- STEP 3 – survey the site:
- STEP 4 – establish acceptance criteria:
- STEP 5 – determine EDLM locations:
- STEP 6 – record EDLM, monitoring sensors and thermostat locations:
- STEP 7 – label and program the EDLMs:
- STEP 8 – fix EDLMs in position:
- STEP 9 – conduct the mapping exercise:
- STEP 10 – download and consolidate the data:
3.4. Mapping report template:
The mapping report should include the following sections:
- Introduction: a description of the objectives of the mapping study.
- Summary: a summary and discussion of the results organised in the sequence set out in the mapping protocol, including a summary of deviations (if any).
- Conclusions and recommendations: a general conclusion for all verification’s and observations indicating the acceptability of the equipment for operating Recommendations and remarks can be incorporated as well.
- Report annexes: The report annexes should contain the following:
- The site survey, showing EDLM locations.
- The raw data, presented using the appropriate test data sheet format
- Spreadsheet data and related temperature graphs for every EDLM used in the mapping exercise.
- Raw results of the data analysis, including hot and cold spots.
- Key documents and notes prepared during the mapping exercise, together with any other supporting material.
- Deviation reports, including Corrective and Preventive Actions (CAPA) forms, if required. This may include a recommendation for partial or total re-mapping.Calibration certificates for all EDLMs used.
4.0. Implementing the mapping report recommendations:
The final outcome and purpose of a mapping exercise is the implementation of the report recommendations.
- Health Canada (HPFB Inspectorate): Guide 0069: Guidelines for temperature Control of Drug Products during Storage and Transportation. October 17, 2005. http://www.rxcritical.ca/pdf/Guide-0069.pdf
- IATA. 2013/2014 Perishable Cargo Regulations (ePCR) & Temperature Control
- Regulations (eTCR)
- PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment. Parenteral Drug Association. 2007. https://store.pda.org/ProductCatalog/Product.aspx?ID=1270
- United States Pharmaceopaedia: Chapter 1079: Good Storage & Shipping Practices. https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/c1079%20USP36.pdf
- United States Pharmaceopaedia: Chapter 1118: Monitoring Devices – Time, Temperature and Humidity. http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1118.html
- US Food and Drug Administration. Title 21–Food and Drugs. Chapter I–Food and Drug administration Department of Health and Human Services. Subchapter A— General. Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11.
- WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf