DOI: https://doi.org/10.24959/cphj.19.1508

The mapping procedure as an essential process during clinical trials

A. P. Komarova, K. O. Zupanets, O. O. Andrieieva

Abstract


A risk–based approach to the quality of clinical trial (CT) data provides the appropriate conditions for the use of materials at clinical trial site (CTS). One of the most important parameters requires careful monitoring of the temperature mode for storing samples. In case of any temperature failure there can be the data loss that may affect quality of any CT. The procedure of temperature mapping enables to confirm the uniformity and stability parameters of the temperature distribution within the freezers at CTS.
Aim. To analyze the guidelines regulating the quality of CT and develop a standard operating procedure (SOP) of the mapping process for freezing equipment at the CTS.
Materials and methods. At the Clinical and Diagnostic Center (CDC) of the NUPh the temperature mapping was performed according to the requirements of the WHO in order to prevent risks associated with temperature fluctuations in storage areas of biological samples. This procedure is quite important for the further installation of portable temperature registration systems (data loggers), which are necessary to monitor the temperature regime during CT.
Results. At the moment, the documents regulating the mapping procedure are relevant for pharmaceutical manufacturing. However, continuous scientific and technical development, as well as automation of equipment requires the development and implementation of the mapping process into the CT process. Temperature mapping is carried out through a number of requirements, which are partially mentioned in various guidelines on the quality of medical products and the operation of freezing equipment at CTS – guidelines of good practices: Good Clinical Laboratory Practice (GCLP), Good Manufacturing Practice (GMP), Good Storage Practice (GSP), Good Distribution Practice (GDP) and Good Automated Manufacturing Practice (GAMP). The latest 2012th edition of the International Society for Pharmaceutical Engineering (ISPE) GAMP–5 is a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. All of these good practices establish the mapping procedure as a required part of the operational and performance qualifications of the freezing equipment used to store drugs in manufacturing, storage facilities and during their transportation, particularly as a part of the “cold chain”. As far as properly calibrated freezing equipment is used during the CT, mapping can also be considered as part of the qualification in a regulatory procedure at CTS. We have developed SOP, which determines the requirements and the algorithm for conducting the mapping procedure at CTS.

Conclusions. The current requirements of ISPE GAMP–5 pharmaceutical engineering indicate that mapping is an automated process that has several advantages over the manual data capturing of temperature fluctuations. The mapping process allows continuously recording and storing temperature values at a specified interval for several days using temperature sensors, as well as it helps: to assess the stability of freezers; to identify critical (cold and hot) zones with the largest deviations of the temperature from the acceptable operating range; to determine critical (control) points for the purpose of further installation of data loggers to control the maintenance of a given temperature regimen of freezers. Thus, temperature mapping reduces the risk of errors, eliminates the “human factor” during the temperature recording in the freezer, as well as mobilizes the work of CTS. Further studies will make a background of a single national mapping document that is necessary nowadays to minimize the risks of any participant of CT.


Keywords


quality of clinical research; clinical trial site; temperature–sensitive biosamples; storage control; equipment qualification; temperature mapping; data loggers; automated systems

References


ICH E6 (R2), EMA/CHMP/ICH/135/1995. (2017). Guideline for Good Clinical Practice, 30–31. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r1-guideline-good-clinical-practice_en.pdf

The United States Pharmacopeia: Chapter 1079. (2017). Good Storage & Shipping Practices, 4–6. Available at: http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1079.html

Temperature mapping of storage areas. (2015). Technical supplement to WHO Technical Report Series, № 961, 5. Available at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/supplement_8.pdf?ua=1

Qualification of temperature–controlled storage areas. (2014). Technical supplement to WHO Technical Report Series, № 961, 22–25. Available at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/supplement_7.pdf?ua=1

Likarski zasoby. (2009). Nalezhna laboratorna praktyka: nakaz MOZ Ukrainy vid 16.02.2009 r. № 95. Ministerstvo okhorony zdorov’ia Ukrainy. Kyiv: MOZ Ukrainy, 22. Available at: http://webcache.googleusercontent.com/search?q=cache:kGNx6RmL8c0J:www.dec.gov.ua/site/file_uploads/ua/new_doc/nlp.doc+&cd=1&hl=ru&ct=clnk&gl=ua

Likarski zasoby. (2011). Nalezhna vyrobnycha praktyka: nastanova 42–4.0:2016. Ministerstvo okhorony zdorov’ia Ukrainy. Kyiv: MOZ Ukrainy, 110, 115. Available at: http://aipm.org.ua/wp-content/uploads/2016/08/GMP_42-4.0_2016.pdf

Likarski zasoby. (2011). Nalezhna praktyka zberihannia: nastanova 42–5.1:2011. Ministerstvo okhorony zdorov’ia Ukrainy. Kyiv: MOZ Ukrainy, 7. Available at: http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97%D0%9D%D0%9F%D0%97.pdf

Likarski zasoby. (2014). Nalezhna praktyka dystrybutsii: nastanova 42–5.0:2014. Ministerstvo okhorony zdorov’ia Ukrainy. Kyiv: MOZ Ukrainy, 11,12. Available at: https://www.apteka.ua/article/287944

Lalasa, P., Vishal Gupta, N., Raghunandan, H. V., Palleti Lakshmi Prathusha, Kailash Athkuri. (2012). A Review on applications of GAMP–5 in Pharmaceutical Industries. International Journal of Drug Development and Research, 5(3), 4–16.

WHO. (2018). Public Inspection Report Bio–Equivalence Study of Clinical Research Site Clinical Diagnostic Centre of National University of Pharmacy (NUPh CDC). Available at: https://extranet.who.int/prequal/sites/default/files/WHOPIR_NUPh-CDC12-16March2018.pdf

ISPE Good Practice Guide. (2011). Cold Chain Management, International Society for Pharmaceutical Engineering (ISPE), 69–89. Available at: https://ispe.org/publications/guidance-documents/good-practice-guide-cold-chain-management

Model Guidance for the Storage and Transport of Time– and Temperature–sensitive Pharmaceutical Products. (2011). WHO Technical Report Series, № 961, 341–342, 349–350. Available at: http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf

PDA: Technical Report 52: Guidance for Good Distribution Practices (GDPs). (2011). For the Pharmaceutical Supply Chain, 4–8. Available at: http://store.pda.org/tableofcontents/tr52_toc.pdf

PIC/S. (2014). Guide to good distribution practice for medicinal products, 11. Available at: https://www.npra.gov.my/images/seranta/2017/gdp/DRAFT_GUIDELINE_ON_GDP_3rd_Edi_2018_31102017.pdf

Most Popular Data Logger Types. (n.d.). CAS Data Loggers. Available at: https://www.dataloggerinc.com

ISO/IEC 17025. (2005). General Requirements for the Competence of Testing and Calibration Laboratories, 16. Available at:

https://www.sis.se/api/document/preview/922807/


GOST Style Citations


1. ICH E6 (R2), EMA/CHMP/ICH/135/1995: Guideline for Good Clinical Practice. – 2017. – P. 30–31. [Електронний ресурс]. – Режим доступу : https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r1-guideline-good-clinicalpractice_en.pdf


2. The United States Pharmacopeia: Chapter 1079: Good Storage & Shipping Practices. – 2017. – P. 4–6. [Електронний ресурс]. – Режим доступу : http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1079.html


3. Temperature mapping of storage areas. Technical supplement to WHO Technical Report Series, № 961. – 2015. – P. 5. [Електронний ресурс]. – Режим доступу : https://www.who.int/medicines/areas/quality_safety/quality_assurance/supplement_8.pdf?ua=1

 

4. Qualification of temperature–controlled storage areas. Technical supplement to WHO Technical Report Series, № 961. – 2014. – P. 22–25. [Електронний ресурс]. – Режим доступу : https://www.who.int/medicines/areas/quality_safety/quality_assurance/supplement_7.pdf?ua=1


5. Лікарські засоби. Належна лабораторна практика: наказ МОЗ України від 16.02.2009 р. № 95 / Міністерство охорони здоров’я України. Офіц. вид. – К. : МОЗ України, 2009. – С. 17, 22. [Електронний ресурс]. – Режим доступу : http://webcache.googleusercontent.com/search?q=cache:kGNx6RmL8c0J:www.dec.gov.ua/site/file_uploads/ua/new_doc/nlp.doc+&cd=1&hl=ru&ct=clnk&gl=ua


6. Лікарські засоби. Належна виробнича практика: настанова 42–4.0:2016 / Міністерство охорони здоров’я України. Офіц. вид. – К. : МОЗ України, 2011. – С. 110, 115. [Електронний ресурс]. – Режим доступу : http://aipm.org.ua/wpcontent/uploads/2016/08/GMP_42-4.0_2016.pdf


7. Лікарські засоби. Належна практика зберігання: настанова 42–5.1:2011 / Міністерство охорони здоров’я України. Офіц. вид. – К.: МОЗ України, 2011. – C. 7. [Електронний ресурс]. – Режим доступу : http://dls.gov.ua/wp-content/uploads/2019/02/%D0%9D%D0%B0%D1%81%D1%82%D0%B0%D0%BD%D0%BE%D0%B2%D0%B0-%D0%9B%D0%97%D0%9D%D0%9F%D0%97.pdf


8. Лікарські засоби. Належна практика дистрибуції: настанова 42–5.0:2014 / Міністерство охорони здоров’я України. Офіц. вид. – К. : МОЗ України, 2014. – С. 11, 12. [Електронний ресурс]. – Режим доступу : https://www.apteka.ua/article/287944


9. A Review on applications of GAMP–5 in Pharmaceutical Industries / P. Lalasa, N. Vishal Gupta, H. V. Raghunandan et al. // Intern. J. of Drug Development and Res. – 2012. – Vol. 5 (3). – P. 4–16.


10. WHO Public Inspection Report Bio–Equivalence Study of Clinical Research Site Clinical Diagnostic Centre of National University of Pharmacy (NUPh CDC). – 2018. – P. 17. [Електронний ресурс]. – Режим доступу : https://extranet.who.int/prequal/sites/default/files/WHOPIR_NUPh-CDC12-16March2018.pdf


11. ISPE Good Practice Guide: Cold Chain Management, International Society for Pharmaceutical Engineering (ISPE). – 2011. – P. 69–89. [Електронний ресурс]. – Режим доступу : https://ispe.org/publications/guidance-documents/good-practiceguide-cold-chain-management


12. Model Guidance for the Storage and Transport of Time– and Temperature–sensitive Pharmaceutical Products. WHO Technical Report  Series, № 961. – 2011. – P. 341–342, 349–350. [Електронний ресурс]. – Режим доступу : http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf


13. PDA: Technical Report 52: Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain. – 2011. – P. 4–8. [Електронний ресурс]. – Режим доступу : http://store.pda.org/tableofcontents/tr52_toc.pdf


14. PIC/S guide to good distribution practice for medicinal products. – 2014. – P. 11. [Електронний ресурс]. – Режим доступу : https://www.npra.gov.my/images/seranta/2017/gdp/DRAFT_GUIDELINE_ON_GDP_3rd_Edi_2018_31102017.pdf


15. Most Popular Data Logger Types // CAS Data Loggers. [Електронний ресурс] – Режим доступу : https://www.dataloggerinc.com (дата звернення: 22.09.2019). Назва з екрану.


16. ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories. – 2005. – P. 16. [Електронний ресурс]. – Режим доступу : https://www.sis.se/api/document/preview/922807/





Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

Abbreviated key title: Clin. pharm.

ISSN 2518-1572 (Online), ISSN 1562-725X (Print)