**Author details**

*Biochemical Testing - Clinical correlation and Diagnosis*

**6.2 Approach to validation**

refrigerator-freezer). Systems, installations, or devices for which PQ activities are necessary will be selected at the risk analysis (RA) stage. Any noncompliance with the conditions set out in the protocols encountered during the validation process will be recorded and evaluated. The registered nonconformities will be analyzed, and then the actions regarding the manner of further dealing with the nonconformities (e.g., the development of justification/explanation, making corrections, and then carrying out reclassification tests) will be defined. All such data will be documented and saved. The obtained results will be collected and presented in

Validation of rooms, devices, systems, and installations used in production carried out in the tissue bank constitutes a part of the quality assurance policy of the entire enterprise (tissue bank, hospital, and biotechnological or pharmaceutical company). Qualification/validation activities and the creation of appropriate documentation must be carried out in accordance with the qualification/validation schedule by tissue bank representatives, suppliers of installations, systems, process equipment, and/or contractors providing validation services. Supervision and coordination of qualification/validation activities should be carried out by a tissue bank representative. Validation teams and validation contractors are required to develop a series of protocols to check all critical parameters of rooms, systems, installations, and devices in the tissue bank. The protocols will be implemented in accordance with the test methods presented in the protocols. Each protocol will be used to obtain documentation that will confirm the compliance of the system, installation, or device with the GMP guidelines. To qualify equipment, rooms, and installations, the documents obtained after carrying out the service activities can be used. All

It should be emphasized that conducting validation cannot negatively affect the production process. In addition, special attention should be paid to the timely performance of validation work, and subsequent planned validation activities related to a given device, room, etc., should be carried out within the prescribed time limit. However, it is possible that the deadline of the next validation is not met. This disadvantageous situation may occur due to a number of possible occurrences that may affect the feasibility of performing validation work. The factors affecting the performed validation work time shift include, among others, production, sickness of the person performing the validation, mechanical failure, etc. The information

In order to summarize and approve the completion of individual stages of qualification/validation activities, appropriate reports are prepared, which are checked and approved by appropriate persons. The report must include a summary of the qualification/validation course, a description of test results, and documented, explained, and evaluated nonconformities. After the approval of the report, if no critical nonconformities were found or all critical nonconformities were resolved,

The activities related to the performance of validation/qualification activities are aimed at ensuring the highest quality of the tissue bank products being developed. They take place in accordance with RBV and with the optimal use of the strategic potential of the laboratory. The approach to validation is part of the broadly understood RBV, which results from the conscious management of the unit using

relevant reports after the completion of each qualification stage.

protocols and reports will be archived after their final approval.

about the validation time shift must be included in the validation protocol.

you are allowed to proceed to the next qualification/validation phase.

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**6.3 Summary**

Wojciech Smętek1 \*, Jacek Węgrzyk1 , Agnieszka Klama-Baryła1,2, Wojciech Łabuś1 , Małgorzata Kraut1 , Michał Szapski1 , Mariusz Nowak1 and Diana Kitala1,2

1 Stanislaw Sakiel's Center for Burn Treatment, Siemianowice Śląskie, Poland

2 Silesian Higher Medical School in Katowice, Katowice, Poland

\*Address all correspondence to: fundusze@clo.com.pl

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
