ABSTRACT
According to EDQM, establishments performing very simple, minimal manipulation of a limited range of tissues and cells in accordance with published methods, or following long-established practices using the same materials and equipment, may rely on ongoing quality control and periodic reviews. Change control is a systematic approach that is used to ensure that any intended modification to the process, equipment, instruments, facility, and so on, is introduced in a coordinated manner and to reduce the possibility that unwanted or unnecessary changes will be introduced into the culture system. If the ambient relative humidity and temperature of the cleanroom environment exceeds 50% and 25°C, the risk of bacteria growth increases. For quality control purposes, the pH of each batch of culture medium should be measured after proper pre-equilibration and should be within the range specified on the certificate of analysis.
