I. General Design Principles
The preparation of stem cell preparations should follow the basic principles of Good Manufacturing Practice (GMP)
II. Functional Partitions
1. p>1. Receiving sampling and distributing area: it should be isolated from the preparation area and have an independent clean environment, and the sampling operation of receiving should be carried out in Class A clean
environment.
2. Preparation and production area: set up a dedicated and independent preparation area, preparation facilities and equipment. Non-completely sealed state of the cell operation (such as separation, culture, filling, etc.) and direct contact with the cells can not be terminally sterilized reagents and appliances operation, should be carried out in a class B background of class A environment.
The preparation of reagents, the isolation, expansion and induced differentiation of stem cells, the preparation and filling or dispensing of stem cell preparations and other operations shall be carried out in separate areas within the clean area.
3. Quality control area: the preparation area shall be physically isolated, and the administrative area, living area and auxiliary area shall be free from obstruction to the preparation of stem cell preparations.
Each component of stem cells should meet the quality requirements of the current Chinese People's **** and National Pharmacopoeia;
Stem cells in different stages of the process (including cell banks) to develop the corresponding process control items and quality standards, including sterility, mycoplasma, internal and external sources of viruses, cellular identification, cellular viability and growth characteristics, cellular purity and homogeneity, cellular chromosomal karyotypes, biological Effectiveness, specific indicators of clinical indications, abnormal immunological response, endotoxin and tumorigenicity and other tests.
4, packaging area:
Packaging area should have enough space to ensure the orderly storage of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products to be examined, qualified, unqualified, returned or recalled, and other types of materials and products. Avoid confusion and cross-contamination of different products or materials, and avoid omissions or errors in production or quality control operations.
5, storage area:
The design and construction of the deep cryogenic storage library for stem cell preparations should ensure good storage conditions, the cryopreservation temperature should not be higher than -150 ℃, there should be ventilation and lighting facilities, as well as the necessary gas monitoring facilities.