The quality control unit is responsible of control of quality of the manufacturing of fetal precursor cell transplants. It must be located in a building separate from manufacturing and its laboratory a self-contained entity. The duties of ‘Quality control’ are:
1/ To verify and approve conformance of actual production history of each batch as documented by appropriate manufacturing records with the established and approved written procedure protocols, with particular attention to the identity, strength, quality and purity of the final fetal precursor cell transplant.
2/ To carry out inspections of the closed colony of rabbits for conformance with standard operating procedures of that facility.
3/ To inspect the documentation of the environmental monitoring, of the calibration and maintenance of the equipment of the manufacturing facility, of the sterilization of equipment and supplies, and their conformance with written instructions.
4/ To release or reject raw materials, coming from reputable and regularly audited suppliers: tissue culture mediums, bovine fetal serums, washing solutions, antibiotics, antiseptics, etc., by inspecting the certificates thereof, and by sampling and testing of same as per written procedures.
5/ Release or rejection of tissue culture supplies, coming from reputable and regularly audited suppliers, e.g. Petri dishes, tissue culture flasks, vials, closures, containers, etc., by inspecting the certificates thereof, and by sampling and testing of same as per written procedures.
6/ Release or rejection of packaging and labeling materials.
7/ To inspect qualifications and training records of personnel, as well as records of their health examinations.
8/ To ensure adequate collection, identification and segregation of laboratory samples, acute or those stored in liquid nitrogen.
9/ To ensure accuracy of labeling and release records of released batches of fetal precursor cell transplants.
10/ To evaluate results of tests of quality of fetal precursor cell transplants by histological examination of tissue cultures at the time of the release of cell transplants.
11/ To evaluate results of bacterial sterility tests of fetal precursor cell transplants by inoculation of final supernatant of each culture flask onto fluid thioglycollate medium and soybean-casein digest medium.
12/ To evaluate results of bacterial endotoxin test.
13/ To maintain a procedures book describing all resposiblities and procedures of quality control unit.
14/ To investigate all instances when the supervising tissue culture expert ordered a tissue culture discarded for any reason, and to keep a written record thereof.
15/ To investigate all complaints from patients and physicians, particularly if they represent a serious adverse reaction and to keep a written record thereof.
16/ To review and approve validation protocols.
The manufacturing process for fetal cell transplants is validated by:
1/ standardization of methods of quality control;
2/ standardization of the conditions of quality control within the rules of GMP;
3/ standardization of tests used for quality control;
4/ standardization of all laboratories facilities, internal, and external;
5/ standardization of record keeping.