Cryobiology and Cryotechnology

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Blood products for transfusion in Japan are regulated by the pharmaceutical affairs law enacted by the Ministry of Health and Welfare. The quality system of GMP regulation for pharmaceutical products was introduced in 1976 and was applied for blood centers and blood products. GMP consists of the regulation for facilities and equipment (GMP hard), and quality management (GMP soft). The aims of GMP are prevention of human errors, prevention of contamination and quality defect of drugs, and constitution of quality system for manufacturing high quality pharmaceutical products. GMP contains GMP system, standard documents, management of manufacture, quality control, calibration, validation, management for complaints and recall, internal audit, and educational training. Blood centers in Japan have just started to use GMP and they look to be behind to other pharmaceutical companies particularly in the respect of GMP Soft. Therefore, we have to promote activities for carrying out GMP especially in quality management.

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Recent progress in recombinant DNA technology and cell culture technology has enabled us to produce new medically useful agents for gene therapy and cellular therapy. To enable these products to be of use in human therapy, it is essential that suitable measures be taken by the manufacturers and control authority to assure quality, efficacy, and safety. This article describes points, based on the latest sound scientific principles, to be considered for producing, testing, evaluating and controlling pharmaceutical products for gene therapy and cellular therapy, especially with respect to their quality and safety.

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Since an Investigational Drug GMP started on April 1st, 1997, in Japan, process validation for clinical pharmaceuticals production has become to be required. Guideline on sterile drug products by aseptic processing includes ensuring of equipment suitability, water control, cross-contamination control, environmental monitor and media-fill trials. This report is concerned with process validation in our clinical pharmaceuticals plant.

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Recent topics on freeze-dried drugs have been reviewed. Points to comply with GMP requirements and with official requirements for product quality are also discussed from viewpoints of freeze-drying systems. Emphasized is the importance of preferentially collecting information important and useful to handling the system. Foreign matter contamination of freeze-dried products is briefly discussed. Conclusively, co-operation of drug manufactures with system-manufactures, authorities, and academic groups concerned will surely enhance the quality level of freeze-dried products.

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