Recent progress in biotechnology, including recombinant DNA (rDNA) technology and cell culture technology, has enabled us to produce new medically useful agents intended for human use. These agents include therapeutic peptides and proteins derived from rDNA-modified cell substrates, continuous cell lines, diploid cell lines, and hybridoma cell lines, gene therapy products, cellular therapy products, and therapeutic protein products and cellular products derived from transgenic animals. To enable these products to be of use in human therapy, it is essential that suitable measures be taken by manufacturers and regulatory authorities to assure their quality, efficacy, and safety. This article describes points based on the latest sound scientific principles to be considered when producing, testing, evaluating and controlling biotechnological products for human therapy, especially with respect to their characteristics, quality and safety.

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  Bacterial spores, which are mainly produced by Bacillus and Clostridium in response to lethal environment, are well known as significantly dormant cell form. First, characterization of bacterial spores and preparation of them are briefly reviewed in this paper. Measurement of heat resistance issued in ISO is also described here. Because of their high resistance against chemical and physical treatments, sterilization of bacterial spores and valuation for sterilization methods should be considered. From this point, methods for sterilization and sterility tests concerning bacterial spores are partially modified or newly added in the recently issued JSP 14th edition, some of these items are briefly explained in this paper.

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  Present situation of Japanese pharmaceutical companies has been analyzed by various statistics, and compared with the situation in the world. The environment of pharmaceutical industries are rapidly changing in its structure, worldwide regulatory viewpoints, and the trend of globalization. (1) Out-sourcing or contract specialized business are emerging rapidly in every field of pharmaceutical industries, such as research and development, manufacturing and even in the field of sales and promotion, According to the emerging of such contract or specialized organization in each function of the industries, importance of quality unit should be emphasized as a key function which has the responsibility for the branded products. (2) How to make use of these specialized other functions would play an important role for the success of future pharmaceutical industry. (3) For the globalization of Japanese pharmaceutical industries, not only the development of new products, regulatory issues, patent, G“X”P, and relation with alliance would be important, since there have been so many Japanese industries who had experienced same kinds of problems in launching their product. (4) Foreign affiliated pharmaceutical industries in Japan, they are steadily progressing their business by introducing new products and sales promotion. (5) Generic products should be more widely used in Japan from the view points of cost effective medical treatment in comparison with other countries.

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  Three and half years have already passed since the publication of 21 CFR Part 11 by FDA in August 1997. Although the electronic signatures and records in Part 11 were at first recognized as somewhat stringent regulations for legislative measures, the Part 11 has now been regarded to allow most of all activities in the pharmaceutical industry to be reviewed. At this moment, the unbiased study in the current status of 21 CFR Part 11 seems to be meaningful for Japanese industries. Some important key points of 21 CFR Part 11 are also to be so well detailed that the latest activities of PDA and ISPE in Part 11 should be introduced with some compliance strategy proposed for the Japanese pharmaceutical industry.

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  Current plastic containers for solution type medicine have a problem in assessing the stability because of a decrease in water during strage, due to the moisture permeability of plastics. A lower humidity condition is selected in both the accelerated stability test and long-term storage stability test for the registration stability data. Thus, it is necessary to predict the water loss from the plastic containers in high accuracy in the development of primary plastic containers in the lower humidity condition. This study indicated that an application of material transfer dynamics using first order reaction equation is useful for the prediction of the water loss from the plastic containers in various storage conditions. When the ratio of apparent diffusion coefficient of water through the plastic container in the different two temperature conditions is available and data in one temperature/humidity condition is available, it is possible to calculate the water loss in the various storage conditions for the prediction. This prediction method may help the assurance level of the quality of development technology as well as container itself and stability evaluation of liquid type pharmaceuticals in plastic containers.

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