Pharmaceutical information systems

The Expert Report is a particular requirement of the European pharmaceutical regulatory system. It is intended that the Expert Report submitted by the applicant should include an accurate summary of the supporting evidence for the application and that it should also include a critical discussion of that information. Expert reports were originally required when a requirement for an Assessment Report was imposed on the member states the intention was that the Expert Report should form the basis for that Assessment Report. 

Development pharmaceutics information is intended to cover a number of aspects related to the active ingredient(s), excipients, container-closure system, and the finished (drug) product. These aspects will be considered individually below. 

The ABPI Code of Practice, in line with European Directive 75/319/EEC, calls for an efficient transfer of information on adverse drug reactions. In the case of defective medicines, an ABPI Batch Recall of Pharmaceutical Products system is in operation. In the ABPI Expanded Syllabus, batch recall is referred to in the Pharmaceutical Technology section and adverse drug reactions in the Pharmacology and Classification of Medicines and the Pharmaceutical Industry and the NHS sections. 

FIGURE 9 Simulation network for distributed pharmaceutical manufacturing systems and their warehouses in U.S., Europe, India, and Asia. Model focuses on information and data management, the way the servers can cope with the task of tracking pharmaceutical product, and RFID data on a world wide basis. As a modeling tool we use OPNET, a professional network simulation tool. 

H. Matuoka, H. Shimizu, S. the 14th Kyushu Branch meeting of the Pharmaceutical Society of Japan, 1997. Paper 2B-21 Japan Science and Technology Corporation Online Information System (http //www.jst.go.jp/EN/). CN99A0129771. 

Although I have published several scientific articles throughout my academic career spanning 15 years, this is my first book. I consider it both an opportunity to share my experience of developing chemical information systems for the pharmaceutical industry and an opportunity for me to learn. Therefore, I do not expect this book to be perfect. I welcome feedback from the readers so that I can improve on the material for my next book. 

Pharmaceutical organizations are increasingly looking to information systems to maintain the vast volumes of information that support modem research and manufacturing operations. 

The cost of validation is much publicized as is the debate regarding the extent to which information systems should be validated. Validation is essentially the term adopted by the pharmaceutical industry and their regulators to define the additional rigor required to confirm GxP critical aspects of information systems throughout the development and operational life of those systems. Given that pharmaceutical regulators have the power to withhold, suspend, or withdraw product licenses. 

Processes used to determine functional criticality, such as FMEA, have already been discussed within this chapter. Similarly, FMEA and other risk assessment tools can be used to determine the scope of validation. The risk of failure increases as information systems supporting the EMS strategy deviates from a standardized solution that is, the level of tailored development increases. In addition, the extent to which a product is utilized within industry, in particular pharmaceuticals, must be taken into consideration when determining the scope of validation. 

Earger chemical and pharmaceutical firms have, over the years, developed in-house systems with capabilities that are specific to the chemist s needs. Today, the costs of developing from scratch and maintaining an in-house system are prohibitive, especially because commercial chemical information systems are highly efficient and customizable. Personal chemical information software is still being developed and reported in the literature. Examples include a relational database patterned after the Upjohn Cousin system (108), and CheD, which is a SQL-based system with a Web client (109). 

All those with an interest in the pharmaceutical sciences need up-to-date and reliable drug information, not only for their own research and studies, but also for communicating with their healthcare colleagues and patients. In this chapter, we will discuss the wide range of modern electronic drug information systems that are currently available, and will give an indication of their main uses and individual strengths. 

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