Registration standards process

The ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM provides guidelines to those involved in the development of quality system manuals and applicable standard operating procedures (SOPs) to comply with the requirements of international standard ISO 9001 2000 and proceed with the registration/certihcation process. The quality manuals (models) and SOPs provided in the CD-ROM are also a valuable tool for the companies to transform their existing ISO 9001, ISO 9002, and ISO 9003 quality manuals and SOPs to meet the requirements of revised standards. 

Objective This section describes the meaning of quality correspondence between ISO 9001 1994 and international standard ISO 9001 2000 and basic changes in ISO 9001 2000 international standard. It also provides a time line chart and documentation, and describes the registration/certification process. 

States and Canada, and the policies and needs of Western Europe, the Peoples Republic of China is only now in the process of developing registration standards and determining the role that toxicology will play in these standards. This symposium presents the differences and similarities between the United States, Canada, Western Europe, and the Peoples Republic of China as to toxicology and its role in pesticide registration. 

In doing this the problems may arise if one person alone manages several processes, i.e. if his activity embraces a number of functions (as may be especially typical for NDT). It is better if each process is assigned to a specialist responsible for it. For example, persons responsible for the technical state of NDT equipment, for metrological confirmation of NDT facilities, for standards on testing, for NDT results registration, etc. 

The method is based on the international standard ISO 4053/IV. A small amount of the radioactive tracer is injected instantaneously into the flare gas flow through e.g. a valve, representing the only physical interference with the process. Radiation detectors are mounted outside the pipe and the variation of tracer concentration with time is recorded as the tracer moves with the gas stream and passes by the detectors. A control, supply and data registration unit including PC is used for on site data treatment... 

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

The purpose of registration is to assess drugs for efficacy, safety and quality and to ensure that they are of an acceptable standard for use. When similar products are processed, the rates of registration approval and rejection reflect the ability of the registration system to prevent questionable products from gaining market access (3). 

ICH (1997). Technical Requirements for Registration of Pharmaceuticals for Human Use. Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals. S2B document recommended for adoption at step 4 of the ICH process on July 16, 1997. Federal Register 62 16026-16030, November 21, 1997. 

The pharmacopeias have worked with the ICH process to facilitate the international environment of pharmaceutical research and product registration. On the other hand, the additional situation for compendia is that the standards which they have published now apply to all of the already marketed products. In that case a company has testing history and product history in their quality control departments. These are the most conservative elements within the pharmaceutical industry as is necessary to their task. Quality control departments are reluctant to change methods when they feel that their products are properly represented by the current of tests. Therefore, a tension is ereated between trying to develop harmonized standards, which facilitate one area of activity in the world of pharmaeeutieals, and not disturbing a satisfactory marketplace. A vast amount of progress has been made in the harmonization of phar-maeopeial methods. 

III. Use of prevalidated and standardized packages Because software used in the regulated pharmaceutical industries is classified as medical devices it is possible for a vendor of a system to register that package under the Safe Medical Devices Act. The registration process includes submission of Copyright 2003 Marcel Dekker, Inc. 

The contents of the manual are divided into three major sections objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001 2000, and the process of documentation development and application for registration and certification. 

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