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Quality Control Training Modules - GMP Updated Training Modules文档
World Health Organization * * 7.7.1 Central store 7.7.1.1 Separate central storage facilities must be maintained for the secure storage of samples, retained samples (see Part Three. 18), and reagents, laboratory accessories (see Part Two. 10.7) and reference materials (see Part Two. 11). Storage facilities must provide the possibility to store material, if necessary, under refrigeration and securely locked-up. Access to be restricted to designated personnel. 7.7.1.2 The central store should be organized in such a way to accommodate incoming and outgoing samples, reagents, equipment, instruments and other devices. 7.7.1.3 Appropriate safety regulations must be drawn up and rigorously implemented wherever toxic or flammable reagents are stored or used. 7.7.1.4 Reagents subject to poison regulations or to the controls applied for narcotic and psychotropic substances must be clearly marked as "Poison". They must be kept separately from other reagents in locked cabinets. World Health Organization * * 7.7.1.5 The designated responsible member of staff must maintain a register of these substances. The head of each unit must accept personal responsibility for the safekeeping of any of these reagents kept in the workplace (see Part One. 6.5.1). 7.8 Archive facilities should be provided for the secure storage and retrieval of all documents (internally generated or from external sources), samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration. Access to be restricted to designated personnel. 7.9 Handling and disposal of wastes should be carried out as not to jeopardize the integrity of studies and environment. Provision of appropriate facilities for collection, storage and disposal should be available, as well as means of decontamination, where applicable, and transportation. 7.10 The environment in which the tests are undertaken must not invalidate the test results or adversely affect the required accurac
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