(e) the name, description and batch number of the sample where appropriate; (f) the name and address of the original manufacturer and, if applicable, those of the repacker and/or trader; (g) the reference to the specification used for testing the sample; (h) the results of all tests performed (mean and standard deviation, if applicable) with the prescribed limits; (i) a conclusion as to whether or not the sample was found to be within the limits of the specification; (j) expiry date or retest date if applicable; (k) date on which the test(s) was (were) completed; and (l) the signature of the head of laboratory or other authorized person. Note : The Guideline on model certificate of analysis was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its thirty-sixth meeting ( 3 ). 20. Retained samples 20.1 Samples should be retained as required by the legislation or by the originator of the request for analysis. There should be a sufficient amount of retained sample to allow at least two re-analyses. The retained sample should be kept in its final pack. Part four. Safety 21. General rules 21.1 General and specific safety instructions reﬂecting identified risk, should be made available to each staff member and supplemented regularly as appropriate (e.g. with written material, poster displays, audiovisual material and occasional seminars).
120 21.2 General rules for safe working in accordance with national regulations and SOPs normally include the following requirements: (a) safety data sheets should be available to staff before testing is carried out; (b) smoking, eating and drinking in the laboratory should be prohibited; (c) staff should be familiar with the use of fire-fighting equipment, including fire extinguishers, fire blankets and gas masks; (d) staff should wear laboratory coats or other protective clothing, including eye protection; (e) special care should be taken, as appropriate, in handling, for example, highly potent, infectious or volatile substances; (f) highly toxic and/or genotoxic samples should be handled in a specially designed facility to avoid the risk of contamination; (g) all containers of chemicals should be fully labelled and include prominent warnings (e.g. “poison”, “ﬂammable”, “radioactive”) whenever appropriate; (h) adequate insulation and spark-proofing should be provided for electrical wiring and equipment, including refrigerators; (i) rules on safe handling of cylinders of compressed gases should be observed and staff should be familiar with the relevant colour identification codes; (j) staff should be aware of the need to avoid working alone in the laboratory; and (k) first-aid materials should be provided and staff instructed in first-aid techniques, emergency care and the use of antidotes. 21.3 Protective clothing should be available, including eye protection, masks and gloves. Safety showers should be installed. Rubber suction bulbs should be used on manual pipettes and siphons. Staff should be instructed in the safe handling of glassware, corrosive reagents and
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- Summer '17