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(a) Laboratory data shall contain complete info derived from all assessments necessary to assure compliance with set up technical specs and requirements, including examinations and assays, as follows:e. GxP approach Handle, high-quality management and excellent audit options). The net document management application must also give the next features

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Working with this information and facts, compute the utmost volume dose per kg into a 70-kg human topic. For that rabbit pyrogen test, inject no less than ten occasions this dose for each kg of entire body weight into Every single rabbit. If necessary, dilute with Sodium Chloride Injection. The full injected volume for every rabbit is not really be

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