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Subject: documentation of performance of the testing sampling plan and number of replicates to be pharm. Handling Out of Specification (OOS) ResultsOOS results are investigated by the Quality Division in order to draw appropriate conclusions regarding the product being tested and to implement any necessary corrective actions. Investigation includes, as relevant: review of the manufacturing batch record to determine if there were any deviations in the process that could account for the OOS result; determination if additional testing is justified and documentation of performance of the testing sampling plan and number of replicates to be tested.. Помогите, пожалуйста, перевести последний пункт - |
| ...дополнительных испытаний и документальное подтверждение осуществления плана отбора проб и количества параллельных образцов, предназначенных для тестирования. |
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