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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

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7.5.2 The manufacturer shall validate any processes for production and service provision w...

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7.53.3 Status identification The manufacturer shall identify the product status with respe...

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The manufacturer shall maintain records of the process parameters for the sterilization pr...

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(e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eat...

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4. Quality management system 4.1 General The manufacturer shall establish, document, imple...

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

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Illustration: Anticoagulant monitoring, diabetes management, and testing for C-reactive pr...

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The National Pharmaceutical Pricing Authority (NPPA) is a regulatory body responsible for ...

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