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What is an appropriate Quality Standard for Pharmaceutical Equipment Manufacturers?

Discussion in 'Pharmaceuticals (21 CFR Parts 210 & 211)' started by Rick Schellenberg, Jan 8, 2020.

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  1. Rick Schellenberg

    Rick Schellenberg Member

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    For a company designing, producing, and selling measurement instrumentation for pharmaceutical companies, what quality standard is recommended as a minimum? ISO 9001? GMP? Something else? Or does it matter as long as one has a defined quality system with policies and procedures? Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd always start with the basics: ISO 9001
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Rick: If the scope of your QMS - from your consideration of the section 4 "Context of the organization", has revealed that your "interested parties" see that offering repair and calibration, then that part of the business might opt for ISO/IEC 17025 accreditation. But I'd a) start with ISO 9001, then - once you understand the whole practical implications of the Context you can decide if b) implementing a calibration service to meet ISO/IEC 17025 is appropriate (which can heavily leverage your existing ISO 9001 QMS).
     

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