1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

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.

Tags:
  1. Rick Schellenberg

    Rick Schellenberg Member

    Joined:
    Nov 25, 2019
    Messages:
    5
    Likes Received:
    0
    Trophy Points:
    1
    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
     
    Rick Schellenberg, Jan 8, 2020
    #1
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,411
    Likes Received:
    2,690
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    I'd always start with the basics: ISO 9001
     
    Andy Nichols, Jan 8, 2020
    #2
    Rick Schellenberg likes this.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,411
    Likes Received:
    2,690
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    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).
     
    Andy Nichols, Jan 8, 2020
    #3