Search results for "iso17025 vs gmp"

Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Assign topic to the user

  • Equipment qualification

    I come from a cGMP background so DQ/IQ/OQ/PQ is standard for all equipment, but now I'm trying to set up an ISO 17025 compliant lab and am not sure if I need to do the same qualification. Would calibration and verification to make sure the equipment is functioning (using a lab developed reference standard, if CRM is not available) suffice?
  • Perform an audit using ISO 17025 guidelines

    I am a quality manager and i have to perform an internal audit using the guidelines of iso17025:2017. Do you have any guidelines and tips to excel in this audit?

  • Differences between ISO 13485:2003 and ISO 13485:2016

    1. What are the exact differences between ISO 13485:2003, ISO 13485:2016?

    2. What portions of FDA cGMPS, are being revised to comply with ISO 13485:2016?

  • Using Non-ISO Clients on Controlled Forms

    I have a PhD and have been creating/building/working in an ISO17025 laboratory for over 30 years. Today, I was helping a fellow company with an internal audit. On one of the ISO controlled forms I noticed that full names of companies have been completely spelt out (process deficiency, confidentiality deficiency). The lab manager (not very experienced) said that because those non-ISO clients are on an ISO form, they don't count for confidentiality and process rules under ISO. Shocked, I didn't know what to say. Is it a documentation deficiency to list non-ISO clients on ISO internally controlled documents?

  • ISO 17025 in pharmaceutical industry

    I would like a brief overview of the linkage of ISO 17025 and GMP
  • Questions about ISO 13485 implementation

    My company (a contract manufacturer) will, in the near future, be manufacturing and distributing (and exporting) medical devices alongside products not classified as medical devices.  We were advised to implement the Good Manufacturing Practice (GMP) and the Good Distribution Practice For Medical Devices (GDPMD). I would be very grateful if you could advise me on the following matters:

    1) Is it a requirement for the medical device outsourcing company to have implemented ISO 13485 before my company implements GMP?

    2) If the outsourcing company (who owns the product label or brand name) fails in being ISO 13485 compliant,  should my company then implement ISO 13485 instead of GMP?

    3) In doing my research for my company, I noticed that GMP and GDPMD have certain similar mandatory document requirement – e.g. the Quality Manual, SOP on Document Control, SOP on Pest Control, SOPs on Internal Audit and Management Review. Instead of having duplicate documents, could such documents be adapted to accommodate both GMP and GDPMD? For instance, drafting one Quality Manual that caters for both GMP and GDPMD?  

    4) Should the scope of the GMP include the other products (not technically defined as medical devices) manufactured and distributed by my company, or could it be limited to the medical products only?

    Thanking you in anticipation of your kind response to my above questions.

    Note: It is by chance that I came across Advisera’s publications in the web, and I found them to be very insightful. Keep up the good work.

  • Can aflatoxin be accredited using ELISA?

    can aflatoxin be accredited using ELISA? for an ISO17025 accredited lab

  • Auditing impartiality

    How do you audit impartiality, how do you ensure impartiality in a testing laboratory according to ISO17025:2017?
  • ISO/IEC 17025:2017 accreditation timeline

    ... nt of time before lab is operational to get application data submitted and then some amount of time after lab is operational to validate procedures, processes, etc. and then finally third party validation. Is this a fair assessment? Any help would be much appreciated. Other recommendations? I noticed that the site mentions familiarity training. Are you all an approved certified body for ISO17025 audits?

  • Audit Non-conforming work

    Asking about ISo17025:2017 clause 8.2.2 how to implement in a laboratory?
Page 4 of 122 pages

Didn’t find an answer?

Start a new topic and get direct answers from the Expert Advice Community.

CREATE NEW TOPIC +