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  • 1.  China, CFDA, inspections

    Posted 21-Jun-2018 11:34
    ​Hi RAPS Colleagues.
    Does anyone have experience with China (CFDA) manufacturing site inspections?
    Can you please help me with the following:
    1. How many investigators/auditors and normally onsite?
    2. How many days are inspections carried out?
    3. What is the inspection approach - combination of manufacturing walkthroughs, technical review of documents, interviews?
    4. Is it comparable with notified body audits (TUV, BSI), or FDA?
    5. Any general recommendations to be considered for site readiness?  Please advise.




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    Raymond Seda MBA, RAC
    Director, Quality and Regulatory Affairs
    Santa Isabel
    United States
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  • 2.  RE: China, CFDA, inspections

    Posted 22-Jun-2018 13:12
    Raymond, 
    See my answers to your questions below.  Please do not hesitate to reach out to us if you have further questions.  We are actually helping SDA (CFDA)developing their curriculum for field inspections.  The whole overseas/domestic inspection area at SDA (CFDA) is relatively new. 
    1. How many investigators/auditors and normally onsite? Usually 3 to 5: 1 or 2 experienced.  Rest are more learners.  We have a write up about it in our blog on our website www.ChinaMedDevice.com
    2. How many days are inspections carried out?  Usually a week. 
    3. What is the inspection approach - combination of manufacturing walkthroughs, technical review of documents, interviews? Both.  They have a set of documents and guidelines that they follow.  Depending on your products, there could different areas of focus.  I have had direct dialogues with the head of SDA Inspection about their approach and what is important to them. 
    4. Is it comparable with notified body audits (TUV, BSI), or FDA? The guidline is similar but how they do and what they process and the culture are different.  
    5. Any general recommendations to be considered for site readiness?  Please advise. Not easy to answer here.  You can email me and we can set up a call.  They do not speak English with you even though they may understand.  Everything has to be done in Chinese.  We can certainly help with the process, getting you ready including the translation and communication during the audit.


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    Grace Fu Palma
    China Med Device, LLC
    MA, U.S.
    gpalma@chinameddevice.com
    978-390-4453
    www.chinameddevice.com
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    Original Message


  • 3.  RE: China, CFDA, inspections

    Posted 26-Jun-2018 06:47

    Hello Raymond,

    At Qserve Group we have an office in China and we have a team of CFDA experts, most of them are Chinese-speaking and couple of them have trained the CFDA inspectors on how to conduct the overseas inspection. Over the last couple of years, we have conducted several CFDA mock inspections to companies in the US that have gotten the CFDI inspection notice.

    1.       Number of auditors varies. The minimum is 2, but we are used to see 4. The auditors team are made of a combination of experienced auditors and newly trained ones. Also there is usually a product exert part of the audit team.

    2.       The inspection is usually for a week, so if you get the typical number of auditors (4), that means 20 man-days.  So you can imagine every areas of the GMP is audited generously in the typical 5 days audit. CFDA inspectors are known to work in parallel to each other but they are always in the same audit room.

    3.       The audit approach is all you mentioned plus the fact the CFDA can sample your product and ask you to ship it to China for confirmatory testing. Also, CFDA inspectors can collect objective evidence by photocopying or taking pictures and other methods. There are ways to get around this, or have it done but still under your company policy. The key is you have to show them respect and your full cooperation in the audit as uncooperative circumstances such as obstructing, limiting or refusal to collect the objective evidence can result in a "fail" conclusion of the audit.

    4.       CFDA inspection type cannot be compared to NB or FDA audits for many reasons. The regulations themselves though may read very similar, they stem from Pharma GMP. So for example, the ISO approach is always "processes input, output, etc.", while for the CFDA is "you must do X way"…there is no room for creativity with some of the requirements to be GMP compliant. Also one big difference is the audit conducted in Chinese and the manufacturer is responsible to provide the translators and responsible for any translation error.  

    5.        Few tips to prepare for on-site inspection:

    a.       Just as you prepare of any audit, identify your SMEs. Be sure they understand the procedures well in English to be able to load the info requested in smooth and timely manner to the translators.

    b.       Identify who your translators are going to be. We normally recommend folks with RA &QA background. Both your English-speaking SME and translators must become very familiar with the GMP requirements and PRACTICE.

    c.       Allow for back-up translators due to fatigue, etc.

    d.       Ensure your PTR are up-to-date, and all design changes have been implemented in the current PTR available on -site as inconsistencies between the product sold on market today and the registration dossiers can lead to fail conclusion of the audit.

     

    Please do not hesitate to contact me or Qserve Group  if you need support with CFDA inspection readiness.

    Best regards,

    Rania

    http://www.qservegroup.com/



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    Rania Gerges
    http://www.qservegroup.com/

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    Original Message


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