Regulatory Open Forum

Hi RAPS community,

I was hoping that some of you could share their experience with Korea Food And Drug Administration (KFDA) inspection of contract manufacturers based in the USA. In particular:

- How the auditors and their expectation differ from FDA’s approach?
- What areas did they focus on?
- Were there any unique expectations or interpretations?
- What areas did they glance over?

Your help would be very much appreciated.

Regards,

Hi RAPS community,

I was hoping that some of you could share their experience with Korea Food And Drug Administration (KFDA) inspection of contract manufacturers based in the USA. In particular:

- How the auditors and their expectation differ from FDA’s approach?
- What areas did they focus on?
- Were there any unique expectations or interpretations?
- What areas did they glance over?

Your help would be very much appreciated.

Regards,

Also, the inspection team didn't speak much English (or so they said :-)), so the company's Korean distributor came with them and served as translator.  Not a good idea...distributors have their own agendas.  If no one at your company speaks Korean (very, very well), secure the services of a translator for the duration.

Hi RAPS community,

I was hoping that some of you could share their experience with Korea Food And Drug Administration (KFDA) inspection of contract manufacturers based in the USA. In particular:

- How the auditors and their expectation differ from FDA’s approach?
- What areas did they focus on?
- Were there any unique expectations or interpretations?
- What areas did they glance over?

Your help would be very much appreciated.

Regards,

The KGMP inspection is based on ISO 13485. Some missing areas would be as mentioned by Julie, that they are particular to update the Quality Manual reference to KGMP/Medical device regulations of MFDS-Korea.

I have attached the audit checklist template for your information.

The other factors to consider include:

- the total number auditors would be 1 to 3, either from a 3rd Party and/or from MFDS, depending upon risk classification of the product, number of products under the audit (shipped to Korea) and size of the manufacturing site

- usually the audit would be for 4 days

- the KGMP cert holder is the Korean Distributor/Importer. As per the  MFDS regulations, the cost for the KGMP Inspection should be borne by the local distributor/importer. 

-The cost includes air fare, accommodation and food (also from a culture perspective, they expect you to take them(auditor) for dinner outside for all four days or sight-seeing)

- As Julie mentioned, either you need to arrange for a translator or ask your Korean distributor to send one from Korea

Hope this helps!

Regards,

Sreenu

Also, the inspection team didn't speak much English (or so they said :-)), so the company's Korean distributor came with them and served as translator.  Not a good idea...distributors have their own agendas.  If no one at your company speaks Korean (very, very well), secure the services of a translator for the duration.

Hi RAPS community,

I was hoping that some of you could share their experience with Korea Food And Drug Administration (KFDA) inspection of contract manufacturers based in the USA. In particular:

- How the auditors and their expectation differ from FDA’s approach?
- What areas did they focus on?
- Were there any unique expectations or interpretations?
- What areas did they glance over?

Your help would be very much appreciated.

Regards,

I would like to share my experience.

Our company is based in Tokyo, Japan.  One of our contract manufacturer of IVD in Japan received their KGMP inspection in June.  So, the situation is similar with yours.  Since design development is done by our company, they spent 3 days at the contract manufacturer and 1 day at our company.

The number of inspector is 1 or 2 depend on the risk classification.  They usually focus on the product which is higher risk and most sold in Korea.  If such a product is class III, 2 inspectors (1 from MFDS, 1 from the 3rd party notified body such as KTC) come to inspection.  If the product is class II, 1 inspector from the 3rd party notified body comes.

Their inspection is basically based on ISO 13485.  They looked at closely the relationship between our company and the contract manufacturer including the contract (supply agreement).  They reviewed the tech transfer and the result of the manufacturing process validation closely.  They also reviewed the Quality Manual for both companies.  I think that their inspection style is similar to that of US FDA from my experience of pharmaceutical area.

The most important thing is to have a good interpreter.  It's worthwhile spending money on interpreters.

Response to the observations is expected in 30 days.  If further question to the1st response comes, you have 10 days to respond.  If you cannot respond in 10 days, you have to submit request for extention, otherwise, your inspection fails.

I hope this helps.

Toru

Hi RAPS community,

I was hoping that some of you could share their experience with Korea Food And Drug Administration (KFDA) inspection of contract manufacturers based in the USA. In particular:

- How the auditors and their expectation differ from FDA’s approach?
- What areas did they focus on?
- Were there any unique expectations or interpretations?
- What areas did they glance over?

Your help would be very much appreciated.

Regards,

As pretty much everyone else has said, having a good translator is hugely important. The last KFDA inspection I experienced had a number of challenges due to "lost in translation" problems. Remember too that the translation process adds time and pauses, and use them wisely. The inspectors we had were somewhat more focused on "classic GMPs" than quality systems (though they touched on all). For instance, they got very hung up on having CofC for all suppliers and from our company to distributors. Additionally they spent a huge amount of time on sterilization, microbiology etc.There were a lot of tedious and frrustrating moments, particularly when they seemed to expect certain words to be in contracts or documents - make sure your front room folks are super-patient.

g-

Hi RAPS community,

I was hoping that some of you could share their experience with Korea Food And Drug Administration (KFDA) inspection of contract manufacturers based in the USA. In particular:

- How the auditors and their expectation differ from FDA’s approach?
- What areas did they focus on?
- Were there any unique expectations or interpretations?
- What areas did they glance over?

Your help would be very much appreciated.

Regards,