Ohayou Gozaimasu. An appropriate Japanese phrase for this week’s guidance is; “Doko ni sun de imasu ka?” For those of you moderately fluent in Japanese, the phrase is: “どこに住んでいますか？” The literal translation is “Where do you live?”

If during a PMDA inspection, the inspector whispers to the Chief Impalable Officer (CIO) “Doko ni sun de imasu ka” followed by the words, “I have a sword for you,” the CIO can assume the inspection is not going well. 

Dr. D likes to consider himself as a “factotum” (look-it-up) to the regulatory and quality community. The doctor very much enjoys writing, and hopefully entertaining the readers, while passing on some guidance and knowledge in the process. For you know-it-alls out there, the topic of regulatory affairs and quality assurance can be extremely boring and mundane. Discussing regulations does nothing more than amplify the level of boredom. However, we are in the medical device industry; and in the medical device industry compliance to regulations is a salient requirement. That being said, training (regardless of regulatory environment) is one of the cornerstones of an effective quality management system. In this edition of DG, the doctor will take a final look at training as it impacts combination devices, with a component of biological origin, sold into the Japanese device market. 

Ministerial Ordinance Number 169 (2004)

What device manufacturers need to know

This week’s guidance starts with the reinforcement of the need for well-written procedures that device manufacturers actually follow. Yes my friends, a novel concept here, procedures actually need to be followed; otherwise, what is the point? Earlier in this series Dr. D explored training from the perspective of a general requirement typical of ISO 13485. Article 77 is considerably more specific. If a device manufacturer and/or its supplier(s) of material of biological origin maintain a small petting zoo for testing purposes, the expectation is that an individual in the organization be trained in veterinary medicine. Now the doctor is not saying that every manufacturer of a device with a component of biological origin needs to retain Dr. Doolittle; however, Article 77 clearly states that a trained Dr. Doolittle-type individual is required. Article 77 also requires organizations to train and retain microbiologists, individuals with a medicinal background (that doesn’t mean heavily medicated) and a blacksmith for keep the CIO’s sword sharp (just kidding about the blacksmith).

All personnel working in an aseptic environment (cleanroom) must also be appropriately trained. This means engineers, assemblers, inspectors, janitors, etc. need to be trained to prevent contamination associated with handling microorganisms. Dr. D is not a microbiologist so all the doctor can say is that, “dude, germs are bad things man!” Seriously, a significant amount of caution must be exuded when handling pathogenic microorganisms in an aseptic environment. Dr. D cannot place enough emphasis on the handling and controls required to prevent cross-contamination of products.  

What device manufacturers need to do

I know the doctor is beginning to sound like that proverbial broken record; however, well-written procedures are needed to support organizational training. This includes the collection and retention of training records, a.k.a., “documented evidence.” Now depending on the size of the medical device manufacturer, there may not be a dedicated resource for training. Guess what? That is not a viable excuse for not training personnel. There are dedicated training organizations out there like the Hintz Training Group (no, Dr. D is not a paid spokesperson for this group) that can perform the task of training.  

Similar to 21 CFR, Part 820 requirements, MO 169 requires evidence of training. Sitting across from a PMDA inspector is no different than sitting across from the FDA, when the CIO has to defend not having objective evidence of training. The big difference is, the FDA pulls out a pen and writes a Form 483 observation, while PMDA pulls out a sword and hands it to the CIO to fall on (just kidding).  As you can quickly garner from Table 1.0, Article 77, although more specific in nature, maps nicely to ISO 13485 and 21 CFR, Part 820.

Table 1.0 – Sample Requirements Matrix
Procedure(s)	Procedure Name(s)	Requirement	21 CFR, Part 820	EN ISO 13485:2012	MHLW MO 169
1247-1 Rev C	Competence, Awareness, & Training	Training	820.25	6.2.2	Article 77

Takeaways

For this edition of DG, the doctor will leave the readers with two takeaways. One – there are specific training requirements associated Article 77 to ensure personnel have specialty training (e.g., veterinary training, as appropriate). Two – please ensure the training program is well documented, including records and a well-written procedure. Do not be afraid to hire a professional trainer, if the organization does not have the resource available in-house.

Until the next edition of DG, when the doctor provides guidance on: MO 169 – Chapter 4 “Manufacturing Control and Quality Control in Manufacturing Sites of Biological-origin Medical Device, etc. Manufacturers, etc.” (Article 78 “Control of Documents and Records” and Article 79 “Exceptions to Retention of Records”), sayonara from Dr. D and best wishes for continued professional success.

Note: there is just two more articles remaining for MO 169. If you have a topic you would like to see Dr. D cover, please let me know.

References: 

1. Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation.  Washington, D.C.: U. S. Government Printing Office.
2. EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
3. Final rule – cGMP requirements for combination products. (2013, January). FDA website. Retrieved January 25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products
4. Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 11, 2013, from http://www.linguanaut.com/english_japanese.htm
5. Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf
6. Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf.