Ohayou Gozaimasu. An appropriate Japanese phrase for this final guidance on Ministerial Ordinance 169 is one of Dr. D’s favorites “Hara-Kiri” or the ceremonial disembowelment of the Chief Impalable Officer (CIO) that has failed to maintain compliance with all of the 80 Articles associated with MO 169. For those readers that have been patient and made it through this very long and protracted series on the Japanese Quality System Regulation, I applaud your tenacity and diligence. Reading quality and regulatory stuff is usually quite boring so I hope you have enjoyed Dr. D’s irreverent approach to dissecting the regulatory requirements associated with MO 169. If the readers can walk away from the doctor’s weekly tirades with a fundamental understanding that regulatory and quality compliance is premised on common sense, I repeat “common sense” then your organizations have been blessed with gifted professionals. For readers that remain unclear about the ramifications associated with failing to comply with Japanese regulations, Dr. D has a sword for you to fall on “Hara-Kiri.” In the warped mind of the doctor, this series of Devine Guidance for MO 169 was just “ephemeral” (look-it-up). That being said, I hope you enjoy the last article in the DG series for Complying with MO 169. The movie will be out in the spring and appropriately titled, “Don’t Fall on the Sword.”
Chapter 5 – Manufacturing Control and Quality Control in Manufacturing Sites of In-Vitro Diagnostic Reagent Manufacturers, etc.
(Provisions to be Applied Mutatis Mutandis)
Article 80 For the manufacturing control and quality control in the manufacturing site of the in-vitro diagnostic reagents manufacturer, etc., the provisions of Chapter 2 and Chapter 3 (excluding Items (1) and (2) of Paragraph 4 of Article 8, Items (1) and (2) of Paragraph 3 of Article 9, Paragraph 2 of Article 24, Article 42, Article 44, Article 46, Article 49, Article 59, Items (1) and (2) of Paragraph 1 of Article 72 and Items (1) and (2) of Paragraph 2 of article 72) shall be applied mutatis mutandis. In this case, “other than both the specially designated medical devices specified in Paragraph 1 of Article 77-5 of Law and the medical devices designated by Minister of Health, Labor and Welfare as those of which design and development (hereinafter referred to as “design and development”)” in Paragraph 1 of Article 4 shall read “designated by Minister of Health, Labor and Welfare as those of which design and development,” “defines the complete manufacturing process concerned with the products of the manufacturing site and, if applicable, the installation specified in Paragraph 1 of Article 42 and the servicing specified in Paragraph 1 of Article 43” in Paragraph 3 of Article 6 shall read “defines the complete manufacturing process concerned with the products of the manufacturing site,” “for the following period (5 years for the QMS documents concerned with the training)” in Paragraph 4 of Article 8 shall read “for 5 years (1 year plus the shelf life, for the products concerned with the in-vitro diagnostic reagents of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 5 years, except those concerned with the training),” “for the following period (5 years for the records concerned with the training)” in Paragraph 3 of Article 9 shall read “for 5 years (1 year plus the shelf life, for the products concerned with the in-vitro diagnostic reagents of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 5 years, except those concerned with the training),” “responsible engineering manager specified in Paragraph 5 of Article 17 of Law” in Article 16 shall read “drug manufacturing manager specified in Paragraph 3 of Article 17 of Law,” “responsible engineering manager” in same Article shall read “manufacturing manager,” “Paragraph 2” in Paragraph 6 of Article 62 shall read “Paragraph 1,” “responsible engineering manager” in Article 65 shall read “manufacturing manager,” “responsible engineering manager” in Article 67 shall read “manufacturing manager,” “responsible engineering manager” in Article 68 shall read “manufacturing manager,” “responsible engineering manager” in Article 70 shall read “manufacturing manager,” “responsible engineering manager” in Article 71 shall read “manufacturing manager,” “for the following period (5 years for the documents concerned with the training)” in Paragraph 1 of Article 72 shall read “for 5 years (1 year plus the shelf life, for the products concerned with the in-vitro diagnostic reagents of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 5 years, except those concerned with the training,)” “for the following period (5 years for the records concerned with the training)” in Paragraph 2 of Article 72 shall read “for 5 years (1 year plus the shelf life, for the products concerned with the in-vitro diagnostic reagents of which shelf life shall be displayed and of which shelf life plus 1 year exceeds 5 years, except those concerned with the training).”
What device manufacturers need to know
As stated earlier in this series (many, many, moons ago), according to Merriam-Webster, “mutatis mutandis” has two definitions:
- With the necessary changes having been made; and
- With the respective differences having been considered.
That being said, Article 80 is all about how MO 169 applies to In-Vitro Diagnostic Devices (IVDD). When you take the time to dissect Article 80, it is essentially tailoring the appropriate Articles of MO 169 and applying them to IVDDs. Actually, Dr. D loves the concept of having MO 169 actually delineating requirements for multiple classes of devices versus the FDA having several CGMPs or the European model with multiple Device Directives (three). The doctor recommends focusing on the change in record-retention requirements associated with Article 80. The rest of the material is essentially a cut-and-paste exercise.
What device manufacturers need to do
Not wanting to state the obvious but obliged to do so, make sure you actually read Article 80 and go back and visit each of the Articles as they are tailored to apply to IVDDs. Make sure your engineering manager and manufacturing manager (if your organization has these roles) understand the significance of these changes. Although a relatively minor text change, the manufacturing manager will need to be trained in “Hara-Kiri” and given a sword of their very own to hang on the office wall. In fact, the Chief Impalable Officer (CIO) should perform the training. Article 80 applies to a plethora of previously discussed Articles, so Dr. D is not going to list them in a Sample Matrix.
Takeaways
For this final DG on MO 169, the doctor will leave the readers with just one takeaway. The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention. For everything else, read the Articles and understand how the changes applicable to IVDDs impact each of the applicable Articles referenced. One final note; do not forget to train your manufacturing manager in the proper way to fall onto a sword. The CIO will make an excellent trainer for this exercise.
Until the next edition of DG, when the doctor will surprise the readers with a bunch of random quality and regulatory stuff, sayonara from Dr. D and best wishes for continued professional success.
References:
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012).
- 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
- Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 11, 2013, from http://www.linguanaut.com/english_japanese.htm
- 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
- 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.
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