There are some unique record-retention requirements associated with Ministerial Ordinance 169: So employ a little bit of common sense and script just one well-written SOP for all of your organization’s needs.
MHLW MO 169 – Chapter 4 – Training
There are specific training requirements associated Article 77 to ensure personnel have specialty training; ensure that this training is well documented, including records and a well-written procedure.
MHLW MO 169 – Chapter 4 – Testing
If you are manufacturing a biological-origin component, make sure the test procedures employed are documented (in writing) and test methods validated. If you are purchasing the component of biological origin, it is imperative the suppliers comply with Article 76.
MHLW MO 169 – Chapter 4 – Process Control
Please ensure that the cleanroom/controlled environment has been properly validated and that adequate ongoing monitoring of the operating environment be sustained.
MHLW MO 169 – Chapter 4 – Manufacturing Control & Quality Control
Similar to other devices being shipped into Japan, the Japanese equivalent of a technical file is required for devices containing a derivative of biological origin.
MHLW MO 169 – Chapter 4 – Infrastructure
The Japanese regulatory authorities take seriously the need to adequately identify and control medical devices that contain a biological-origin component, requiring establishment and validation of a cleanroom/controlled environment for manufacturing activities.
MHLW MO 169 – Chapter 3 – Control of Documents & Records
If documents and records do not exist, are illegible, or lack accuracy and detail, then all bets are off when dealing with the regulatory gods in Japan.
MHLW MO 169 – Chapter 3 – Training
Training is one of the areas that result in many non-conformances being issued during quality system audits.
MHLW MO 169 – Chapter 3 – Internal Audit
The performance of internal audits is one of the viable tools that should reside in any respectable organization’s quality management system tool chest.
MHLW MO 169 – Chapter 3 – Corrective Actions
Corrective action should never be considered a bad thing; in fact, a fully functional approach to CAPA can result in a viable tool for driving organizational change.
