The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention.
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.
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.
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.
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.
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.
Training is one of the areas that result in many non-conformances being issued during quality system audits.
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.
A corrective action procedure requires a significant amount of intelligent thought to ensure all aspects required of an effective corrective action process are captured. Plan ahead and incorporate the preventive action requirements (Article 64) into the corrective action procedure; thus, creating a CAPA procedure.
Make sure that the procedure scripted by your organization addresses all of the requirements associated with “Improvement” (Article 62). Since most medical device manufacturers get the complaint management piece right, let’s focus on what is often missed.