Not all Suppliers Need Audits
Why audit suppliers? We explain why some audits are necessary while most are not.
Why audit suppliers? We explain why some audits are necessary while most are not.
Tag Archives: Devine Guidance
CAPA is not Rocket Science
Injecting the CAPA programs with steroids isn’t the answer. It’s best to keep it simple.
Injecting the CAPA programs with steroids isn’t the answer. It’s best to keep it simple.
You Got a Warning Letter, Now What?
Warning letters are life-changing events for device manufacturers; however, it is a recoverable event and can make an organization stronger.
Warning letters are life-changing events for device manufacturers; however, it is a recoverable event and can make an organization stronger.
So You Received a 483 from FDA, Deal with it!
It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.
It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.
MHLW MO 169 – Chapter 5 – Mutatis Mutandis
The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention.
MHLW MO 169 – Chapter 4 – Documents & Records
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.
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.
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.
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.
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.
