Internet: https://www.gmp-compliance.org/files/guidemgr/GDP Question and Answers.pdf Origin/Publisher:Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË – Tel. +32 22991111 Office: DM24 02/28 – Tel. direct […]
What is 4M Change? What is 4M? 4M refers to a method of thinking about things in terms of four elements:
Why is washing and drying necessary before sterilization? Civilization has evolved, and technological innovation is remarkable, from steam locomotives to
QCD in Purchasing Management Purchasing management is important in the design and manufacturing process of medical devices.In MDSAP, process The
Design changes are not corrective actions. Correction and corrective action are different. In the course of implementing CAPA (corrective and
All computer systems need CSV implementation The author is often consulted by clients who want to implement CSV because they
What is a Technical Report? In international standards such as ISO and IEC, only “What” can be described. The reason
About Blind Compliance In my consultations with pharmaceutical and medical device companies, I often find that Japanese companies blindly follow
What is a file? The term file often appears in medical device regulations.For example, the Design History File (DHF: Design
