26/27 January 2021
The actual Japanese requirements on Computerised systems in the area of GMP and GQP (Good Quality Practice) are laid down in the "Guideline on Management of Computerised Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-Drugs".
An unofficial tentative legislation into English is available since 2011. It lists in a fairly detailed way the requirements on the development and operation of Computerised systems. The Japanese Guideline, too, is guided by the classical life-cycle model - development, validation, operation and retirement.
According to the GAMP, software is divided into four categories, requiring graduated measures. Some examples are listed and also examples for systems which are out of the scope of these rules. Altogether, requirements concerning the following points are formulated on 25 pages - and much more in detail than e.g. in EU GMP Guideline Annex 11:
1. General Principles
2. Scope of Application
3. Documentation on Development, Validation, and operations management of computerised systems
4. Development Operations
5. Validation Activities
6. Activities on Operations Management
7. Internal Audit
8. Retirement of Computer Systems
9. Document and Record Management
This Guideline is generally interesting, not only for companies supplying the Japanese market.
Please also see the "Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs" as well as the Japanese Pharmaceuticals and Medical Devices Agency (Pmda) website for further information..
Dr. Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)