EU GMP guideline
The EU GMP guideline summarizes all regulations and operating instructions that have ever been specified for pharmaceutical companies in the Federal Republic of Germany. This guideline and all it annexes…
EU GMP Guideline Annex 11
Annex 11 of EU GMP guideline. It describes requirements for all kinds of computerized systems used as part of GMP-regulated activities.A computer-based system is a combination of software and hardware…
EU GMP Guidelines Chapter 4
The chapter 4 relates to the documentation. A good documentation is an essential part of the quality management. Moreover, it constitutes a key function for the production in compliance with…
EU GMP Guidelines Chapter 7
Chapter 7 “Outsourced Activities” of the EU GMP Guidelines deals with the responsibilities of the contractor and contracting entity in the case of outsourced activities. Basically, the chapter states that…