What Is Annex 1 and Why Is It Important?
Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
What Are the Major Changes?
The last revision to Annex 1 in 2008 contained 123 items. This revision has produced a completely new document, reorganized in alignment with GMP in Europe. With 269 major points, it addresses signiﬁcantly more details.
This e-book from Pharmaceutical Online, focuses on that the varying guidelines that will affect sterile pharmaceutical manufacturing operations.