Regulation authorities (Germany):
Bundesministerium für Gesundheit und Soziale Sicherung
Bundesinstitut für Arzneimittel und Medizinprodukte
Veröffentlichungen des Robert Koch-Institutes
Aseptic Filling:
PHARMACEUTICAL INSPECTION CONVENTION
http://www.fda.gov/cder/guidance/5882fnl.htm#top
Process Analytical Technology:
FDA: PAT guidance
CDER: PAT initiative
ASTM: Committee E55 on Pharmaceutical Application of Process Analytical Technology
IFPAC: PAT
AAPS: Focus group PAT
ISPE: Discussion forum PAT
CPAC: PAT summer institute 2005
FDA: Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach, Final Report 2004
