Standards and Guidelines

Below Standards & Guidelines followed by Akility.

ISPE - GAMP® 5 (Good Automated Manufacturing Practice) guidance:

Eudralex (European Commission) GMP references :

Eudralex (European Commission) GDP references :

Falsified Medicines Directive (FMD)
Directive 2011/62/EU of the European parliament and of the council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products:

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (text with EEA relevance) :

EMA (European Medicine Agency) references :

FDA (US Food & Drug Administration) references :

MHRA (Medicines & Healthcare products Regulatory Agency) references :

Santé Canada - Health Canada references :

PIC/S (Pharmaceutical Inspection Co-operation Scheme) references :

USP (US Pharmacopeia) references :

WHO (World Health Organisation) references :

PDA Journal (Parenteral Drug Association) references :

IVT Network (Institute of Validation Technology) references :

ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé- France) references :

Microsoft GxP references :

COBIT (Control Objectives for Information and Related Technologies) references :