Launch of IPEC/PQG Excipient GMPs guide Kevin McGlue, Steve Moss. IPEC/PQG Excipient GMPs guide. The organisations Background Key milestones Joint charter (governance and oversight) Development process Major improvements Benefits to Industry and Regulators Implementation Strategy.
IPEC/PQG Excipient GMPs guide
Kevin McGlue, Steve Moss
23rd January 2003
Started March 2003
Q2 2003 to Q1 2004
Q2 to Q3 2004
Q4 2004 to Q3 2005
1. Members comment x2 (some external bodies eg EFPIA via members)
2. External circulation - Key organisations including regulatory authorities, trade organisations and other stakeholders
3. Issued to members for final comment
4. Comprehensive QC checks x2 teams
Thanks to the GMP/Partners groups and the wider membership of each organisation for help and excellent contributions!
1. Broadacceptance (cont’d)
2. Ease of application
2. Ease of application(cont’d)