1. Launch of the PQG Supply Chain Risk Management Guide
RPSGB, London 23rd February 2010
Pharmaceutical Quality Group
April 27, 2019

2. Agenda Time Topic Speaker April 27, 2019
10:00
Welcome by chairman
Ashley McCraight - PQG
10.05
Introduction to PQG Partner’s projects
Steve Moss – PQG
10:15
Introduction to the Guide
Jill Jenkins – PQG
10:45
Regulatory perspective on supply chains
Gerald Heddell – MHRA
11.30
Coffee break
11:45
Risk Management for Medical Devices
James Pink – Pink Associates
12:15
The Guide Toolbox and Examples
Justin Ahern - PQG
12:45
Lunch
14:00
Pharmaceutical industry and ICH Q9
Peter Gough – David Begg Associates
14:30
Challenges facing Excipients supply chain
Ian McKeown – IPEC
15:00
Challenges facing API supply chain
Francois Vandeweyer – APIC
15:30
Rx-360 – what next?
Lorna Third - Rx-360
16:00
Questions and close
General welcome & high level intro
Intoductions
April 27, 2019

3. Launch of the PQG Supply Chain Risk Management Guide
RPSGB, London 23rd February 2010
Pharmaceutical Quality Group
April 27, 2019

4. PQG Partners Team PQG & Partners Team Chartered Quality Institute
Pharmaceutical Quality Group – committee
PQG Partners - steering committee
Norman Randall (Chairman), Ashley McCraight, Steve Moss,
Ian Richardson, Justin Ahern
PQG Partners Team
Steve Moss (Leader), Tony Harper, Jill Jenkins, Linda Nield, Justin Ahern
PQG Partners Project teams
April 27, 2019

5. PQG Partners Team Aims & objectives
The Pharmaceutical Quality Group Partners Team will promote the application of appropriate GMP for suppliers to the pharmaceutical industry through:
developing, publishing and maintaining standards and guidance
collaborating with other organisations with similar aims on projects for standards and guidance
maintaining a process for certification of suppliers against PQG standards
maintaining a process for assessment of training in PQG standards and guidance
certification of auditors used by certification bodies for assessing suppliers against PQG standards
April 27, 2019

6. Partners Team - record
1990 & 1995 Pharmaceutical Supplier Codes of Practice
PS 9000 Pharmaceutical packaging materials
PS 9100 Pharmaceutical excipients
PS 9004 Guidance for implementing PS 9000
1991 – Auditor and Training course standards designed
Contribution
EFfCI GMP Guide for Cosmetic Ingredients
ISO Primary packaging materials
2006 – IPAC-RS Materials for inhalation products
Collaboration
IPEC/PQG Excipients GMP Guide
2008 – IPEC/PQG Excipients GMP Audit guide
2010 – PQG/IPAC-RS PS 9000:2010 Pharmaceutical packaging mats
April 27, 2019

7. Partners Team - record
Packaging materials suppliers certified to PS 9000:
50 UK & NI
19 Overseas (Eire 12; Sweden 3; Malta 1; China 1; Poland 2)
69 Total
Excipients suppliers certified to PS 9100 = 3
Auditors certified to PS scheme = 12
April 27, 2019

8. Current PQG Partners projects
Leader
Risk Management in the Supply Chain
Guidance for pharmaceutical industry and their suppliers
Jill Jenkins
IPEC/PQG Excipients GMP standard
For certification schemes proposed in Europe & USA
Steve Moss
PS 9000:2010
Development of PS 9000 in collaboration with IPAC-RS
David Abraham
Common Questionnaires
Minimise supplier time responding to multiple customer formats
Linda Nield
ISO developments
Extension to secondary packaging & guidance
Tony Harper
April 27, 2019

9. PQG Partners Project Teams
Volunteers for project teams are always welcome
Contact:
April 27, 2019