GAMP UK
Thursday 23rd April 2015, Astellas PharmA EMEA,
Chertsey
Location> Astellas Pharma EMEA, Chertsey
• Co-Chairs: Mark Foss, CooperVision and
• Thana Subramanian, Otsuka Europe
• 09:00 Arrival and Refreshments
• 09:30 Chairman’s Welcome
• Mark Foss,
• 09:45 Sponsor’s Welcome
• Andrew Warren, Astellas Pharma EMEA
• 10:00 Case Study: Global Harmonisation of
IT and Validation Processes
• Genni Sanders, Astellas Pharma EMEA
• 10:45 Networking and refreshments /
New members welcome to GAMP
• Roger Buchanan, Eli Lilly & Heather
Watson, GlaxoSmithKline
• 11:15 ISPE Special Interest Group (SIG)
Updates
• Chris Reid, ISPE International Board of
Directors
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12:00 Regulatory Intelligence
John Andrews, Integrity Solutions &
Heather Watson, GlaxoSmithKline
12:30 Lunch
1:30 Round Table Sessions
(1) Agile – Chris Reid, Integrity Solutions &
John Andrews, Integrity Solutions
(2) Cloud – Trevor Simmons, Zigzag
Associates, David Stokes, Percipient
Consulting
(3) TBC
2:30 Networking and refreshments
3:00 Round Table feedback and
discussion
3:30 Introduction to and discussion on:
MHRA Guidance on Data Integrity
Nichola Stevens, Alere & John Andrews,
Integrity Solutions
4:15 Q & A
4:30 Close
GAMP® & GMPs for the
21st
Century
…
How did we get to here?
International Society for Pharmaceutical Engineering
ISPE
Good Automated Manufacturing Practice
GAMP
3
The Beginning
FDA
Blue Book
EU
Orange
Guide
Annex 11
?
Practical guidance needed on how to implement
The Beginning
FDA
Blue Book
EU
Orange
Guide
Annex 11
V-MAN
Do what we can...
Don’t try to do everything at once
A review of
History of Computer System Validation
1979 - FDA 483s are issued for faulty
control of computerized systems
1983 - Guide to Inspection of
Computerized Systems Used in the
Manufacture of Drug Products
(Bluebook) published
1987 - Software Development Activities
Reference Materials and Training Aids
for FDA Investigators
1987 – FDA Compliance Policy Guide on
Source Code
1988 – Japanese MHW issues GLP
Inspection of Computer Systems
1989 – UK DoH publishes The
Application of GLP Principles to
Computer Systems
1990 – The Australian TGA publishes
Code of GMP for Therapeutic Goods,
includes expectations for computer
systems
1990 - Drug industry inquires about "going
paperless“
1991 – EU publishes GCP for Trials on
Medicinal Products, includes expectations
for computer systems
1992 – Japanese MHW issues Computer
Control Guidelines for Drug Manufacturing
1992 – ER/ES Proposed Rule published
1993 – EU publishes GMP for Medicinal
Products, includes computer system
expectations
1995 - GAMP first published
1995 – Annex 11 (Computerized Systems)
added to EU GMP
1995 – FDA publishes Glossary of Computer
Terminology
A review of
History of Computer System Validation
1996 - Software Development Activities
Reference Materials and Training Aids for
Investigators updated
1997 - Draft General Principles of Software
Validation
1997 - Japanese MWH issues expectations
for Retention of Electronic Records
1997 – MCA issues guidance on Electronic
Signatures
1997 - 21 CFR Part 11 becomes effective
1998 - Guide to Inspections of Computerized
Systems in the Food Industry
1998 - GAMP update
1999 - Guidance for Industry "Computerized
Systems used in Clinical Trials“
2000 – ICH publishes GMP for API with section
on Computer Systems
2001>2 - GAMP4 and General Principles of
Software Validation; Final Guidance for
Industry and FDA Staff
2003 - Guidance for Industry Part 11, ER/ESScope and Application
2003 – PIC/S issues Good Practice for
Computerised Systems in Regulated “GxP”
Environments
2008 – GAMP5 A Risk-Based Approach to
Compliant GxP Computer Systems
2011 – EU GMP Annex 11Update
PICSVF [Pharmaceutical Industry Computer Systems Validation Forum]
Rare photo of the original team
Only the Welsh could pronounce their name
1991
1996
Pivotal 1994
Inspections
Draft
1998
1995
Supplier
Guide
(GAMP V1)
Supplier
Guide
(GAMP V2)
9
GAMP
Guide
(GAMP V3)
GAMP
PDA
Liaison
Americas
2000
2004/5
2001
GAMP4
2003
GAMP
Japan
2008
Good
Practice
Guides
10
Risk Based Approach
Still being
refined…
11
Scalability – does one size fit all?
GAMPers investigating
scaleable approaches
12
GAMP as part of ISPE
• Two big steps in 2000 helped GAMP
become truly global


GAMP became part of ISPE
GAMP Americas and GAMP Japan formed
later that year
• Other regional and local GAMPs grew
organically
• GAMP became (and remains) the model for
the COP concept
GAMP — The Document Factory
• GAMP 4 and GAMP 5 are
the two best selling ISPE
documents of all time.

GAMP 3, 4, & 5 have brought
ISPE over $3.3 million in net
income since 1998
• After 4 years on the market, GAMP 5 still has
the highest average monthly sales of any
document
14
GAMP was the First ISPE
Community of Practice?
Governance Model
Aims of GAMP® UK
• To promote:

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
GAMP principles of Risk Based Approach and effort focussed on
patient safety
Sharing of practical experience of regulated companies and
supply companies when implementing GAMP good practice
Understanding of current regulatory and industry developments
• To provide a UK voice at GAMP global forums
• To facilitate engagement of UK members in GAMP
initiatives
• To facilitate the sharing of cross industry good practice
Keep you
up-to-date
Share
practical
experience
Enable you to
influence
GAMP
direction
Who should attend?
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Regulated companies
Product suppliers
Service providers
Consultants
Regulators
•
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Management
Engineers, IT
Business Users
Quality Assurance / Management
Operating Principles
• Share practical experience / case studies /
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•
workshops rather than training
Share experience of regulatory audits
Utilise “FOC” or low cost facilities of kind
volunteers to make attendance more cost
effective
2 meetings/year, one North, one South
Listen to members to identify topics of greatest
interest and need