IPEC Americas General Update
February 24, 2011
Dale Carter
Chair, IPEC Americas
1
New Executive Committee
• Chair Elect David Klug
• VC Administrative Affairs John Giannone
• VC Harmonization & Compendia Monographs Priscilla
Zawislak
• VC Membership Marc Fages
• VC Science & RA David Schoneker
• XC Nigel Langley
• XC Gwyn Murdoch
• VC user Relations < in process >
2
Budget Update
• Ended 2010 - $44K over budget (made up
with reserves
• 2011 – under %50 dues collected but on
target with last year
• Dues increase in place and should help
close the gap in the budget
• Legislative update currently under
funded
3
Early Successes
• Great meeting with FDA with positive
comments on Composition guide and IPEC
GMP/GDP
• Training webinar on Significant Change
big success
• Great project with FDA on spectral
library
4
Future Training
• March 15: Certificates of Analysis -Overview of IPEC's revised
guideline based upon changing regulatory requirements. Presenter:
John Giannone, Business Manager, Cognis Corporation
• April 12: Excipient Pedigree - Why and how an understanding of
the supply chain history of excipients is critical to the safety of
drug products. Presenter: Linda Herzog, Marketing Director, Asahi Kasei
America
• May 17: Stability - Methods and rationale for determining
excipient stability; IPEC's common sense scientific approach to
stability studies for excipients stored and transported via
uncontrolled conditions. Presenter: Philip Merrell, Ph.D., Technical
Marketing Manager, Jost Chemical Company
• June 21: Validation - Learn about IPEC's needed validation
guideline on manufacturing processes, analytic methods and
cleaning. Presenter: Ann Van Meter, Senior Quality Systems Specialist,
DowWolff Cellulosics.
5
20th Anniversary & Excipient Fest
• Please register and bring others from your
company
• Hotel rooms will run out
• Gala Dinner for IPEC Foundation (bring spouse
and friend to diner for $150 each)
• Total Excipient Control to be introduced during
our 20th Anniversary Conference on Monday
• Great meet and great cocktail Sunday night
6
Legislative Initiative
• Initial efforts have focused on food safety legislation, which
contains third-party certification language.
• Food Safety Legislation: In Late November, the Senate
passed S. 510 FDA Food Safety Modernization Act. The bill
passed 73-25. Since the Senate Bill creates fees, violating a
constitutional requirement that tax bills must originate in the
House of Representatives, an abbreviate process starts again in
the House.
• HR 2751 signed into Law January 4, 2011
– Contained language favorable to current 3rd party audit
scheme
7
Excipact – ISO 9001 Excipient GMP Annex
• Now a working sub-committee of IPEC
Federation
• Incubator until Excipact can launch as an
independent group
• IPEC Fed to provide
– $ money
– Staff
– Sign contracts, publish docs, do legal stuff
8
BENEFITS OF
EXCIPACT CERTIFICATION
TO SUPPLIERS, USERS AND PATIENTS
The role in Supplier Qualification
SWIPED From
Iain Moore, Excipact Project Co-ordinator
EMA February 10th 2011
Excipact - Minimise the Risks, Maximise the Benefits
Excipact Certification
Excipact: Good Manufacturing
Practice (GMP)
 Annex to ISO 9001 developed from the
IPEC-PQG GMP Guide 2006
 Builds on the basic Quality
Management System required in ISO
9001 and amplifies the requirements to
include the GMP principles in the IPECPQG GMP Guide
 Assessment of ISO 9001 and Excipact
GMP can be simultaneous
10th Feb 2011 London
Excipact - Minimise the Risks, Maximise the Benefits
10
Excipact Certification
Excipact: Good Distribution Practice
(GDP)
 Annex to ISO 9001 developed from the
IPEC GDP Guide 2006
 Annex contains specific requirements for
Good Distribution Practices
 Allowance for different distributor/trader
operations
 In-line with SQAS ESAD Section F&G
(www.sqas.org)
 Where there is overlap, GMP- and GDP Annexes contain same requirements
10th Feb 2011 London
Excipact - Minimise the Risks, Maximise the Benefits
11
Excipact Certification
Quality of auditors is critical
 Excipact includes a section devoted to auditor
competency using ISO 19011 framework with additional
requirements for GMP and GDP
 Alternative starting routes to qualification possible i.e.
experienced in ISO 9001, GMP or GDP
 Considered best practices e.g. SQA and Qualified Person
assessment processes
 Training Guide included with specific requirements for
Excipients
10th Feb 2011 London
Excipact - Minimise the Risks, Maximise the Benefits
12
Excipact Certification
Excipact - how will it work?
 Excipact invites bids from 3rd Party Assessment
organisations
 Legal agreement signed for them to adopt the
requirements, including Auditor competency
 Excipact to train the trainers – who will train the auditors
Excipact Website
 List of Third Party Certification Providers
 Directory of certified excipients suppliers
 List of certifications suspended and withdrawn
10th Feb 2011 London
Excipact - Minimise the Risks, Maximise the Benefits
13
Excipact Certification
Excipact - how will it work?
 Supplier selects 3rd Party Assessment organisation
(ideally the one that already provides ISO 9001
certification)
 Supplier identifies if GMP and or GDP parts are needed
 Standard ISO certification audit process – pre audit, full
audit, CAPA, Certification
 At least Annual surveillance audits and triennial recertification - a frequency likely to be higher than any
MAH could manage, even for high risk excipients
 Costs (financially and time) are comparable to ISO 9001
certification
10th Feb 2011 London
Excipact - Minimise the Risks, Maximise the Benefits
14
Excipact Certification
Excipact - how will it work?
 Audit Report lists observations and rates findings as
critical, major or minor
 3rd Party Technical Experts review audit report and
findings, recommend certification if
No critical, no major without CAPA, no minors that indicate
failure of quality system element
 Audit Report available to pharmaceutical customer from
excipient supplier – may be redacted to show that
confidential information has been hidden – but
substance of report will not be altered
10th Feb 2011 London
Excipact - Minimise the Risks, Maximise the Benefits
15
IPEA Update
• Conducted five separate training workshops for pharmaceutical
industry product quality personnel.
– Excipient GMP auditing (2),
– Excipient validation;
– Changes in excipient manufacturing, their possible effects in finished
products and when they need to be reported to customers.
– Excipients in General
• Reviewed the necessary and essential elements of manufacturing practice
when an excipient material is intended for use in a finished drug
formulation and data needed to establish the safety and functionality of a
drug component.
• Successfully obtained accreditation by ANSI of IPEA's Excipient GMP
Conformance Certification Program
– Signifies conformance to ISO/IEC Guide 65.
– Following this 4 separate certification audits have been conducted and
others are pending
16
Dancing Guitar Dave
-PDA – Atypical Actives
-TEC for 20th Anniversary
17