Excipient Certification - IPEC Europe

Excipient Certification
EGA
Brussels, 15th July 2009
Dr Iain Moore
Chair Excipient Certification Project Committee IPEC
Europe
EGA 15 July 2009

Why Certification?
• The safety of drug products is dependant on the
safety of all the ingredients that are used to make
them, including excipients
• The excipient supplier has a duty to contribute to
this safety profile
– in manufacture (GMP)
– And in distribution (GDP)
• One key risk mitigation measure is the Qualification
of Excipient suppliers by Users
• Pressure to do more and the current removal of the
Certain Excipients Directive pushes the
responsibility back on the QP, and at what cost?
• 1000s of excipients and 1000s of applications =
1000s and 1000s of more audits
EGA 15 July 2009

Why Certification?
• But what if those excipients with a low risk could
be qualified by another method?
• What if there was a an Internationally and
regulatory acceptable Excipient certification
system?
• Recent signals from the EU and FDA have
confirmed the acceptability of 3 rd party audits
– But indicted that auditor competency is a
critical factor
EGA 15 July 2009

Do we need another Excipient
Certification Scheme?
• Several Schemes increasingly available
– Pharmaceutical Quality Group PS 9100
– EFfCI (for Cosmetic Ingredients)
– IPEA
– USP Verification
– Rx-360?
• Has there been widespread uptake? If not – we need to
understand why
– Is it because Users are uncertain of the value of these certificates
to the regulatory authorities?
– $$$?
EGA 15 July 2009

Excipients GMP GDP Certification
Project
• EFCG and IPEC Europe signed a MOU in May 2008 to generate
a global excipient certification scheme
• The Certification project scope is huge and so requires other
partners to contribute their collective experience and expertise
• These now include
– EFCG – European Fine Chemicals Group
– IPEC Europe
– IPEC-Americas
– PQG - Pharmaceutical Quality Group
– FECC – European Association of Chemical Distributors
EGA 15 July 2009

Excipient Certification
Project Principles
Evolve existing best practices from all known
sectors
• Base on the IPEC-PQG GMP Guide 2006
• Base on IPEC GDP Guide 2006 & SQAS
Distributor ESAD Scheme
• Align to ISO 9001
– Many excipient suppliers are already ISO
certified or familiar with this quality
management system standard
International in scope
Excipients are a worldwide commodity
EGA 15 July 2009

Excipient Certification
Project Principles
Be valuable and acceptable to Suppliers, Users and regulators
Include as many Excipients as possible
• Classify excipients
• Set the standards in relation to the risk posed
• Set standards that are achievable ($)
• Set standards that are auditable ($)
Address the definition of and policing of auditor competency
Be accessible to existing 3 rd party audit organisations
Consult with all Stakeholders throughout the project
EGA 15 July 2009

Excipient Certification
and Supply Chain Security
1. Certification
Development
1. Classification
Classification
GDP
2. GMP
3. GDP
4. Auditor
Competency
GMP
Auditor
Competency
Scheme
5. Certification
Scheme
Rules
EGA 15 July 2009

Excipient Classification
• Why classify Excipients?
– They have many diverse uses, functions,
manufacturing processes and origins
– A one size fits all definition of GMP is not going
to be enough
• 2 critical risk factors were identified and verified
as the most relevant in Classifying excipients
1. The route of Administration of the drug product
(Dose)
2. The functionality imparted by the excipient to the
drug product (Function)
• Excipient classification to be part of contract
review / quality agreement between supplier and
user
Classification
EGA 15 July 2009

Excipient GMP
• Full ISO 9001 annex now fully drafted and
being reviewed in project
• Enhanced GMP for Function and Dose being
developed
• NSF Standard task force being developed for
conversion to US national standard
GMP
EGA 15 July 2009

Excipient GDP
• As for GMP a GDP Annex to ISO 9001 is
being developed
• Organisations will be able to attain GMP
certification alone or in combination with
GMP
GDP
• The GDP Task force will also build on the
European SQAS ESAD II assessment
scheme Section F&G (www.sqas.org)
EGA 15 July 2009

Auditor Competency
Auditor Competency requirements
• Will cover GMP and GDP aspects for auditor
competency
• Need to access as many auditors as possible
• Training materials will be made available for
auditors
• European regulators invited and agreed to
review outputs of this taskforce
Auditor
Competency
EGA 15 July 2009

Certification Scheme
• A “fifth component will be to develop and define
the certification scheme rules
• A new task force will be assembled to deliver
this shortly
• Will use existing schemes as the basis for
development
– PS 9100 has defined auditor competency (PQG
602)
– EFfCI GMP Certification Scheme
– SQAS ESAD II Scheme
• For the NSF standard the certification scheme
will be the same as any other NSF standard
Scheme
Rules
EGA 15 July 2009

Excipient GMP & GDP
Certification Scheme
AUDIT
Certification Plans
• Supplier or User
commissions 3 rd
Party
• Who is accredited
by national
competent authority
• Supplier passes
evidence of GMP
and GDP to User
• User passes details
to regulators at
inspection or in
dossiers
• Virtuous circle
CERTIFICATE OF
GMP COMPLIANCE
USERS
EGA 15 July 2009
SUPPLIERS &
MANUFACTURERS
CERTIFICATION
ASSURED EXCIPIENT USE
REGULATORS
3rd PARTY
ACCREDITATION

Excipient GMP & GDP
Certification Scheme
Virtuous Circle
• Could there be
some kind of
regulatory
relief to
users?
• Dare I dream
of less user
audits?
EGA 15 July 2009

Excipients GMP GDP Certification
Project
• Project has been running actively for 7 months
• The team members include Excipient Suppliers, Distributors
and Users with all sectors making major contributions
• A key component of the project has been to build in
stakeholder consultations
– In Europe in May with representatives of Innovative Pharma,
Generic Pharma and European and National authorities
– In the US a meeting is planned with the FDA this month
EGA 15 July 2009

Excipient GMP GDP
Certification
None of this is realisable without the
commitment and contribution of all the
volunteers to the various working parties
and the Steering Committee
I thank them for all their efforts
Thank you for your attention
EGA 15 July 2009