IPEC Federation

Dr Patricia RafidisonIPEC Federation

Dow Corning Corporation

ExcipientFest Asia November 28th 2012 - Beijing

The journey update

IPEC* Federation mission

Promoting the quality, safety and functionality of pharmaceutical and

related healthcare products worldwide

*IPEC: International Pharmaceutical Excipient Council

The journey update

Recognises that the drug market is global, including excipient sourcing

Monitors regulatory developments from multiple perspectives and geographies

Represents an industry speaking as ‘one voice’ for common global issues

Builds on IPEC « unique » set up: users, producers and distributors of excipients sharing the same « quality and safety » vision to benefit patients

IPEC Federation

The journey update

IPEC Federation Founding Board

IPEC Federation creation – Cannes 2010 - France

The journey update

• Concept was born in 2009– Evolved from TriPEC

• Meetings with Pharmacopoeial Discussion Group• IPEC foundation: IPEC Americas, IPEC Europe, JPEC

• The need – Formalize interactions between PECs– Provide a mechanism for developing consensus-

based positions across geographies– Set priorities for issues that interest/affect

members globally

IPEC Federation: What is it?

The journey update

Federation statutes◦ ‘Not for Profit’ association based in Belgium (ASBL)

Membership:◦ Full members: IPEC Americas, IPEC Europe, IPEC Japan and IPEC China◦ Associate partners (Argentina, Brazil)

Operations◦ One « assemblée générale » per year ◦ Governance principles detailed in the IPEC Federation Policy Manual

IPEC interactions◦ Each PEC is independent and responsible to monitor and comment on

regulations within its geography◦ Input from other PECs may be provided either individually, or via the

Federation

IPEC Federation setup

The journey update

IPEC Federation – Expansion

Efforts are currently underway to form IPEC India as an Associate member of the Federation

Formal association registration is in process and is expected completed in December 2012

The journey update

IPEC Federation - Partnerships

The IPEC Federation has formed formal partnerships with other trade associations in Brazil and Argentina

These partners are translating IPEC Guidelines into their local languages

The IPEC Federation works with each organization to hold periodic excipient conferences in its country

The journey update

IPEC – Brazil PartnershipSindusfarma Agreement -May 28, 2009

The journey update

IPEC- Argentina PartnershipSafybi Agreement – August 12, 2010

The journey update

Managing global regulatory expectation◦ Identify emerging regulations impacting excipients◦ Establish position papers on any relevant advocacy activity

Harmonisation of standards◦ Work with PDG to continue the harmonisation process of

pharmacopoeial monographs◦ Develop harmonised voluntary industry guidance for global use

Promoting supply chain security

◦ Excipient risk management◦ Third party certification

IPEC Federation key objectives

The journey update

IPEC Federation Priorities February 2012

Urgency

Imp

act

on

Mem

ber

s

QbD/PAT / FRC

Managing Global Reg

Expectations

Paediatrics

GTIsDS

Recomb. Excip

HarmonisationPZ

Safety

Resid. Solv

Supply Chain

(incl. Counterfeiting)

Risk Mgmt / contingency

DC

Innovation / New

Excipients

3rd PartyCertification

DC

New Analytical

Techniques

Allergens

Nanotech

Excip. CompCo-

processed

Atypical Actives

JSW

VisibleParticules

DS

E DMFDL

Elemental impurities

JSW

The journey update

Harmonisation of excipients monograph globally Excipients certification program Risk management /assessment of excipients ICH Q3D Elemental analysis Excipient Master files Apply appropriate GMPs to atypical actives

IPEC FEDERATION 2012 Priorities

IPEC and stakeholders

Harmonisation of excipient monographs

Drivers

Lack of consistency for the same excipient in monographs

Tests to be repeated or different in most regions

Increased costs for non-value added activities

Impact on registration submissions

Pharmacopoeia : establish PDG (Pharmacopoeial Discussion Group)

IPEC Federation: Voice of the excipient industry users, prodcuers and distruibutors providing expertise and data collection

Participate in the design of the future for harmonisation

The journey update

Harmonisation of excipients

Further the work of excipient harmonisation◦ Continued partnership with PDG (Pharmacopoeial

Discussion group)* via a Biannual meeting with the IPEC Federation

Contribute to the future vision of pharmacopoeia, ◦ Considering new pathways forward to speed up process◦ Prospective harmonization of new excipient

monographs

* PDG is made of EP (European Pharmacopoeia), JP (Japanese Pharmacopoeia), USP (United States pharmacopoeia)

Excipients certification programme

Drivers

Risks in the pharmaceutical supply chain are not just API related, excipients may be impacted

Regulators expect “Market Authorization Holders” to secure their supply chain

The appropriate way to achieve this is by means of periodical, physical audits

The economical burden associated to these requirements are impacting both manufacturers and users

Excipact TM developed by industry consortium (IPEC Europe, IPEC Americas, EFCG,FECC, PQG)

Third party auditing scheme developed using GMP and GDP auditable standards

Excipact Standards are now published; ANSI standard are currently developed, and are aligned

Share audits programme provided by IPEA, accredited by ANSI

Both programmes use IPEC-PQG GMP or/and IPEC-PQG GDP guidelines

Third party certification bodies have signed up for EXCIPACT TM

IPEC and stakeholders

The journey update

A voluntary self regulated initiative of the global pharmaceutical excipient manufacturing, distributing and processing industry supported by excipient users

EXCiPACTTM ensures contemporary GMP and GDP requirements are applied to pharmaceutical excipients through a recognized auditing and certification process thereby increasing safety and reliability as well as transparency, of the pharmaceutical supply chain

· EXCiPACTTM is accepted by all major stakeholders including relevant authorities globally

· As an independent organization EXCiPACTTM will be able to objectively set GMP and GDP standards today and in the future

· EXCiPACTTM certification provides a cost-efficient method of ensuring GMP and GDP are applied throughout the pharmaceutical supply chain by reducing the audit burden

More on EXCiPACTTM scheme

The journey update

More on EXCiPACTTM scheme

Process Flow

1. Supplier selects approved 3rd party audit company

2. EXCiPACTTM issues registration no to 3rd party audit company

3. Audit will be performed and certificate issued

4. Supplier pays audit fee (including certification fee) to 3rd party certification body

5. 3rd party audit company pays certification fee to EXCiPACTTM and informs about audit result

6. Supplier provides audit results to excipient user and upon request audit documentation

7. Excipient user can verify the audit with EXCiPACTTM

8. EXCiPACTTM reserves rights to attend audit or to analyse audit report in order to warrant standards

18

EXCiPACTTM 3rd Party Audit Organisation

Excipient user

ExcipientSupplier

Excipient user1

2

34

56

6

7

8

Excipient Risk Assessment

Drivers

Regulators require a risk based approach when implementing regulations

Increased enforcement of regulation impacting excipients, and expectation to comply with GMP and/or GDP using risk assessment

Risk management tools exist ( ICH Q 9), the specificity of excipients is not addressed

Excipient Risk Analysis and Evaluation to be developed by IPEC◦ Considerations for and

perspective of the Excipient Maker

◦ Considerations for and perspective of Excipient User

Excipient Risk management guideline currently being developed

IPEC and stakeholders

Elemental impurities – ICH Q3D

Drivers

Elemental impurities is addressed in USP Chapters and is close to implementation (2013) and will impact excipients

ICH Q3D working group on elemental impurities has recently been set up to address this subject

Suppliers of excipients are looking to assess their products so that they are using the appropriate test methods and detection limits, which will be necessary once the limits are established

IPEC Federation observer at ICH Q3D (2010)

Input from most impacted suppliers gathered via workshop in 2012

Coalition from industry provides feedback to stakeholders with data and request to allow reasonable timeline for compliance

IPEC and stakeholders

Excipient master files

Drivers

Excipient-sensitive information needs to be protected, whilst facilitating users’ registrations

Systems exist in some geographies (USA, Japan); new systems are being developed (China)

No process in Europe

Share information about developing regulation, and highlight excipients specificity

Advocate the creation of DMF system in most geographies

Share DMF template, and suggest process to manage confidentiality

Reinforce the need for harmonisation and mutual acceptance of excipient global regulatory status

IPEC and stakeholders

Atypical actives

Drivers

Some excipients are used as active ingredients in pharmaceutical applications

Regulations are evolving, and require GMP for API to be applied to these ingredients

Organise conferences and workshop to clarify the status of these ingredients

To prevent a shortage of these ingredients, industry proposes adopting IPEC-PDG GMP guidelines as an appropriate reference

IPEC and stakeholders

The journey update

Enforcement of regulations for excipients becomes a reality◦ In China, new regulations for excipients prepared

by SFDA◦ In the USA, FDA reinforces the need for increased

controls of excipients◦ In Europe, the Falsified Medicines Directive makes

GMP applicable to excipients, using a risk-based approach

◦ Excipients GMP are expected to apply in Brazil

Monitoring emerging regulations

The journey update

IPEC Federation is the unique association that regroups excipient experts from the user, producer and distributor community

IPEC Federation is developing via its members a strong foundation to support industry and authorities to provide safe and quality excipients for the benefit of patients

The world has no boundaries anymore, harmonisation and collaboration between all stakeholders is essential to continue to protect public health

To conclude

Thank you for your attention

Questions?