Date post: | 04-Jan-2016 |
Category: |
Documents |
Upload: | jack-newton |
View: | 220 times |
Download: | 2 times |
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?