Developing Combined Control Systems IPEC’s first attempt at pulling together the various guidelines into an integrated structure was the development of the Excipient Qualification guideline Provided overall guidance on how to use a number of the related IPEC guidelines to build a credible excipient qualification program from both the makers and the users perspective.

What is TEC and how to combine TEC Elements As IPEC moves into our third decade we now want to take this concept even further and work towards the development of a system of Total Excipient Control TEC

What is TEC and how to combine TEC Elements TEC will utilize all of the existing IPEC guidelines, programs and proposals to build an overall control system TEC covers the controls needed from the time an excipient manufacturer thinks of marketing a chemical as an excipient to the pharmaceutical industry to the time the patient takes the drug product containing the excipient.

What is TEC and how to combine TEC Elements This Total Excipient Control system involves three main areas of control: Excipient Design Controls would include how design criteria are set to meet the requirements for the intended use taking Quality by Design into account. Excipient Safety involves the information which has been developed to support the safe use of the excipient in the intended application at the levels of use expected to be experienced by the patient. Excipient Manufacturing Process Control and Distribution is the area of control traditionally covered by GMPs, Auditing, QC testing, Information Sharing and Supply Chain Security.

TEC Elements Excipient Design (Specs, Stability, Validation, etc.) Excipient Safety (Toxicology, Precedence of Use) Excipient Mfg. Process Control and Distribution (GMP, QA, Supply Chain) TEC

What is TEC and how to combine TEC Elements We will determine where there may be gaps in our current toolkit and develop appropriate guidance or programs to establish Total Excipient Control. What Gaps in Excipient Control Exist? IPEC’s challenge for the future!!!

IPEC Training Webinars Certificates of Analysis – Overview of IPEC's revised guideline based upon changing regulatory requirements. Presenter: John Giannone, Business Manager, Cognis Corporation Significant Change - How to understand and evaluate changes involving the manufacture of pharmaceutical excipients and when reporting is needed. Presenter: David R. Schoneker, Director Global Regulatory Affairs, Colorcon, Past Chairman, IPEC-Americas 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 7

IPEC Training Webinars 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 Co. 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. Quality Agreements - Defining Quality Agreements, General Provisions, and Key Quality Elements Presenter: Alexa Smith, Regulatory Services Manager, Colorcon 8

IPEC Training Webinars Good Manufacturing Practices (GMP) Global Regulations - How they are applied to excipients and GMP for excipients. Understand and Review various global guidelines, IPEC GMP, ICHQ7, WHO GMPs & GDPs ANSI and EXCiPACT highlights. Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials Excipient Auditing - How IPEC Guidance Documents and the Excipient Information Package (EIP) Relate to the Supplier Audit Process Presenter: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials 3rd Party GMP Certification Preparation and maintenance - IPEA, EXCiPACT review Presenters: Dale Carter, Global Quality Director, Silica, JM Huber, Engineered Materials; and Dr. Irwin B. Silverstein. Vice President and Chief Operating Officer, IPEA, and President IBS Consulting in Quality LLC 9

10 IPEA – Third Party Audits Audits of excipient manufacturers and distributors globally against IPEC guidelines –Audit reports available for purchase on audit report warehouse website with approval of the excipient company IPEA audits minimize auditing costs for makers and users – supplements a user’s own audit program For more info:

11 IPEC Offers Excipient Stakeholders a Regional Voice with Global Influence The IPEC Federation, established in 2010 and based in Belgium, is made of regional IPEC organizations –IPEC Americas North, South and Middle Americas –IPEC Europe Europe, North Africa, Middle East –IPEC Japan –IPEC China IPEC guidelines pursue harmonization across IPEC Federation organizations

Globalization: Impact on Excipients Global companies need global excipients –A rarity, due to differing regulations, legislation, guidance IPEC Provides Solutions –Engagement of regulators and governments –Bringing together global industry Excipient makers, users, distributors –Development of white papers and guidances

IPEC-Americas Value Proposition Past Chair Janeen Skutnik-Wilkenson

 IPEC guidance sets the path for development of global science-based approach to excipient GMP, compendial monograph and related matters  Obtain global perspective from makers, distributors and other users  Helps to build inter-company relationships and collaboration among companies on specific topics.  A great way to get consensus on how to solve issues that affect our companies. Value Statements

Encourages participation at different levels, providing my input and experience to build new guidance, documents or tools in benefit of the excipient industry. Provides good tools (such as the Regulatory Reference Page) and industry documents (i.e GMP guidance) that can be used on the job By participating in Sub-Committees, chairing Committees, or just attending the various committees, members get a first hand look at upcoming issues and can be proactive in informing my company of upcoming changes and impact to our business. Benefits to the Individual

Participate in the development of guides for topics that affect the quality of the excipients Companies can communicate the need for a new guidance. IPEC guides and documents are used by companies as a global standard, and companies can encourage suppliers to use the IPEC Guides even if they are not IPEC Members –This helps us not having to customize our responses and actions. I.e. EIP, audit guides, excipient GMP guidelines, distributor GMP. Allow companies to know the trends/issues in the industry from suppliers and drug manufacturers and be able to be part of the solution. Benefits to the Company

We use IPEA webinars and classes to educate internally our own staff in QA, Regulatory, and Technical Services. IPEC gives companies a voice to bring up issues with government agencies. Provides an opportunity to strategically discuss with other companies how the industry as a whole can help to educate, advise and recommend changes to new or upcoming regulations that would affect excipients. IPEC has many resources all over the world and has connections with people in government which are important when companies have issues that need to be addressed quickly. By being a member of IPEC, companies do not have to be singled out if we were to approach government ourselves. We have the anonymity of being part of IPEC when dealing with sensitive issues or trying to amend regulations in our favor. Allow us to know more about worldwide regulations concerning excipients. Benefits to the Company

 As a participant of different committees, it allows members to know more in detail what IPEC is working on and communicate to my company more timely.  Members can bring ideas and the ones from the company to the different committees and initiatives that companies work on.  IPEC participation provides a development opportunity ◦ Regulatory Careers ◦ Leadership ◦ Quality  Attending IPEC meetings is also a great networking opportunity and a chance to interact with guest speakers (FDA, USP, etc) Why Participate

19 Learn More About How to Get Involved with IPEC at IPEC’s contributions –12 industry standard setting Guidance documents –The association has taken leadership positions on impactful topics such as USP’s Chapter on Residual Solvents and FDA’s Guidance on Melamine –Annual regulatory and educational conferences Member company benefits –Influence industry standards –Participate in new developments while they are emerging –Network and collaborate with excipient related companies, academics, and regulators

The House that IPEC Built!! Patient Safety