Update Topics. IPEC General Update. IPEC Meetings ICH Q3D Metal Impurities 10/19/2011 DECEMBER 7 TH BOARD OF TRUSTEE MEETING

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1 Update Topics IPEC General Update September 28, 2011 Meeting schedule for 2012 ICH Q3D update ExcipientFest 2012 EXCiPACT ANSI NSF 363 NSF IID update FDA Spectral Library update IPEC Meetings 2012 DECEMBER 7 TH BOARD OF TRUSTEE MEETING WEDNESDAY NIGHT 5:30 Executive Committee 11 5 February May September December 21 Tuesday 14 Monday 24 Monday 3 Monday QbD (am) Exc. Comp (pm) Wednesday Tuesday Tuesday Tuesday GMP (am) Exc. Comp (pm General Update QbD (am) Exc. Comp (pm 23 Thursday 24 Friday 16 Wednesday 17 Thursday 23 Wednesday 24 Thursday 5 Wednesday 6 Thursday ICH Q3D ICH Q3D Metal Impurities Guidance is making progress To Do List Still need data from IPEC members (especially on items with mineral based excipients) or other non Rx products to help drive realistic metal limits Ie toothpaste IPEC is planning on a workshop for 2012 to gather and review additional data PDE ( μg day ) C M W M M M = each ingredient used to manufacture the dosage form C M = element concentration in component M (μg/g) W M = weight of component in the maximum total weight of the drug product administered in a daily dose (g/day) 1

2 Metal Permitted Daily Exposure, μg/day Permitted Concentration, μg/g (assuming 10g maximum dose) As Cd Hg 50 5 Pb 10 1 Al 5000? 500? Ni Co 0 Sn 0 Sb 0 Tl 0 Ba 0 Ag 0 Rh Ru Mo B 0 Ir Os Se 0 Pt Pd Cr V Li Cu Mn Au 0 W ** ** Event History Europe (Ireland) US (Baltimore) 2007 & Asia (China) 2012 Americas (Puerto Rico) EXCiPACT TM Certification Key Milestones for Implementation EXCiPACT TM Certification The process and relationship Development of concept / business plan by EXCiPACT TM GSC April 2011 Cross referenced acceptance of Rx360 and EXiPACT TM by 3.Q Trademark protection by 2Q Acceptance and acknowledgement by IPEC, CEFIC... by 3Q Base funding completed by 90% by 3Q Hiring of staff, establishement of the advisory board by 1.Q 2012 Start of operations by 1Q EXCiPACT TM 3rd Party Audit Organisation Excipient Supplier Excipient user Excipient user Legal Agreement with 3 rd party audit Supplier passes on audit report Agreement with supplier Organisations User can verify audit report and Provides audit report Publish list and list of certificate with EXCiPACT and Certificate TM Certificates / validity on website EXCiPACT TM - Minimise the Risks, Maximise the Benefits 9 EXCiPACT TM - Minimise the Risks, Maximise the Benefits 10 ANSI NSF 363 Excipient GMP 1 st draft written and under review by committee Dale Carter, Dave Klug, Ann VanMeter, Kathie Ulman, Irwin Silverstein, Chris Moreton, Jeff Brambora, Ian Moore, Steve Moss, Sidney Goode January 2012 Public Draft published for comments 2 nd Q 2012 Final Standard Published NSF International A Global Leader in Public Health and Safety Corporate Overview 2

3 A Little History Founded in 1944 to Develop Standards, Certify Equipment Americans began dining out in the late 1930 s. State health officials monitored food service establishments for sanitation using a variety of criteria. Inconsistent rules and regulations arose, varying from town to town, state-to-state. Hence A need for uniform national standards; NSF brings regulators, industry, consumers and public health officials together. NSF was founded as the National Sanitation Foundation in the University of Michigan s School of Public Health in Today, we are known as NSF International, with a corporate headquarters in Ann Arbor, MI, USA, and operations in 120 countries NSF Growth: Organic and Acquisitions Bringing Industry, Regulatory and Consumers Together Launch Foodservice Equipment Program NSF Testing Labs Launch Swimming Pool Safety Launch Plastic Piping Program NSF-ISR launched NSF becomes W.H.O. Collaborating Centre NSF Shanghai & NSF Mexico Davis Fresh acquired CMi acquired (UK, Chile, Peru, Italy, Spain, S. Africa, Czech Republic) David Begg & Associates (UK, Boston) 80,000 sq. ft lab expansion completed 1944 NSF founded Ann Arbor, MI 1950s 1960s 1970s 1980s Develop National Drinking Water Standards Bottled Water Certification NSF Brussels, Belgium opens to serve Europe 1990s Cook and Thurber acquired Launch Dietary Supplement Program QAI acquired NSF Brazil open Deloitte & Touche Quality Registrar acquired (Canada) NSF Thailand & NSF India open NSF Surefish Toy Safety Trucost partner NSF Costa Rica Shanghai Lab NSF Pharmalytica AQA International acquired Industry Food, Water, Consumer Goods Consumers Media, Educators, Consumer Groups Regulators USDA, EPA, FDA, HC, State, Local 16 Today, NSF is a Global Leader in Public Health and Safety NSF Around the Globe Developer of over 72 national consensus standards. Steadfast ties with key associations and govt. agencies. A Collaborating Centre for the World Health Organization. Service provider to thousands of organizations in 120 countries. NSF International Offices Global NSF Partners International Offices Laboratories Global Partners 17 Americas EMEA Asia United States Belgium Poland China Brazil Czech Republic South Africa India Canada France Spain Japan Chile Germany Switzerland South Korea Costa Rica Greece United Kingdom Taiwan Mexico Israel Thailand Peru Italy Turkey Netherlands Vietnam 3

4 An Unmatched Professional Staff and Facility NSF Collaborations 1,200+ experienced professionals: microbiologists, toxicologists, chemist, engineers and public heath experts. 165,000 square feet of state-of-the-art laboratories in Ann Arbor and Shanghai, China, plus partner labs around the world. Innovative Information Technology capabilities. NSF is a World Health Organization Collaborating Centre for: Food Safety Water Safety Drinking Water Quality Guidelines Recreational Water Safety Guidelines Indoor Environment Works closely with International, Federal State and Local Regulators: FDA USDA EPA U.S. Government/Legislature And many more NSF International Accreditations and Certifications Include U.S. Canada Europe NSF Capabilities/Services ISO ISO NSF Core Business Units Food Safety and Quality Services NSF Consumer Dietary Products Supplements Water Food Safety Sustainability /PLA/ / Toy Safety Pharma ISR Food Safety Systems through the supply chain GFSI: SQF, BRC, FSSC 22000, GlobalGAP, IFS Growers, producers, processors, distributors, retailers Produce Safety via NSF Agriculture Field evaluations, testing, consulting and training for growers, processors, distributors and retailers Other Food Safety Systems: HACCP, Tesco Nurture, Tesco Nurture Organic, LEAF Seafood Safety & Quality via NSF Surefish Seafood inspection, testing and consulting (MSC, ACC, HACCP). Processor Safety & Quality Services through NSF Cook & Thurber Consulting/auditing for food, beverage, animal feed and packaging industries. Organic Certification through QAI 4

5 Food Safety and Quality Services Water and Wastewater Systems Major Program Areas Retail Food Safety Services Customized auditing & consulting for restaurants, supermarkets and retail foodservice Foodservice Equipment Certification Nonfood Compounds Registration Beverage Quality Certification Bottled water, packaged ice, flavored water and functional beverages to US FDA & EU Regulations Food Equipment/Nonfood Compounds Cert Food Safety Training and Education Programs classroom, online, video, live webinars and on-site training NSF developed many public health standards adopted by the US EPA to protect drinking water; and standards promoting pool/spa safety. NSF tests and certifies products to those standards: Water Treatment Distribution Components & Chemicals (NSF/ANSI S 60 and 61) Mech. Plumbing Devices (faucets, valves) (NSF/ANSI 61, Sec. 9) Plastic Piping & Components (NSF/ANSI 14) Drinking Water Treatment Units (RO, Softeners, filters, pitchers) (NSF/ANSI Stds 42, 44, 53, 53, 55, 58, 62, 177) Onsite Wastewater Treatment Devices (NSF/ANSI Stds 40, 41, 46 and 245) Recreational Water Pool/Spa Safety (pumps, drains, pool covers, filters) (NSF/ANSI 50) Health Sciences (Dietary Supplements and Pharma) NSF developed the only American National Standard for for Dietary Supplements in 2001 (NSF/ANSI Standard 173). Dietary Supplement l Certification Program GMP audits; Toxicology, Label & Contaminant Reviews Athletic Banned Substance Certification Program: Adds screening for 140 banned substances to the above MLB, NFL,PGA, LPGA, NYPD, and Canadian Centre for Ethics in Sport NSF Pharmalytica GLP and GMP Lab analytical testing, consulting, training, registration and research and development DBA (David Begg Associates) - Pharma Training & Consulting DBA Analytical Biotech, Tox, GMP training Toys & Residential Consumer Products Safety; Protocols NSF is accredited to test and certify toys and children s products to the Consumer Product Safety Improvement Act. NSF develops protocols and standards for residential kitchen items and other household appliances. NSF tests a wide range of consumer products to verify safety, quality and performance. Sustainability and ISO/Strategic Registrations Sustainability Solutions GHG verification Environmental Claims verification Trucost foot printing (carbon, water) ISO (Environmental), R2, RIOS Sustainable ab Forestry Initiative Chain of Custody Strategic Registrations (ISO): ISO 9001 (Quality) ISO (Food Safety) ISO (Information Security) ISO (Medical Devices) And more! NSF s Training and Education: A Cornerstone of NSF s Health-Based Mission NSF s Training and Education Division has a global network of technical experts available to deliver training around the globe for industry, consumers, regulators and pubic health officials. Training forms: online, food safety videos/dvd, guidebooks, live webinars and customized on-site training. Topics: Food Safety & Quality Agriculture Producers, Food and Beverage Processing, Organic Certification, Seafood Safety and Quality, Restaurants and Supermarket Food Safety, Hotel and Hospitality Safety Sustainability, Social Accountability and Environmental management Pharmaceuticals & Dietary Supplements Safety Management Systems/ISO Registration Drinking Water Systems 5

6 Projects with IPEC Host midwest meetings Partner for training programs IPEA joint venture for EXCiPACT / ANSI audits Inactive Ingredient Database (IID) Recent Issues affecting ANDA Sponsors David R. Schoneker Vice Chair of Scientific & Regulatory Policy IPEC Americas Director of Global Regulatory Affairs Colorcon dschoneker@colorcon.com Issues New developments at FDA related to the IID problems for ANDA Sponsors FDA s Substance Registration System (SRS) Impact on the Inactive Ingredient Database Example - HPMC Grade Issue 6

7 Impact to the IID Assessment The SRS nomenclature is being used to add new item listings in the IID which are grade specific with whatever levels happen to be in the NDA or ANDA which triggers inclusion These specific references to the grades are now being used by FDA OGD reviewers as a precedence level when evaluating precedence of use at the Gatekeeper point when a ANDA is filed Many times the levels listed for the specific grades are much lower that what has traditionally been used ANDA sponsors are getting caught in the middle and don t always know which listing to reference, especially for materials where they have been using non-grade specific references with higher levels in the past Triggering refuse to file letters unless additional safety data is provided Impact to the IID Assessment Many times safety data is not readily available from suppliers or the data is old or for a family of materials rather than specific to a grade IPEC Americas is trying to set up a meeting with FDA OGD to discuss solutions to this problem discuss solutions to this problem Discussion and Questions FDA has agreed to meet with IPEC. Date is being determined. Should be established soon! IPEC Regulatory Affairs Committee will be developing the agenda and speaker list for this meeting on Thursday FDA Spectral Library CALL TO IPEC FDA Spectral Library Participation Benefits Butylated Hydroxyanisole Gelatin Povidone Butylated Hd Hydroxytoluene tl Glycerin Pregelatinized Starch Calcium Phosphate (Dibasic) Hydroxy Propyl Cellulose Propylene Glycol (liquid and solid) Calcium Stearate Hydroxy Propyl Methyl Cellulose Shellac Carboxymethyl Cellulose l Lactose Silicon Dioxide Castor Oil Magnesium Stearate Sodium Starch Glycolate Cresol Maltodextrin Sorbitol Croscarmellose Microcrystalline Cellulose Starch (Corn) Crospovidone Polyethylene Glycol, liquid and solid Stearic Acid Ethylcellulose Polysorbate 80 Talc Titanium Dioxide An inspector can make an immediate determination as to whether or not laboratory analysis is necessary by performing a screening test. This approach would reduce delays associated with sending samples to a laboratory. 2. Knowledge that FDA is screening excipients and that excipients are receiving a higher level of scrutiny should provide deterrence and add a layer of difficulty for anyone trying to infiltrate the supply chain. 3. All parties can have an increased level of confidence that the material being identified is indeed from the qualified supplier. 4. Materials that are different from the spectral reference standards can be flagged for additional investigation and, if warranted, subsequently added to the library. 5. All parties will have increased assurance that goods were not tampered with, substituted or otherwise falsified with regard to their origin during distribution. 6. Screening and surveillance activities can enable rapid response to concerns of contamination, adulteration and/or substitution in the supply chain reported to or identified by FDA. 42 7

8 FDA Spectral Library Participation Benefits 1. An inspector can make an immediate determination as to whether or not laboratory analysis is necessary by performing a screening test. This approach would reduce delays associated with sending samples to a laboratory. 2. Knowledge that FDA is screening excipients and that excipients are receiving a higher level of scrutiny should provide deterrence and add a layer of difficulty for anyone trying to infiltrate the supply chain. 3. All parties can have an increased level of confidence that the material being identified is indeed from the qualified supplier. 4. Materials that are different from the spectral reference standards can be flagged for additional investigation and, if warranted, subsequently added to the library. 5. All parties will have increased assurance that goods were not tampered with, substituted or otherwise falsified with regard to their origin during distribution. 6. Screening and surveillance activities can enable rapid response to concerns of contamination, adulteration and/or substitution in the supply chain reported to or identified by FDA. IPEC FDA QbD Excipient Workshop White Oak December 5 th 9am Noon Speakers Brian Carlin (FMC) Dave Schoneker (Colorcon) ChrisMorton (FinnBrit Consulting) Graham Cook (Pfizer possibly by videoconference if he cannot attend) Tom Schultz (J&J) FDA perspective Others other 43 Agenda Introduction to IPEC and IPEC Guideline Types and Sources of Excipient Variability Performance related properties (compositional and physical) Limitations of possible controls in chemical plants Communication between maker and user P d i tti f i i t Proper design space expectations for excipients Misunderstandings of what types of samples will be available for experimentation Concepts for design space development Advanced concepts for future improvements Panel discussion Q&A 8

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