USP Update - BioIN
USP UpdateAnthony Tann, Jennifer DerryJune 20, 2019
Agenda USP Priorities for South Korea Chemical Medicines Biologics Dietary Supplements/Herbal Medicines USP Convention 20203 2018 USP
USP – Building Trust for almost 200 years4 2018 USP
USP - Global reach to advance qualityOur standards are legallyrecognized in over 50 countriesand 160 utilize our standards Our collective knowledge of peoplearound the world Beyond lab operations– Regulatory affairs– Strategic customer development– Public Health Build team for stakeholder engagementfor government and industry drivenimpact5 2018 USP
USP helps protect patients and supports access to quality medicines Independent, not-for-profit organization, selffunded Strengthening systems to ensure access toquality medicines Technical assistance to regulatory agencies to perform criticalfunctions, including dossier evaluation and marketauthorization, inspections, post-marketing surveillance, andtesting and quality control of medical products Supporting manufacturers to increase thesupply of quality medicines End-to-end support for manufacturers to implement strongquality systems, identify and address corrective actions, filedossiers for product approval, and prepare for inspections.
Asia is a diverse mix of developed, maturing and emerging marketsEmergingDeveloped 0005003886MalSG00IndoPhilVNTH*Based on current US exchange rateSource: WHO, World Bank, Euromonitor, IQVIA Market Prognosis Q3 2018; IQVIA analysisJPKRHealthcare expenditure per Capita (USD)4047264Population (mil) 4500Innovation and thought leadership inquality standards development fornew therapies– Biotherapeutics– Advanced therapiesMaturing and Emerging Markets Capability building and education– Pre-market development insystem maturing– Strengthening in product quality– Post market safety surveillance7 2018 USP
USP – Korea: A Rich History of Bilateral Cooperation since2012 USP hosted the MFDS officers from Korea in ChemicalMedicines, Food Fraud Database; short term VisitingScientist Program, Herbal Medicines Scientific collaboration begun with executive exchangeresident resulted in two chemical medicine monographdonations from Korean companies and laid thegroundwork for further collaboration Emerging biopharma in Korea opens furtheropportunities for scientific collaboration with biologicals– Two members from Korea (one from NIFDS and twofrom industry) were part of the Biologics ExpertMembers Education programs to build regulatory capacity andtrain manufacturers Identify standards are needed by both USP and Koreaand jointly develop one to three standards8 2018 USP
Collaboration with USP in safeguarding the quality of biologicalmedicines USP will promote alignment with all stakeholders to developquality standards for biological medicines– Standards to facilitate quality throughout the productlifecycle, from development and manufacturing all theway to the patient– Continue to modernize standards for legacy biologicalproducts– Performance standards for peptides, therapeuticproteins, cell and gene therapies etc. Advancing impact on biologics through a combinedapproach with focus on :– Roundtables, workshops– Expert panels and committees– Education9– Collaborations and partnerships in studies / development 2018 USP
USP approach to development of standards Support biologics analytical testing throughout the product lifecycle Used to ensure and demonstrate methods and process performance Broadly targeted at product families or classes10 2018 USP
USP Priorities for South KoreaStrengthen relationship with NIFDS/MFDS Memorandum of Understanding since 2012– Standards Development Esomeprazole strontium On-going: Gemifloxacin– Collaborative Testing Laboratory– Advocacy and Awareness Joint scientific symposium– Training and Capacity Building Participate in expert committees and expert panels Short and Long term scientific exchange programs Future Activities Increased focus on support to industry – especially in biologics Increased collaboration between NIFDS, manufacturer’s associations and USP11 2018 USP
USP Priorities for South KoreaStrengthen relationship with other stakeholders KOBIA and KPBMA– Newly invited as observers to USP Convention KDRA (Korean Drug Research Association) and KHSA (Korean Health SupplementAssociation) Industry Members12 2018 USP
Biologics Conduct 1-2 technical round table discussions with manufacturers to address whereUSP can provide support in product development and testing processes Meet with NIFDS Biologics reviewers once a year to hold technical discussions onconcerns and hurdles on biologics assessments and where USP can provide support13 2018 USP
Chemical Medicines Establish NIFDS as a collaborative testing lab for USP– Pilot with two countries: Russia and Korea– ISO 17025 Accreditation requirement Monograph and reference standard collaboration with industry– Priority list on usp.org1. tion-priority-new-monograph-lists14 2018 USP
Dietary Supplements/Herbal Medicines Conduct 1-2 stakeholder forums for knowledge sharing of work USP conducts in thedietary supplement and herbal medicines space Further collaborate with NIFDS and industry association to schedule trainings/courseson various topics – for example: GMP requirements Co-develop monographs for herbal medicines to be listed in HMC – Herbal MedicinesCompendium Monograph and reference standard collaboration with industry– Priority list on usp.org– tion-priority-new-monograph-lists15 2018 USP
Collaboration with Industry New Standards– Contributions from industry may be in forms of monographs and general chapters Revised Standards– in order to stay current with changes in industry, you may submit current analyticalprocedures and supporting validation data, or– Submit small amounts of materials to assist in USP standards development For further guidelines:– -guidelines16 2018 USP
Volunteers Make it Happen at USP18 2018 USP
Volunteers Make it Happen at USP Examplesof Expert Panels 825 RadiopharmaceuticalsCompounding ChapterExchange of Compounded DrugPreparation Information in HealthIT SystemsUse of Enzymes in theDissolution Testing of GelatinCapsulesHerbal Medicines Compendium East AsiaOlive Oil Authenticity andQualityPerformance Test for SemisolidDosage FormsCannabisInsulinBioassay General ChapterHerbal Medicines Compendium South Asia 381 Elastomeric Closure forInjectionsNew Advancements in ProductPerformance TestingFood AdulterationHQ - Parenteral Nutrition Safety 771 Ophthalmic PreparationsProbioticsHQ - USP Drug ClassificationElemental ImpuritiesPronunciation ProjectHoney Expert PanelGlatiramerHQ - Drug Allergy and IntoleranceClassificationHQ - Health Literacy 660 Containers-Glass ExpertPanel19 2018 USP
2017 USPUSP–NF Online: Changes to Title and Format One subscription for 20 users USP will discontinue printing the USP–NF in the current format. The USP43–NF 38 edition will be the last printed edition available - Nov 2019 USP 43 Supplement online only – May2020 USP 44 will be online only – USP NF 20212020 2018 USP
2017 USP2121 2018 USP
Thank You
Phone Social Media Email
–Strategic customer development –Public Health Build team for stakeholder engagement for governm
USP Reference Standards for USP or NF. section, under Quantitative determinations, the text is revised as follows: ”For the USP Reference Standards where an International Standard (IS) established by the WHO exists, the reference standards documentation will indicate when the USP RS has been established by
Y-site compatible with several IV bag fluids, including: — Water for Injection, USP — 0.9% Sodium Chloride Injection, USP — Lactated Ringer’s Injection, USP — 10% Amino Acid — 5% Dextrose Injection, USP — 5% Dextrose in 0.9% Sodium Chloride Injection, USP — 5% Dextrose in Lactated Ringer’s Injection, USP Titrate DOSE .
Current state of USP 797 June 1 st, 2019 - Revised USP 797 and new 800 guidelines published September 23 rd, 2019 - USP 797 is postponed until further notice 2008 revision is the only enforceable guideline published to date March 12 th, 2020 - Appeals panel remands USP 797 and 795, 800 is purely informational
DSC USP–NF General Chapters25 USP–NF General Chapters This section contains selected official general chapters that are reprinted from the USP.Only those USP chapters considered relevant for the analysis and/or manufacturing of dietary supplements are included in this section.
Apr 08, 2021 · About United States Pharmacopeia (USP) USP, a scientific organization that sets standards for identity, strength, quality, and purity of medicines, food ingredients, and . Follow containment requirements in USP 800 Perform an Assessment o
Elemental Impurities Complies with USP 232 limits USP 233 Bioburden TAMC TYMC 1000 CFU/g 100 CFU/g USP 61 (membrane filtration method) Bacterial Endotoxins (LAL) To be determined (based on maximum allowed exposure limit, e.g., 5 EU/kg/hr for IV) USP 85 Preliminary Specifications for Peptide APIs (Continued)
The first United States Pharmacopeia (USP) was published. 1938 1975 2020 200 years of building trust USP purchased the NF, combining the two publications under one cover to create the United States Pharmacopeia-National Formulary (USP-NF). The Federal Food, Drug, and Cosmetic Act expands the roles for applicable USP and
USP 1058 The USP is the only major pharmacopoeia to have a general chapter on AIQ, so many companies use the approach as a basis for qualifying their analytical instruments. USP 1058 is an important document as it is the only risk-based regulatory guidance on the subject. USP 1058 is an informational general chapter (providing strong .
