Who is USP
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Who are our Expert Volunteers
?A hallmark of USP’s standards is that they are determined by independent scientific experts. USP Expert Volunteers are selected based on their individual expertise and experience and use their best personal, professional, and scientific judgment to work collaboratively on setting standards. USP Expert Volunteers must agree to disclose conflicts of interest and to uphold standards of conduct that preserve the integrity of the standard setting process
.
Chair Responsibiliti
- esLeads, listens, and builds consensus among committee membe
- rsElects Expert Committee (EC) Members through their Council of Experts (CoE) ro
- leChairs and leads an
- ECEnforces standards of conduct as expressed in USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethics
- Participates in Collaborative Group discussio
- nsLeads Chair succession planning and develops “next generation” of voluntee
- rsServes as the face of the
- ECAdministers the EC’s Work Pl
- anReviews disclosure statements and manages conflicts of intere
- stPrepares for meetings by working with USP staff to develop meeting agenda and briefing materials; manages meeting agenda, including meeting closure, facilitates EC meeting and discussion; and focuses on and summarizes outcom
- esAdopts the Rules and Procedures of the 2025-2030 Council of Experts (CoE Rule
- s)Approves General Notices and General Chapter <11> USP Reference Standar
- dsParticipates in the adjudication of appea
- lsRecommends the number and types of ECs for the next cyc
- leAppoints new/replacement EC Chairs through CoE ro
- leConsiders long-term implications of activities on U
- SPFulfills all duties of an EC Memb
er
Chair Qualificat
- ionProven track record of effective leadership within the pharmaceutical / food / dietary supplement & herbal medicines industry or related fields, demonstrating the ability to guide and inspire diverse teams towards achieving common objectiv
- es.Strong communication and interpersonal skills, essential for fostering collaboration, facilitating discussions, and building consensus among committee membe
- rs.Experience in strategic planning and decision-making, with the capability to navigate complex challenges and drive initiatives aligned with USP's mission and goa
- ls.Commitment to upholding the highest standards of integrity, ethics, and professionalism, serving as a role model for ethical conduct and accountability within the committee and broader communi
- ty.Ability to represent the EC’s interests and perspectives within USP's governance structure, advocating for the adoption of evidence-based standards and best practic
- es.Capacity to effectively manage time and resources, ensuring the efficient operation of the committee and timely completion of assigned tasks and deliverabl
- es.Dedication to ongoing learning and professional development, staying abreast of relevant industry trends, regulatory requirements, and emerging technologies to inform the committee's work and recommendatio
- ns.Strong understanding of USP’s Standard Setting Proc
- essIn addition to possessing relevant scientific expertise, the Chair plays a unique and critical role in fostering a collaborative team culture, facilitating open scientific dialogue, developing the next generation of volunteers, and driving towards standards and solutions that are relevant and useful to our stakeholders. In this respect, the Chair upholds, models, and helps ensure adherence to USP’s Code of Ethics, Rules & Procedures of the Council of Experts, Standards of Conduct, and Commitment to Diversity, Equity, Inclusion and Belonging. Part of our commitment to DEIB includes the expectation of inclusive management during the Committee meetings, promoting diversity, and actively interrupting bias. These practices are essential to the quality of scientific work and to the success of U
SP.
About General Chap
tersGeneral Chapters is responsible for many critical areas in pharmaceutical quality chemical analysis, material physical properties characterization, microbiological quality, dosage forms, packaging and distribution of pharmaceutical products, pharmaceutical analysis lifecycle and scientific data quality and statistics in pharmaceutical development. These focus areas will be developing standards that are relevant in an evolving global environment. This impacts pharmaceutical development and production in all its phases and requires engagement across global regulators, industry, and other stakehold
ers.
Key Issues for General Chap
- ters:Development of General Chapters standards for Industry 4.0: including but not limited to PAT, Chemometrics, environmentally friendly analytical techniques and Impurities, real-time release tes
- ting.Quality and performance tests for all types of dosage forms and complex prod
- ucts.Pharmaceutical continuous manufact
- uringMaterial physical properties characteriz
- ationParticle size and shape measurement techn
- iquesNanomaterial analytical characteriz
- ationEndotoxins and pyrogens tests, to reduce the use of animals and reagents derived from ani
- mals.In-process biob
- urdenModern microbiological me
- thodsTransport and distribution: route profiling qualifica
- tion.Qualification of shipping conta
- inersTemperature mapping of the storage
- areasMean Kinetic Temperature
- (MKT)Particulate control of packaging materials and sy
- stemsExtractables and leachables: Packaging sy
- stemsAnalytical procedures quality risk manag
- ementBio
- assayAnalytical procedure comparab
- ilitySampling techniques and proce
dures
Focus
Areas Click here for require
ments.Dosage
- FormsQuality and performance tests for all types of dosage
- formsComplex products such as complex injectables, ophthalmics, topicals & transdermal, nasal & inhalation pro
ducts.Chemical An
- alysisAutomation of analytical tech
- niquesSpectroscopic tech
- niquesProcess analytical technology, Real time release t
- estingLife-cycle approach of analytical techno
- logiesDigital applications in analytical tech
- nologyData integrity and data gove
- rnanceGC reference standard devel
- opmentImpurities characterization, including inorganic, organic and mutagenic (extractables and leach
- ables)Risk-based appr
oachesMicrob
- iologyRapid/Modern Microbiological M
- ethodsMonocyte Activation Test, replacement tests for the Rabbit Pyroge
- n TestIn-process bio
- burdenMicrobiological contamination control st
- rategySterility Ass
- uranceSterili
zationPackaging and Distri
- butionPackaging sustainability, Recycled plastic materials, Biodegradable and sustainable packaging mat
- erialsGood Distribution Practices (GDP), Temperature control management, Temperature excursion management, Temperature mapping, Distribution packaging
- systemPackaging suitability, Biocompatibility, Polymer chemistry, Glass quality, Extractable and Leac
hablesStat
- isticsUniformity of Dosage units; Content Uniformity for Large S
- amplesStatistical Quality c
- ontrolSampling proc
- eduresAnalytical Procedure Equiv
- alencyBi
- oassayMultivariate data an
alysisPharmaceutical Analysis Lifecycle – Data S
- cienceAnalytical Procedures Lif
- ecycleChemom
- etricsOngoing procedure performance verification, statistical tools for process/procedure performance monitoring (multivariate and univariate proce
- dures)Measurement Uncertainty and Total Analytical Error – role throughout procedure lif
- ecycleAnalytical Instrument Qualifi
cationMaterials Physical Properties Characteri
- zationStandards and guidelines for analytical procedures for the material’s physical properties characterization and quality control, including the input and in-process materials (e.g., particles, powders, liquids, slurries) used in the manufacturing of a drug product and/or its components (excipients, drug substance,
etc.)
Volunteer Time Requ
- irementMust be able to contribute average of 5 hours per week with some va
- riationMeetings: 1 to 2 face-to-face official meetings per fisc
- al yearTeleconferences held as needed for official meetings and working s
essions
Travel Req
uirementMust be able to attend two (2) in-person collaborative meeting at USP Headquarters in Maryland, US, Brazil, China, or India per fiscal year; minimum of 3 in-person attendance per 5-ye
ar cycle
