USP General Chapters - Chair

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 Responsibilities

• Leads, listens, and builds consensus among committee members
• Elects Expert Committee (EC) Members through their Council of Experts (CoE) role
• Chairs and leads an EC
• Enforces 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 discussions
• Leads Chair succession planning and develops “next generation” of volunteers
• Serves as the face of the EC
• Administers the EC’s Work Plan
• Reviews disclosure statements and manages conflicts of interest
• Prepares 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 outcomes
• Adopts the Rules and Procedures of the 2025-2030 Council of Experts (CoE Rules)
• Approves General Notices and General Chapter <11> USP Reference Standards
• Participates in the adjudication of appeals
• Recommends the number and types of ECs for the next cycle
• Appoints new/replacement EC Chairs through CoE role
• Considers long-term implications of activities on USP
• Fulfills all duties of an EC Member

Chair Qualification

• Proven 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 objectives.
• Strong communication and interpersonal skills, essential for fostering collaboration, facilitating discussions, and building consensus among committee members.
• Experience in strategic planning and decision-making, with the capability to navigate complex challenges and drive initiatives aligned with USP's mission and goals.
• 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 community.
• Ability to represent the EC’s interests and perspectives within USP's governance structure, advocating for the adoption of evidence-based standards and best practices.
• Capacity to effectively manage time and resources, ensuring the efficient operation of the committee and timely completion of assigned tasks and deliverables.
• 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 recommendations.
• Strong understanding of USP’s Standard Setting Process
• In 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 USP.

About General Chapters

General 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 stakeholders.

Key Issues for General Chapters:

• 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 testing.
• Quality and performance tests for all types of dosage forms and complex products.
• Pharmaceutical continuous manufacturing
• Material physical properties characterization
• Particle size and shape measurement techniques
• Nanomaterial analytical characterization
• Endotoxins and pyrogens tests, to reduce the use of animals and reagents derived from animals.
• In-process bioburden
• Modern microbiological methods
• Transport and distribution: route profiling qualification.
• Qualification of shipping containers
• Temperature mapping of the storage areas
• Mean Kinetic Temperature (MKT)
• Particulate control of packaging materials and systems
• Extractables and leachables: Packaging systems
• Analytical procedures quality risk management
• Bioassay
• Analytical procedure comparability
• Sampling techniques and procedures

Focus Areas

Click here for requirements.

Dosage Forms

• Quality and performance tests for all types of dosage forms
• Complex products such as complex injectables, ophthalmics, topicals & transdermal, nasal & inhalation products.

Chemical Analysis

• Automation of analytical techniques
• Spectroscopic techniques
• Process analytical technology, Real time release testing
• Life-cycle approach of analytical technologies
• Digital applications in analytical technology
• Data integrity and data governance
• GC reference standard development
• Impurities characterization, including inorganic, organic and mutagenic (extractables and leachables)
• Risk-based approaches

Microbiology

• Rapid/Modern Microbiological Methods
• Monocyte Activation Test, replacement tests for the Rabbit Pyrogen Test
• In-process bioburden
• Microbiological contamination control strategy
• Sterility Assurance
• Sterilization

Packaging and Distribution

• Packaging sustainability, Recycled plastic materials, Biodegradable and sustainable packaging materials
• Good Distribution Practices (GDP), Temperature control management, Temperature excursion management, Temperature mapping, Distribution packaging system
• Packaging suitability, Biocompatibility, Polymer chemistry, Glass quality, Extractable and Leachables

Statistics

• Uniformity of Dosage units; Content Uniformity for Large Samples
• Statistical Quality control
• Sampling procedures
• Analytical Procedure Equivalency
• Bioassay
• Multivariate data analysis

Pharmaceutical Analysis Lifecycle – Data Science

• Analytical Procedures Lifecycle
• Chemometrics
• Ongoing procedure performance verification, statistical tools for process/procedure performance monitoring (multivariate and univariate procedures)
• Measurement Uncertainty and Total Analytical Error – role throughout procedure lifecycle
• Analytical Instrument Qualification

Materials Physical Properties Characterization

• Standards 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 Requirement

• Must be able to contribute average of 5 hours per week with some variation
• Meetings: 1 to 2 face-to-face official meetings per fiscal year
• Teleconferences held as needed for official meetings and working sessions

Travel Requirement

Must 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-year cycle

Language Proficiency

While USP operates primarily in English, our Expert Volunteers come from all over the world and speak multiple languages. While most LIVE business meetings are conducted in English, much of the work for the Expert Scientist includes reading, reviewing, and writing in Technical English. Proficiency in written English is required. Effective verbal communication may be facilitated by technology and written pre-read materials. Encourage application even if English is not the native spoken language but are proficient in reading and writing in Technical English. For more information on English Proficiency requirements, please refer to this link.