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. USP is committed to adopting more environmentally sustainable quality testing practices, manufacturing technologies, and health care actions across the pharmaceutical lifecycle.
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. USP Expert Volunteers work under a policy to foster a more sustainable environment, creating and revising standards toward reduction of energy consumption, minimization of toxic waste, reduction of animal testing, and water conservation.
Member Responsibilities
- Reads and abides by USP’s Bylaws, rules, and policies, including CoE Rules and the USP Code of Ethics
- Participates in meetings (reads briefing materials, attends meetings, reviews minutes and notes, etc.) and notifies USP staff of conflicts of interest
- Approves USP standards through balloting and voting (USP–NF, Reference Standards)
- Commits to understanding of USP’s Mission
- Advocates for and represents USP and its future
- Handles confidential information properly
- Considers regulatory framework
- Challenges constructively
- Commits time and effort to participate in EC activities
- Disposes of any confidential materials at the conclusion of service
- Commits to development of standards with positive impact on the environment.
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. This includes updating and improving USP standards with the aim to have state of art analytical technologies that are efficiently suited for regulatory purposes and environmentally friendly. 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
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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.)
Key Issues/Goals
- Bioassay
- Analytical procedure comparability
- Sampling techniques and procedures
Volunteer Time Requirement
- Must be able to contribute average of 3.55 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.
