2010-2015 USP Expert Committees and Their Focus Areas_ Roles_ and by dfgh4bnmu

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									                           2010-2015 USP Expert Committees and Their Focus Areas, Roles, and Expertise Required
                                                                  Revised January 2010

   USP invites qualified candidates – pharmaceutical scientists, academicians, regulatory professionals, healthcare professionals, and others – to apply
   to serve as scientific decision makers on the Council of Experts and its Expert Committees. The 2010-2015 Council of Experts includes 20 Expert
   Committees in the areas of Nomenclature, Small Molecules, Biologics and Biotechnology, Excipients, General Chapters, Reference Standards,
   Compounding, Food Ingredients, and Dietary Supplements, with each member of the Council of Experts chairing an Expert Committee.

   The following information describes the Expert Committees for which USP is seeking candidates, its focus areas, its roles and responsibilities, and the
   expertise required of potential applicants.


       Expert Committee                   Focus Areas                   Expert Committee Roles                             Expertise Required
      01. Monographs—            Antibiotics                Develop new and revise existing monographs      Expertise in analytical chemistry including
      Small Molecules 1          Antimicrobials              and their associated reference standards for     wet chemistry techniques, compendial tests,
                                 Antivirals                  drug substances and dosage forms.                chromatography, spectroscopy, dissolution
                                                                                                               testing and/or microbiological tests (e.g.,
                                                                                                               microbial limits, bacterial endotoxins, sterility,
                                                                                                               etc).
                                                                                                              Expertise in antibiotics microbial assays.
                                                                                                              Expertise with regulatory requirements
                                                                                                              Expertise with the qualification and use of
                                                                                                               reference materials.
      02. Monographs—            Cough, Cold                Develop new and revise existing monographs      Expertise in analytical chemistry including
      Small Molecules 2          Analgesics                  and their associated reference standards for     wet chemistry techniques, compendial tests,
                                 Cardiovascular              drug substances and dosage forms.                chromatography, spectroscopy, dissolution
                                                                                                               testing and/or microbiological tests (e.g.,
                                                                                                               microbial limits, bacterial endotoxins, sterility,
                                                                                                               etc).
                                                                                                              Expertise in non-prescription drugs
                                                                                                              Expertise with regulatory requirements
                                                                                                              Expertise with the qualification and use of
                                                                                                               reference materials.
      03. Monographs—              Gastrointestinal         Develop new and revise existing monographs      Expertise in analytical chemistry including
      Small Molecules 3            Renal                     and their associated reference standards for     wet chemistry techniques, compendial tests,
                                   Endocrine                 drug substances and dosage forms.                chromatography, spectroscopy, dissolution
                                   Ophthalmology                                                              testing and/or microbiological tests (e.g.,
                                   Oncology                                                                   microbial limits, bacterial endotoxins, sterility,
                                   Dermatology                                                                etc).
                                   Veterinary                                                                Expertise in development and/or testing of
                                                                                                               veterinary pharmaceuticals
                                                                                                              Expertise with regulatory requirements
                                                                                                              Expertise with the qualification and use of
                                                                                                               reference materials.
P:\03 Council of Experts\CoE 2010-2015\Expert Committees
                           2010-2015 USP Expert Committees and Their Focus Areas, Roles, and Expertise Required
                                                                 Revised January 2010

       Expert Committee                    Focus Areas                 Expert Committee Roles                             Expertise Required
      04. Monographs—              Psychoactives           Develop new and revise existing monographs      Expertise in analytical chemistry including
      Small Molecules 4            Psychiatrics             and their associated reference standards for     wet chemistry techniques, compendial tests,
                                   Pulmonary/Aerosols       drug substances and dosage forms.                chromatography, spectroscopy, dissolution
                                   Steroids                                                                  testing and/or microbiological tests (e.g.,
                                   Radiopharmaceuticals                                                      microbial limits, bacterial endotoxins, sterility,
                                                                                                              etc).
                                                                                                             Expertise in aerosol performance testing and
                                                                                                              container closure systems
                                                                                                             Expertise with regulatory requirements
                                                                                                             Expertise with the qualification and use of
                                                                                                              reference materials.
      05. Monographs—            Glycosaminoglycans and    Develop new and revise existing monographs      Expertise in analytical biochemistry,
      Biologics and               Heparins                   and their associated reference materials for     immunology and biological potency
      Biotechnology 1            Peptides/Hormones          biological medicines.                            determination related to biological
                                 Enzymes                                                                     medicines.
                                 Therapeutic Proteins                                                       Expertise in pharmaceutical quality control,
                                 Monoclonal Antibodies                                                       compliance, and analytical characterization
                                                                                                              testing.
                                                                                                             Expertise with regulatory requirements
                                                                                                             Expertise with the qualification and use of
                                                                                                              reference materials.
      06. Monographs—            Vaccines                  Develop new and revise existing monographs      Expertise in vaccine manufacturing and
      Biologics and              Cell-based Therapies       and their associated reference materials for     analysis, immunology, virology testing and
      Biotechnology 2            Plasma Derivatives         biological medicines.                            biological potency determination related to
                                 Tissue Therapies                                                            the above biological medicines.
                                  Monographs                                                                 Expertise in pharmaceutical quality control,
                                 Gene Therapy                                                                compliance, and analytical characterization
                                 Potency Assays                                                              testing.
                                                                                                             Expertise with regulatory requirements
                                                                                                             Expertise with the qualification and use of
                                                                                                              reference materials.
                                                                                                             Expertise in raw, process, and ancillary
                                                                                                              materials qualification
      07. Monographs—            Excipients—Simple         Develop new and revise existing monographs      Expertise in the areas of analytical chemistry
      Excipients                 Excipients—Complex         and their associated reference materials for     and manufacturing related to simple and
                                                             simple and complex excipients                    macromolecular pharmaceutical ingredients.
                                                                                                             Expertise with regulatory requirements
                                                                                                             Expertise with the qualification and use of
                                                                                                              reference materials.



P:\03 Council of Experts\CoE 2010-2015\Expert Committees
                           2010-2015 USP Expert Committees and Their Focus Areas, Roles, and Expertise Required
                                                                          Revised January 2010

       Expert Committee                     Focus Areas                        Expert Committee Roles                               Expertise Required
      08. Monographs—              Vitamins and Minerals           Develop new and revise existing monographs        Expertise in manufacturing, analytical
      Dietary Supplements          Botanical Drugs                  and their associated reference materials for       chemistry, pharmacognosy, or toxicology
                                   Phytomedicines                   dietary supplement ingredients and products.       related to dietary supplements and/or dietary
                                   Traditional Medicines                                                               ingredients and botanical drugs/traditional
                                   Aminoacids                                                                          medicines.
                                   Articles of Botanical Origin                                                       Expertise with regulatory requirements
                                                                                                                       Expertise with the qualification and use of
                                                                                                                        reference materials.

      09.Compounding             Human Drug Compounding            Develop new and revise existing human and         Expertise in a) formulating and compounding
                                 Veterinary Drug                    veterinary compounded preparation                  sterile and non-sterile preparations b)
                                  Compounding                        monographs.                                        evaluating process development and stability
                                 Radiopharmaceuticals              Revise and update current General Chapters         data related to compounded
                                  CompoundingCompounding             that pertain to the compounding of                Expertise with regulatory requirements
                                  Flavorings                         extemporaneous non-sterile and sterile            Expertise with the qualification and use of
                                                                     preparations.                                      reference materials.
                                                                    Develop and approve additional content for the
                                                                     USP Pharmacists’ Pharmacopeia.
      10. Monographs—              Food Ingredients                Develop new and revise existing monographs        Expertise in food chemistry, food technology,
      Food Ingredients             Contaminants/Adulterants         and their associated reference materials for       food toxicology, food manufacturing, food
                                   Flavors and Extracts             food ingredients.                                  regulatory affairs or analytical chemistry.
                                   Additives                                                                          Expertise with regulatory requirements
                                   Colorants                                                                          Expertise with the qualification and use of
                                                                                                                        reference materials.
      11. General                Spectroscopy                      Develop new and revise existing General           Expertise in spectroscopy (e.g., MS, NMR,
      Chapters—Chemical          Chromatography                     Chapters related to chemical analysis (e.g.,       IR, NIR, UV, Fluorescence, AA, ICP, XRF or
      Analysis                   Dietary Supplement Tests           chromatography, spectroscopy, metal or water       hyphenated techniques), chromatography
                                  and Assays                         analysis).                                         (e.g., HPLC, TLC, CE), thermal analysis,
                                 Metal Analysis                    Develop new General Chapters to assure the         classical techniques for functional-group
                                 Pharmaceutical Waters              compendia include technologies that will           analysis, food analysis and dietary
                                 Classical Wet-chemical Tests       become accepted industry practice over the         supplement analysis (e.g., vitamin, mineral
                                  and Assays                         next several years                                 or botanical supplement analysis) or
                                 Food Ingredients Tests and                                                            experience in compendial issues related to
                                  Assays                                                                                water quality.
                                                                                                                       Expertise in tests or methods of assay in
                                                                                                                        settings involving the demonstration
                                                                                                                        of compliance with FDA current Good
                                                                                                                        Manufacturing Practices, (identity, strength,
                                                                                                                        quality and purity).



P:\03 Council of Experts\CoE 2010-2015\Expert Committees
                           2010-2015 USP Expert Committees and Their Focus Areas, Roles, and Expertise Required
                                                                          Revised January 2010

       Expert Committee                   Focus Areas                          Expert Committee Roles                                 Expertise Required
      12. General                Tests related to excipient         Develop new and revise existing General          Expertise in classical physical measurement
      Chapters—Physical           performance (e.g., density,         Chapters related to physical analysis.            techniques, excipient performance
      Analysis                    rheology, flow characteristics)                                                      characteristics and their effects on
                                 Particle size determination                                                           manufacturing processes, pharmaceutical
                                 Classical Physical                                                                    compounding, writing, or review or
                                  Measurement Tests                                                                     implementation of regulatory guidances and
                                 Industry Guidances (e.g.,                                                             an understanding of their genesis and
                                  Manufacturing Practices, Bulk                                                         impact.
                                  Excipients, Analytical                                                               Expertise in demonstrating compliance with
                                  Instrument Qualification,                                                             FDA current Good Manufacturing Practices,
                                  Validation, Verification,                                                             (identity, strength, quality and purity).
                                  Stability, Harmonization)
      13. General                Proteins                           Develop new and revise existing General          Expertise in cell-based assays,
      Chapters—Biological        Glycoproteins                       Chapters related to biological molecules,         immunochemistry, physicochemical
      Analysis                   Polysaccharides                     ancillary materials and reagents, and product     characterization of proteins and natural
                                 Blood Products                      monographs.                                       products, virology, immunology, vaccines, or
                                 Cell, Gene and Tissue-             Develop technique-based General Chapters as       the development or manufacturing of
                                  Engineered Products                 needed to contain key technologies supporting     biologics.
                                 Vaccines and Virology               multiple product monographs.                     Expertise in tests or methods of assay in
                                 Bioassays                                                                             settings involving the demonstration
                                 Immunoassays                                                                          of compliance with FDA current Good
                                                                                                                        Manufacturing Practices, (identity, strength,
                                                                                                                        quality and purity).
      14. General                Routes of Administration:          Develop new and revise existing General          Expertise in the development and testing of
      Chapters—Dosage              o Oral                             Chapters and default-monograph General            drug products for quality and performance.
      Forms                        o Parenteral                       Chapters related to pharmaceutical dosage         Specific expertise includes BA/BE testing,
                                   o Inhalation                       forms.                                            dissolution testing, formulation design and
                                   o Transdermal/Topical                                                                testing, medical gas testing, and testing of
                                   o Mucosal                                                                            performance of parenterals, aerosols,
                                                                                                                        ophthalmic solutions, patches, topicals, as
                                                                                                                        well as expertise in veterinary and
                                                                                                                        radiochemical applications.




P:\03 Council of Experts\CoE 2010-2015\Expert Committees
                           2010-2015 USP Expert Committees and Their Focus Areas, Roles, and Expertise Required
                                                                         Revised January 2010

       Expert Committee                      Focus Areas                       Expert Committee Roles                                 Expertise Required
      15. General                  Microbiology                   Develop new and revise existing General             Expertise in relevant compendial areas such
      Chapters—                    Rapid Microbiology              Chapters and General Information Chapters            as, classical Microbiology, Sterility
      Microbiology                 Sterility Assurance             related to Microbiology and Sterility Assurance.     Assurance, and familiarity with current
                                   Bacterial Endotoxins           Evaluate Sterility assurance, Bacterial              industrial and regulatory trends in these
                                                                    Endotoxins and Microbial Quality requirements,       areas, including, automated / rapid
                                                                    relative to new monograph development and            technologies.
                                                                    revisions.                                          Expertise in tests performed in settings
                                                                   Lead in the evaluation of rapid microbiological      involving the demonstration of compliance
                                                                    methodology and other upstream methodology           with FDA current Good Manufacturing
                                                                    as they relate to compendial activities              Practices, (identity, strength, quality and
                                                                                                                         purity).
      16. General                Packaging (Anti-                 Develop new and revise existing General             Expertise in packaging, storage or
      Chapters—Packaging,         Counterfeiting, Extractables/     Chapters related to packaging (container-            distribution of drug substances, drug
      Storage, and                Leachables)                       closure systems), storage or distribution of         products, excipients, dietary supplements or
      Distribution               Storage and Stability             pharmaceutical ingredients or dosage forms.          food ingredients.
                                 Distribution and Cold Chain      Develop new General Chapters in the areas of        Expertise in the areas of anti-counterfeiting
                                  Storage                           anti-counterfeiting, supply-chain management,        technologies and
                                 Shipping Requirements             packaging extractables and leachables, and           packaging.extractables/leachables analysis
                                 Temperature Control               storage temperature control.                         and control.
      17. Nomenclature,          Drug Product Nomenclature        Review and approve monograph titles                 Familiarity with nomenclature issues
      Safety, and Labeling       Food and Excipients              Review new dosage forms appearing on the             regulations, and policies.
                                  Nomenclature                      market                                              Familiarity with current marketplace products
                                 Dietary Supplements              Implement/develop nomenclature policies              in respective focus areas.
                                  Nomenclature                     Develop and approve content for USP                 Expertise in healthcare fields related to
                                 Biologics/Biotechnology           Dictionary                                           patient safety, health literacy, and labeling.
                                  Nomenclature                     Patient safety aspects of drug labeling
                                 Safe Medication Use
                                 Prescription Labeling
      18. Reference              Reference Standard decision-     Develop guidelines that align with best             Expertise in analytical methods and data
      Standards                   making framework and              practices for the development of reference           evaluation.
                                  guideline development for         materials.                                          Understanding of the regulatory aspects of
                                  small molecules, biologics       Periodically review guidelines to assure             reference materials and certified reference
                                  and biotechnology, dietary        relevance and compliance to best practices.          materials.
                                  supplements, excipients, and     Review complex Reference Standards referred
                                  food ingredients                  from other Expert Committees




P:\03 Council of Experts\CoE 2010-2015\Expert Committees
                           2010-2015 USP Expert Committees and Their Focus Areas, Roles, and Expertise Required
                                                                     Revised January 2010

       Expert Committee                     Focus Areas                    Expert Committee Roles                                Expertise Required
      19. Statistics               General statistics         Develop new and revise existing USP-NF              Expertise in statistics and current industrial
                                   Biostatistics               general chapters requiring extensive statistical     trends of packaging, quality assurance,
                                   Chemometrics                expertise.                                           chemometrics, microbiology, biostatistics,
                                   Epidemiology               Develop and help implement statistical               biological assays (immunochemistry or cell-
                                                                approaches for performance-based                     based assays), epidemiology, manufacturing
                                                                monographs and chapters and for                      and CMC controls.
                                                                demonstration of ―equivalent or better‖ for         Expertise involving the demonstration
                                                                alternative methods.                                 of compliance with FDA current Good
                                                               Serve as a resource to other Expert                  Manufacturing Practices, (identity, strength,
                                                                Committees as required to assure the                 quality and purity).
                                                                appropriate level of statistical rigor is
                                                                maintained.
      20. Toxicology             Food, Dietary Supplements    Develop new and revise existing USP-NF and          Expertise in the role of toxicology as it
                                 Drugs and Excipients          FCC general chapters related to toxicology and       relates to drug development, drug testing
                                 Metals                        product safety testing.                              both pre- and post-market as well as in the
                                 Medical Device               Serve as a resource to other Expert                  role of toxicology as it relates to food
                                  Biocompatibility              Committees and Expert Panels requiring               ingredients and dietary supplements.
                                 Nanotechnology                toxicology guidance                                 Expertise with small molecule and biologics
                                                                                                                     and biotechnology drugs




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