Standards-Setting Activities of USP's Council of Experts - Pharmaceutical Technology

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Standards-Setting Activities of USP's Council of Experts
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.

Pharmaceutical Technology
Volume 35, Issue 3, pp. 78-88

The Expert Committee is establishing an Expert Panel to create Quality Attributes of Therapeutic Monoclonal Antibodies <129> to apply these principles to this biologic product class. In the area of low molecular weight hepa-rins, the existing USP Expert Panel is working on chapters for Anti-Factor IIa and Anti-Factor Xa Assays for Low Molecular Weight Heparins <208> and Low Molecular Weight Heparin Molecular Weight Determinations <209>, which are class-specific procedural general chapters that will establish consistency in how low molecular weight heparin products are analyzed in terms of potency and molecular-weight distribution, two critical product attributes. Other activities will focus on the review and updating of key information chapters, such as Biologics <1041> and Biotechnology-derived Articles <1045>.

Dosage Forms Expert Committee. The General Chapters-Dosage Forms Expert Committee initiates and develops general chapters that provide standards for dosage form performance, physical characterization, default conditions, and development. For dosage form performance, this Expert Committee is developing product quality and product performance chapters for drug products associated with each of the five routes of administration (i.e., oral, skin [topical and transdermal], aerosol, mucosal, and parenteral). The initial step is finalizing the topical and transdermal product quality general chapter <3> and its corresponding product performance chapters <724> and <1724>, followed by similar efforts for the other routes of administration. The Expert Committee is also working on general chapters that describe the product quality and performance characteristics of soft gelatin capsules and is beginning work via an Expert Panel on solubility criteria for veterinary drugs.

Microbiology Expert Committee. The General Chapters-Microbiology Expert Committee develops public documentary standards and allied reference materials that help ensure, where needed, sterility and related quality attributes of medicines. The Expert Committee will develop and update chapters relevant to achieving microbiologically safe articles such as sterile and nonsterile manufactured ingredients and dosage forms. This Expert Committee also is responsible for biological indicators used in the evaluation of sterilization processes. Key initiatives for this committee include development or updating of:

  • Microbiological Control and Monitoring of Aseptic Process Environments <1116>
  • Microbial Characterization, Identification, and Strain Typing <1113>
  • Alternative Microbiological Sampling Methods for Non-sterile Inhaled and Intranasal Products <610>
  • Sterilization and Sterility Assurance of Compendial Articles <1211>
  • Contamination Control in Environments Used in Non-sterile Product Manufacturing (chapter number not yet assigned)
  • Validation of Alternative Microbiological Methods <1223>
  • Modernization of general chapter Sterile Product PackagingIntegrity Evaluation <1207> in concert with General Chapters—Packaging, Storage, and Distribution Expert Committee.

In addition, the Expert Committee will contribute to the further development of AntibioticsMicrobial Assays <81>, along with the development of a workshop on rapid microbiological methods to help set USP's direction in this area.

The Expert Committee also provides microbiology support for committees dealing with food ingredients (FCC), dietary supplements, and excipient issues.

Packaging, Storage, and Distribution Expert Committee. The General Chapters—Packaging, Storage, and Distribution Expert Committee develops and updates USP standards for container-closure systems (i.e., glass, plastic, and elas-tomeric materials). General chapters developed by this Expert Committee define product storage conditions and requirements and provide guidance for good packaging and repackaging practices. In addition, the Expert Committee develops chapters providing guidance for issues related to pharmaceutical supply chain and product distribution. Current key initiatives for this committee are:

  • Modernization of core packaging chapters ContainersGlass <660>, ContainersPlastics <661>, and ContainersPerformance Testing <671>
  • In concert with the General Chapters—Microbiology Expert Committee, modernization of general chapter Sterile Product PackagingIntegrity Evaluation <1207>, which will include guidance on physical integrity evaluation
  • In collaboration with the Toxicology Expert Committee, develop a guidance chapter on extractables and leachables testing for process materials and container-closure system components
  • Finalize new general chapter Packaging Components and Requirements <659>.


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