USP Organization and Governance
USP’s governing, standards-setting, and management bodies include the USP Convention, the board of trustees, the Council of Experts and its Expert Committees, and staff. Additional volunteer bodies include stakeholder forums, project teams, and quality communication groups, which act in an advisory capacity to provide stakeholder input to USP.
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The USP revision process is based on public participation, FDA’s Observer Program, and participation of manufacturers and professionals.
The General Notices and Requirements section contains the subsection Preservation, Packaging, Storage, and Labeling. Within this subsection are the following pertinent topics:
- Containers—definitions and descriptive information about containers, tamper-evident packaging, light-resistant containers, well-closed containers, tight containers, hermetic containers, single-unit containers, single-dose containers, unit-dose containers, unit-of-use containers, multiple-unit containers, and multiple-dose containers.
- Poison Prevention Packaging Act (PPPA)—references to the PPPA and general information about requirements stated in the PPPA.
- Storage Temperature and Humidity—definitions and descriptive information about freezer, cold, cool, controlled cold temperatures; room temperature; controlled room temperature; warm; excessive heat; protection from freezing; dry place; and storage under nonspecific conditions.
- Guidelines for Packaging and Storage Statements in USP—NF Monographs—general information about providing users of the USP—NF with proper guidance on how to package and store compendial articles.
The Chart Guide section of the USP contains a series of charts that provide an excellent guide to users of the USP—NF for quickly selecting chapters of the USP that pertain to their discipline. Chart 9, Drug Product Distribution, is pertinent to the packaging discipline and is arranged as a flow diagram that describes standards that are applicable to the pathway of a drug product from the manufacturer to the patient. The General Chapters provided in Chart 9 are listed below, including additions and changes that will be prompted by Supplement 2.
General Chapters provided in Chart 9 (Additions and changes in Supplement 2 USP 30/NF25 are noted in brackets):
<87> Biological Reactivity Tests, In Vitro
<88> Biological Reactivity Tests, In Vivo
<381> Elastomeric Closures for Injections
[<660> Containers[ — Glass]
<661> Containers[— Plastics]
<671> Containers—[Performance Testing]
[<681> Repackaging into Single-Unit Containers and Unit-Dose Containers for Nonsterile Solid and Liquid Dosage Forms]
<698> Deliverable Volume
<755> Minimum Fill
<1079> Good Storage and Shipping Practices
<1118> Monitoring Devices—Time, Temperature, and Humidity
<1150> Pharmaceutical Stability
<1146> Packaging Practices—Repackaging a Single Solid Oral Drug Product into a Unit-Dose Container
<1151> Pharmaceutical Dosage Forms
<1177> Good Packaging Practices
<1178> Good Repackaging Practices
<1191> Stability Considerations in Dispensing Practice
<1265> Written Prescription Drug Information-Guidelines
In addition to those listed in Chart 9, there are two other General Chapters pertinent to packaging. They are:
General Requirements: <691> Cotton
General Information: <1207> Sterile Product Packaging—Integrity Evaluation