Active pharmaceutical ingredients (APIs), excipients, dietary supplements, medical devices, combination products, reagents, solvents, biological, and cell and gene therapy are among topics now included in USP’s General Chapters on Good Distribution Practices (GDPs).
These topics, included for the first time, were described in the presentation, “Update on Subjects Becoming Next Sub-Chapters Plus an Overview of Extractables & Leachables from the Transportation Perspective,” by Mary Foster, USP Expert Committee Chair, and consultant with The Foster Group, LLC. Foster spoke at the 12th Annual Cold Chain GDP & Temperature Management Logistics Global Forum, held Sept. 29 to Oct. 3, 2014 in Boston.
Foster noted that existing General Chapter <1079> on Good Storage and Shipping Practices is aging and that <1083> provides more current, updated information. To be determined is if GDP Sub-Chapters are needed for Clinical Trials Materials, specifically in the following areas:
• Standard Operating Procedures for blinding
• Labeling
• Risk
• Commercial vs noncommercial clinical trials
• Qualification of packaging
One of the findings brought up by Foster is that biologic products, despite their environmental sensitivities, will be covered within a subchapter on drugs. She said biologics could be given special consideration within the subchapter, noting that USP will seek industry experts in the area of biologics.
Foster noted that there are 24 USP committees that develop and update standards, and are written by experts globally.
In her presentation, Foster noted that there exists a “gig issue in handling adulterated drugs, particularly with APIs. She recommended that when such product adultery is uncovered, it’s critical to notify a regulatory authority, not just your supplier.
Foster noted that UPS seeks to fill in gaps that may exist between existing current Good Manufacturing Practices and Good Distribution Practices. She also made the following points:
• There are significant changes in environmental conditions management, at facilities, within vehicles, equipment, and among the use of packaging materials, such as thermal blankets, temperature stabilizers, light-resistant materials, and desiccants.
• Contigency plans are needed for outages, breakdowns, and short-term excursions , which represent “one of biggest bugaboos industry deals with,” according to Foster.
Foster again sought industry expertise from among the audience in the event to participate and help shape the future of USP documentation. Areas of focus that become effective next year will include clinical trials, finished drug products (and biologics), excipients, APIs, and packaging components and materials.
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