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The following slides are intended to be used as a general guide to understanding the overall content and purpose of the United States
Pharmacopeial Convention (USP) General Chapter 1079 for the Storage and Shipping of Drug Products.
Contact: Jeff James
https://www.linkedin.com/in/jeffjamessolutions
Al l the s l ides and in format ion prov ided here in are prov ided fo r the purposes of educat ing the publ i c . Presentat ions are in tended fo r educat iona l purposes only and do not rep lace independent , profess iona l judgment . Statements of fact and op in ions expressed are those of the author and, unless express ly stated to the contrary , are not the op in ion or pos i t ion of the USP or i t s committees .
• Defining USP 36:• FDA Guidance vs. Regulation
• Some Definitions
• Scope
• Responsibilities / Labeling
• QMS and GDP’s
• Distribution Management System
• Validation and PQ
• USP 36 in the news…
USP 36 – <1079> Good Storage and Shipping Practices
The Federal Food, Drug and Cosmetic Act Establishes legal framework within which FDA operates.FDA issues regulations through a “notice and comment rulemaking" that allows for public input on a proposed regulation before FDA issues a final regulation.The FDA follows the procedures required by its own "Good Guidance Practice" regulation to issue FDA guidance.FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA.
FDA Guidance vs. Regulation
Distribution: Refers to elements such as shipping and transportation activities that are associated with the movement and supply of drug products.
Drug products: Medicines, including marketed and veterinary prescription finished dosage medications, in‐process/intermediate/bulk materials, drug product samples, clinical trial materials, over‐the‐counter products (OTC).
Supply chain: The continuum of entities spanning the storage and distribution lifecycle of a product to the end user.
Some Definitions
Good storage and distribution practices apply to all organizations and individuals involved in any aspect of the storage and distribution of all drug products…• Manufacturers (and contract manufacturers)• Packaging/repackaging operations• Laboratory operations• Physician and veterinary offices• Pharmacies• Wholesale distributors• Third‐party logistics providers• Mail distributors including the U.S. Postal Service (USPS) and other shipping services including expedited shipping services
Scope
The holder of the drug product application, the drug manufacturer and the repackager responsibility:
• Communicating storage and distribution practice through the supply chain.
• Distribution conditions and excursions that may be allowable.
Product labels should clearly define the storage temperature range.
• Drug products can be transported at temperatures outside of their labeled storage temperatures if stability data and relevant scientific justification demonstrate that product quality is maintained.
Responsibilities & Labeling
Good storage and distribution practices require that entities involved in the storage and/or distribution of drug products maintain a Quality Management System (QMS) that is based on standard quality concepts and cGMPs.
QMS includes the following management system programs:•Storage Management System•Distribution Management System•Environmental Management System•Risk Management System
Quality Management Systems
The storage and distribution QMS should, at minimum, cover the following elements:•corrective and preventive actions (CAPA)•change management•deviation/investigation management•the management review process
QMS “shoulds”
Good Documentation Practices should be followed•Procedures should include “how products are handled when… there are delays in distribution..”
•Deviations should be documented, investigation performed and CAPA assigned.
•Quality Management personnel should reject or approve investigation
•Required documentation should be described in the QMS• i.e. C of A, traceability back to raw bead?
QMS “shoulds” (cont.)
• Distribution of drug products occurs as point‐to‐point movement within the supply chain between distribution facilities via semitrailer trucks, vans, emergency medical service vehicles, industry representatives’ automobiles, trains, aircraft, sea vessels, and mail delivery vehicles.
• Package performance testing should be documented as part of a manufacturer’s QMS. (ISTA and ASTM)
• Packaging for the distribution control, and requirements for each drug product should be selected and tested to ensure that product quality is maintained and to protect the contents from the rigors of distribution including environmental or physical damage.
Distribution Management System
• The container used for transporting the drug product should be qualified on the basis of the labeled conditions of the product as well as anticipated environmental conditions.
• Consideration should be made for seasonal temperature differences, transportation between hemispheres, and the routes and modes of transport.
• The type, size, location, and amount of the temperature stabilizers required to protect the product should be based on documented studies of specific distribution environments.
• Transportation container materials such as warm/cold packs and materials used to control temperature conditions should be properly conditioned before use.
Distribution Management System (cont.)
• Transport Systems should be:• Continuously Monitored, OR• Qualified based on historical data (i.e. ambient profile), OR• NOT monitored OR qualified based on stability data
• Operational and Performance Shipping Studies• Controlled Environment or Field Study
• Studies should reflect:• Actual payloads• Conditions• Extremes
Validation and PQ
“Notice: The Medicines Compendium Web site was discontinued on March 31, 2015. USP plans to develop needed standards for medicines used globally through a new collaborative program that will be announced in the near future.”Source: http://www.usp.org/global/medicines‐compendium
More recently (October 2015):
“USP is reducing its involvement in distribution practices per se. The Expert Committee will continue work on materials of construction for packaging (presumably including the tertiary packaging which constitutes temperature‐controlled shipping), and it will continue to develop at least one part of <1083> pertaining to quality systems in distribution management. But subchapters on other topics may be reduced or eliminated.”Source: Back to the drawing board for USP <1083>, Good Distribution Practices
USP 36 in the news…