USP Readies Storage and Transport Guidance
Published: March 1st, 2011
The guidance is intended for use by all parties in the supply chain.
After three years of work and extensive input from industry, FDA, and regulatory bodies globally, the United States Pharmacopeia Packaging, Storage, and Distribution Expert Committee (PSD EC) has completed work on USP General Chapter <1079>, Good Storage and Transportation Practices For Drug Products. In a Q&A with PMP News senior editor David Vaczek, Expert Committee chair Mary Foster, PharmD, discusses some of the highlights of the proposed USP Guidance the committee has written. As a working member of the USP’s 21 expert committees, Foster also serves as the Chair of the PSD EC. She is employed as vice president quality at Catalent Pharma Solutions.
Q: What is the status of USP <1079>?
Foster: The final document is due into the USP Pharmacopeia Forum review process at the end of March 2011.
Q: One of the committee’s goals was to harmonize U.S. standards with global requirements. To what extent has that been achieved?
Foster: The 2005–2010 Expert Committee (EC) reached out to six regulatory agencies, and the new 2010–2015 EC has worked extensively with four agencies over the past four months (FDA, MHRA, Health Canada, and German authorities). The EC has listened to the WHO and organizations such as UNICEF to ensure a global strategy is expressed in the chapter. Most importantly, the EC engaged supply-chain businesses, academia, and organizations from around the world to provide feedback and edit sections of this chapter. The intent has been to get it right as a working guidance chapter.
Q: You have said the committee wanted guidance that stakeholders could “pick up and use.” How much direction does USP <1079> provide on specifics?
Foster: The “pick up and use” mindset is the express intent in this revision of <1079>. The chapter is guidance to users and should explain current best practice expectations. The guidance provides examples to more fully explain context but is not a “how-to” workbook. The original revision was close to 60 pages and was just too unwieldy to be a helpful guidance. There are various industry organizations with subject matter experts writing how-to guides detailing their interpretation of regulatory guidance and pharmacopeia chapters.
Q: How does USP <1079> relate to PDA’s Technical Report 39 and Tech 46 guidance?
Foster: The PDA’s Technical Reports (TR) are excellent resources for more in-depth how-to documents. The <1079> references PDA TR as well as other organization documents such as the International Air Transportation Association (IATA) Chapter 17 where appropriate. The <1079> chapter is a USP document that provides general guidance to USP users. It is written in concert with regulatory agency review, academia, and industry input and undergoes a worldwide review through the standard process employed by USP. The comments from this process are each reviewed and edits may or may not occur as a result of this feedback review. USP standards and guidance are recognized worldwide, and I can think of no other standards setting body from the U.S. base that has the same magnitude of use. Regulatory bodies such as FDA have acknowledged the USP as guidance for the pharma/bio industry.
Q: The committee received extensive feedback from industry since it began its work. How, for example, has the guidance focus or content changed?
Foster: The past work was based on a matrix approach to cover movement and storage of product. While this approach was very thorough, the end result was too much material for a general guidance chapter. The final document published last year was very general and the comments reflected the fact that users determined the wording was too restrictive to allow for alternative approaches. One of the major changes has been to write in what I call “however” statements. The chapter describes best practices, but now also expresses the basic fact that there are many ways to attain an acceptable end outcome. The text generally follows these four premises: 1) using a quality systems approach to storage and distribution practices with an emphasis on the risk management system, 2) ensuring transparency and collaboration between all appropriate entities with an emphasis on communication and written agreements, 3) understanding global drug movement, and 4) accountability for any entity holding or transporting product.
Q: USP <1079> does not cover pedigree practices and anticounterfeiting, but USP will be taking up the issue?
Foster: Chapter <1079> does not address pedigree, anticounterfeiting, and supply-chain integrity (SCI). The EC is working on a new chapter to cover this subject. I participated in a recent EU conference and a question was posed as to why the USP had determined the need for a guidance chapter on SCI. The USP EC is very willing to learn from organizations to help decide on the direction of new chapters, but the USP Conference consists of an international contingency with more than 500 members voting on the final working plan for ECs. Decisions for work within the context of the USP are taken with grave consideration to what is current and how the pharmacopeia can best provide continuous improvements to the pharmaceutical and biotechnology world.
Q: Quality service agreements were extensively debated. How are they addressed?
Foster: The final decision on quality service agreements was to define any such agreement between entities as “written agreements” based on feedback from regulators. In fact, one regulatory agency representative was instrumental in writing this section of the chapter.
Q: Does the guidance define standard practices for labeling?
Foster: The <1079> chapter does provide guidance on labeling with an emphasis in two areas: 1) outer container labeling for incoming assessment and 2) storage requirements defined on labeling.
Q: What does the guidance say about using mean kinetic temperature in package testing?
Foster: The past version of <1079> had deleted MKT because this subject was covered elsewhere in the USP. Overwhelming the comments back from industry was to put MKT back in with more information on how to use this calculation. We listened and agreed. This section of the chapter is currently under final revision by one of the primary authors of MKT use in the pharma industry and will explain how to use the calculation in storage and distribution practices.
Q: How will <1079> change manufacturers’ practices with downstream partners?
Foster: Our intent with <1079> is to make it a working chapter used by all appropriate supply-chain entities. The EC is in contact with them and getting their feedback and edits to ensure the chapter is value added to their processes (from airlines to end-users). Have we got it 100% right? Not yet, but we are working to be current and provide the best practice guidance available through the USP chapter process. The EC will revisit the published chapter in about three years or less depending on what changes and becomes current best practice.
Q: In requiring manufacturer accountability for product through to end users, <1079> is sweeping. Is industry ready?
Foster: The EC realizes the scope is broad and has written a general guidance of best practice for continuous improvement among various supply-chain entities. I believe the supply-chain accountability factor is one of the hottest topics in the context of the big picture. The applicant holding entity bears the responsibility and accountability for the drug product in the largest sense today even though this entity may have nothing to do with the final stages of the life cycle prior to administration.
There is still much to be worked out but we all realize that the prime objective is to ensure product identity, strength, quality, purity, and safety is intact throughout the supply chain. The pharmacopeia EC welcomes feedback and edits from industry organizations. This EC does not have all the answers but we are expecting to provide as much guidance as is practical in March 2011.