Posted 13 January 2016
[Editor's note: RAPS will be hosting an eCTD workshop 13-14 April. More details here.]
Regulatory Focus Interviews Steve LoCastro and Sharen Johnson, West Pharmaceutical Services
For pharmaceutical companies, filing Common Technical Documents (CTDs) is a critical aspect to the regulatory approval process. Historically, this process has been paper-centric until recently. This exclusive interview features a recent collaborative effort between West Pharmaceutical Services, FDA, Health Canada and others to establish a process and protocol for filing CTDs electronically, which will likely become common practice as early as 2017.
RF—In May 2015, the US FDA published the guidance "Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications." Among other things, it sets a deadline of 15 May 2017 for submissions like Drug Master Files (DMFs) to be transitioned to eCTD format. Why is this important for pharmaceutical manufacturers?
WPS—Until now, the industry's move to eCTD has focused on marketing applications and clinical trial applications. With this new guidance, eCTD will be mandated by FDA for supplier DMFs supporting these applications.
While eCTD requirements have been in place for many years, they were not designed to accommodate suppliers' offerings, like closure components. This has created a disconnect with drug marketing applications being filed to FDA electronically, but still referencing paper DMFs for important supporting information.
Continued reliance on paper DMFs requires FDA reviewers to resort to a slower and less automated process to obtain needed reference information during application reviews. This situation clearly needed improvement and West took on the challenge of addressing it from several perspectives, including processes and resources.
West was proud to work with FDA to develop a strategic plan for electronic Type III and V DMFs. We feel our experience provides a strong case study on how to collaboratively bring a new process together and foster an ongoing dialogue with FDA.
RF—How did West approach this project?
WPS—West maintains an extensive DMF portfolio with FDA and Health Canada for our products and processes. We issue more than 1,500 Letters of Authorization (LOA) to our customers annually. Our elastomer formulations DMF is one of the most heavily accessed master files held by FDA. Given this, FDA was very amenable to seeing our DMFs transition to eCTD, and had discussed the possibility with us on several occasions. We initially developed a strategy document detailing necessary steps, required deliverables and critical interdependencies.
West evaluated existing in-house document management platforms as well as external electronic publishing options and identified additional software required to establish a robust electronic submission management system.
For document authoring and management, we assessed an existing platform to determine whether it could be sufficiently customized to support our requirements, including: versioning and document approval for traceability; meeting agency PDF document security specifications; and maintenance of document integrity.
We evaluated three basic options for our electronic publishing needs: software purchase, Software-as-a-Service (SaaS) and outsourcing. Each option was evaluated against our estimated submission workload to compare cost effectiveness.
Finally, without a recommended conversion approach available for our files, we decided to engage both FDA and Health Canada in a collaborative effort to define best practices moving forward.
RF—What role did collaborating with FDA play in developing standards for eCTD DMFs?
WPS—There was a unique opportunity to build and refine DMF submission requirements and West's position as an industry leader in pharmaceutical packaging components allowed the company to work collaboratively with FDA on this initiative. It also was in the mutual interest of West, FDA and our customers to work together to optimize our own submission process.
Through collaborative discussions, West and FDA identified and addressed challenges in the former process, as well as challenges specific to managing eCTD DMFs in the process moving forward.
For example, LOAs have always been processed in paper at FDA and managed separately from the DMFs. However, with the move to eCTD, both West and FDA will manage LOAs electronically as part of each DMF. This change required a new process for managing these important documents.
To that end, we not only eagerly participated in the FDA pilot, but are now similarly collaborating with Health Canada on their supplier DMFs.
RF—What challenges do suppliers like West face in converting their DMFs into eCTD documents?
WPS—Previously, there were not electronic file requirements for supplier items like packaging submissions. International Council for Harmonisation requirements for eCTD submissions were designed for drug applications, and supplier components and processes do not neatly fit into these requirements. The biggest challenge was adapting these requirements to our file types.
Another challenge for suppliers is their own regulatory infrastructure and how submission documents will be processed and archived.
Finally, suppliers need to choose an electronic publishing option to meet their needs. West selected a SaaS option as an optimum choice between cost and functionality. Fortunately, we found a vendor who has built flexibility into our partnership and is able to accommodate West's specifications.
We feel that we found a solution that works for everyone—the Agency, our IT department and the West regulatory team.
RF—What progress has West made to date?
WPS—West has submitted five DMFs in eCTD—four conversions and one new submission with others on the way. Each DMF subject may be submitted with CDER, CBER, CDRH and Health Canada. We expect to have our entire portfolio converted by the end of 2016.
We have learned from one of our key customers that by utilizing eCTD for the DMF, there has already been a direct benefit to their overall submission process, including a simplified, streamlined review experience. Certainly, an important way to measure our success is knowing our improved processes are making it simpler to do business with West.
West also has been collaborating for the better part of a year with our manufacturing partner Daikyo Seiko to assist them in navigating the transition process to eCTD, and several of their DMFs have been converted as well.
About West Pharmaceutical Services
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. For more information, please visit West online at www.westpharma.com.
About the Interview Candidates
Steve LoCastro is Director of Regulatory Affairs at West Pharmaceutical Services in Exton, PA. He has been a CMC regulatory affairs professional for the past 17 years with a wide range of experience in regulatory submissions for both small molecules and biopharmaceuticals. Prior to joining West, he worked for GlaxoSmithKline and Vicuron Pharmaceuticals. He received a BS in chemistry from Drexel University and an MS in organic chemistry from Villanova University.
Sharen Johnson is senior submission specialist at West Pharmaceutical Services. She has been in the pharmaceutical industry for more than 25 years and a regulatory affairs professional experienced in a wide range of regulatory submissions for the last 16 years. Prior to joining West, she was employed by GlaxoSmithKline for 20 years. She has a BS in Information Technology from Pierce College.