The West Blog

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Focus on extractables and leachables (E&L) from packaging and delivery systems began in the mid-1990s but, since then, regulatory agencies have become more educated, and expectations of the pharmaceutical industry have increased. Examples of updated recommendations include USP<1663> and <1664> and injectable drug recommendations from Product Quality Research Institute (PQRI). Complex drug product formulations have become more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and drug product.

Will Parker

April 23, 2024

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An important element of drug product lifecycle management is anticipating use of delivery systems. When moving from vial systems to pre-filled syringes and autoinjector systems, factors to consider include patient and caregiver needs, drug product requirements, system components, and performance. This article presents performance of West’s 1-3mL and 1mL Long NovaPure® plungers versus legacy plungers for pre-filled syringes in autoinjectors; both plungers are formulation 4023/50 Gray. Performance of the NovaPure® plungers was equivalent to or better than legacy plunger performance in all aspects. Coupled with the enhanced features of NovaPure® plungers, this work indicates they are suitable when best performance is needed.

Amy A. Kim, Le Ho, Tara Haarlander and T. Page McAndrew

April 18, 2024

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On September 7th, 2023, a long-awaited final guidance was issued by the Food and Drug Administration (FDA) - Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. The document is intended to be used in conjunction with other human factors related guidance and available national and international standards, such as AAMI HE75 and IEC 62366. In this latest guidance, the agency provides its view on best practices for conducting human factors activities for combination products either comprised of a device and a drug or a device and biologic.

Lauren Orme

April 11, 2024

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In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, “Quality Systems—Medical Devices—Particular Requirements for the Application of ISO 9001,” to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).

Fred Cowdery

March 28, 2024

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Have you successfully developed a drug product in a prefilled syringe and are now wondering how to get it on the European market?
According to the European Union Regulation (EU) 2017/745 (MDR) Article 1(9), a prefilled syringe (PFS) is identified as “a single integral product which is intended exclusively for use in the given combination, and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable” (1). According to 2017/745 Article 1(9), you must prove that the device part of your combination product complies with the appropriate General Safety and Performance Requirements (GSPRs) laid out in Annex I of MDR. As you can no longer do a self-assessment, you will need to reach out to one of the currently designated 43 Notified Bodies in Europe (2) to do the conformity assessment for you. The results of the assessment are then captured in the Notified Body Opinion (NBOp) which you are required to include in the submission file to EMA or your national competent authority.