Industry Proposal for Implementation of Single-Use User Requirements (SUUR) Toolkit. Joint BioPhorum / BPSA Team

Transcription

1 Industry Proposal for Implementation of Single-Use User Requirements (SUUR) Toolkit Joint BioPhorum / BPSA Team

2 Introduction Problem Statement implementation of single-use systems in GMP operations frequently expose gaps in expectations between end users and suppliers Proposed Solution equip the industry with common tools to enable clear and consistent communication of user requirements and supplier capabilities in accordance with ASTM E3051 End users Suppliers

3 Three tools have been developed by a joint BioPhorum/BPSA team Single-Use User Requirements Template the template allows end users to communicate process/application details and single use user requirements to suppliers, and allows suppliers to affirm or describe their capabilities to meet these requirements it is organized into a logical structure of user requirement categories, and uses consistent and common terminology Technical Diligence Templates these templates are pre-populated with end-user requests for detailed information that describe how suppliers may fulfil specific user requirements supplier responses to the request for information will allow end users and suppliers to make informed decisions and reduce gaps in understanding between end users and suppliers Supply Chain Template the template is a form that allows end users to communicate requests for supply chain-related information (e.g., component part number and manufacturer) to suppliers, and provides suppliers with a dedicated document to respond to these requests

4 Implementing the SUUR Toolkit has value for both end users and suppliers End User Value Statement increases reliability and robust SUS performance: minimizes non-conformances and regulatory risks caused by gaps in expectations with suppliers speed: reduce timelines for implementing new designs supply chain security and agility: minimizes supply disruptions and facilitates second sourcing through like for like comparison of supplier responses Supplier Value Statement reduces customer complaints: increases understanding of customer application and requirements up front to ensure that designs are fit for use provides consistency in user requirements content and format: reduces resources and time required to respond by preparing standard responses ahead of time reduces frequency of technical visits and increases efficiency of technical visits

5 Introduction to ASTM E3051 ASTM E3051 Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing Section 5. Significance and Use 5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in requirements for sourcing, supply, design, specification, installation, operation, and performance. Proposal is for end users and suppliers to utilize the SUUR toolkit in accordance with ASTM E3051

6 ASTM E3051 Content and Corresponding SUUR Toolkit Elements: User Requirements ASTM E3051 Content Section 7.2 Requirements Definition Quality Requirements - a formal quality agreement, with or without a specifications document, should be provided by end users to suppliers to define overarching requirements and expectations User Requirements - specific requirements should be identified and provide the basis of detailed specification, design, and verification of the SUS The specific requirements relative to product quality and patient safety should be based upon the following: Product knowledge and understanding Process knowledge and understanding Materials knowledge and understanding Supply chain knowledge and understanding Regulatory requirements Company quality requirements Existing Quality Agreements and Audits Corresponding BioPhorum /BPSA SUUR Toolkit Element User Requirements Template Supply Chain Template

7 ASTM E3051 content and corresponding SUUR Toolkit Elements: technical diligence ASTM E3051 Content Section 3 Terminology verification, n - verification is a systematic approach to verify that SUS, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. Section 6.8 Use of Supplier Documentation The supplier s technical capability should be assessed through a technical diligence exercise. Suppliers should demonstrate sufficient technical capability to have control over their design, development and manufacturing processes A technical diligence exercise differs from a quality audit in that it is an open ended exchange of information between SME s at the supplier and end user to provide a shared understanding of expectations and capabilities, rather than confirm compliance with a quality system. Corresponding BioPhorum/ BPSA SUUR Toolkit Element Technical Diligence Template

8 Additional Information For additional information, reference suite of documents: Guideline for use and implementation of SUUR Toolkit FAQ business benefits wheel elevator pitches For any additional questions, contact

9 SUUR Toolkit authors Amgen Inc James Sayer, Takeshi Nishiura Bristol Myers Squibb Roberta Toporovski Catalent Biologics Adriana Freeman, Jon Tiernan Dow Silicones Corporation Csilla Kollar GE Healthcare Jeff Carter, Susan Burke Genentech, a member of the Roche Group Trishna Ray-Chaudhuri Janssen Pharmaceuticals, Inc. William Schaut Meissner Christian Julien Merck & Co. Inc., Kenilworth, NJ, USA Sabrina Restrepo, Danielle Werner Nordson Medical Ken Davis Pall BioPharmaceuticals Kevin Thompson Sanofi Pasteur Jonathan Diel SaniSure Sandra Medlin Sartorius Stedim North America Paul Priebe Shire Plc Mark Maselli Watson-Marlow Fluid Technology Group Sade Mokuolu Biophorum Simon Himsworth

10 SUUR Toolkit contributors Eli Lilly and Company Sarah Langan Entegris Jayanthi Grebin Fujifilm Diosynth Biotechnologies James Dwyer MilliporeSigma Janmeet Anant Saint Gobain Chris Shields Sanofi Pasteur Carl Weitzmann, Charlie Zang

11 Single Use User Requirements acknowledgements NewAge Industries Inc. Alex Kakad Alexion Jason Kennedy Biogen Rob Ballard

12 Disclaimer This template is provided by BioPhorum Operations Group (BioPhorum) and Bio- Process Systems Alliance (BPSA) for the purposes stated herein only. Any inaccuracy or omission in the template by BioPhorum and BPSA is not the responsibility of BioPhorum or BPSA. Determination of whether and/or how to use all or any portion of this template is to be made in your sole and absolute discretion. Prior to using this template, or its contents, you should review it with your own legal counsel. No part of this template constitutes legal advice. Use of this template is voluntary. BioPhorum or BPSA do not make any representations or warranties with respect to this template or its contents. BioPhorum Operations Group Ltd & Bio-Process Systems Alliance, 2018