By Francis Dumont, senior director, drug product supply external strategy, pharmaceutical sciences, Pfizer Inc.
The pharmaceutical industry continues to leverage external supply options for all areas of the business in order to manage costs while assuring continuity of quality supplies and services. The Request for Information/Request for Proposal (RFI/RFP) process to evaluate sourcing partners is a well-established and critical mechanism used to help define these relationships.
There are numerous references to assist with RFI/RFP principles [1-5]. There was even a proposal from academia to generate an industry-aligned, not for profit consortium on RFI/RFP conduct . I also authored two articles on these concepts specific to the clinical drug product manufacturing space several years ago [7, 8].
Applying RFI/RFP principles to technical disciplines with GMP requirements such as clinical supply manufacturing requires due consideration to several areas. These areas range from demand projections through output evaluation of technical and quality competencies. Industry evolution resulting from ever-changing global dynamics, not the least of which includes the Covid-19 crisis, presents a case for streamlining sourcing evaluations to quickly and efficiently select suppliers, or at least narrow the focus of these efforts via an initial RFI. This article offers several considerations for enabling a fit-for-purpose, streamlined approach to the initial RFI stage.
Determine information needed
In the spirit of keeping it simple, it is critical to determine what information is needed immediately to keep a project evaluation progressing versus an exhaustive collection of “nice to have” variables.
Narrowing down the list can be extremely challenging; however, our experience suggests that the following project or process-specific areas offer a good starting point:
• Company locations where blocks of work in scope will be performed • Regulatory status of the supplier in markets of interest • Fit of expertise, equipment and scale to the project(s) being evaluated • Capabilities for testing and releasing products in scope • High level costs (where possible based on confidentiality status and ability to share project details) • Some general, overarching aspects of the supplier can also be considered: o Client audit status regarding the prospective supplier o Financial stability measures o Responsiveness to the request
In my experience, too much time is used for gathering information and too little time and effort are spent on conducting the evaluation in a robust manner. Clearly defining and implementing an evaluation process prior to receipt of responses is key. An example scoring approach that we have successfully used in the clinical-stage, drug product manufacturing space is shown in Table 1.
This table includes scoring definitions that evaluators use when comparing responses. These scoring areas were derived from the refined list of “information needed” in the section above. These data can be readily manipulated to generate graphics that differentiate order of priority for further evaluation and selection.
The example shown in Table 1 uses equal rating across all the categories. However, if a certain attribute is a deal-breaker or critical dimension (e.g. timelines), the weighting of that aspect can be increased or decreased as appropriate. Note also that this format is visually appealing, and outcomes are easy to communicate and comprehend.
Table 1: example scoring method
Determining the appropriate level of quality evaluation at this stage can be challenging for examples such as that highlighted above. Regulatory agencies are continually increasing expectations that sponsor companies fully understand and are accountable for activities conducted at their outsourcing partners [9, 10].
However, overly emphasizing those aspects at the RFI stage may prevent the buyer from evaluating some newly emerging potential partners that could bring significant value to a relationship. Prior to a commitment to actual work, a formal quality-driven audit will provide the opportunity to ruggedly test the quality, regulatory, and compliance aspects of the potential partner, including the identification of any showstoppers. Ongoing quality metrics-based collaboration will also be necessary to maintain awareness and oversight of non-negotiable regulatory expectations.
Making the RFI process as simple, fast and efficient as possible is a desirable outcome for both clients and potential service providers. The motivation for doing so is ever increasing as the pharmaceutical industry responds to evolving expectations and cycle time-driven challenges.
Taking the time to focus on the right questions and developing a clear, systematic approach to reviewing the answers to those questions can help clients (and suppliers) take a meaningful step towards effective, yet streamlined, RFI processes.
I appreciate Paul Stuart’s review and input on this article.
References  https://www.outsourcedpharma.com/doc/simple-steps-to-selecting-the-right-cmo-0001  M. Joyce, “Designing Success into Outsourced Pharmaceutical Projects at the Proposal Stage”, Drug Information Journal, Vol. 36, pp. 67-76, 2002.  S. Chadwick, “The RFI/RFP Process, Opportunities for Those Who are Prepared”, IPA Bulletin, Mar/Apr 2007.  G. Wheaton, (2008) “Request for Proposal” online at Epiqtech.com.  B. Anderson, “The RFP Template: A Template for Writing an RFP to Select a CRO”, Integrative Consulting Services, 2008.  A. Carter et al, “Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)”, BioProcess International, October 15, 2018.  F. Dumont, “Establishing a Vendor Network for Clinical Supply Manufacturing Services”, Pharmaceutical Outsourcing, Vol. 12, Issue 5, pp. 22-28, Sep/Oct 2011.  Dumont, F. and Onorato, S., “Establishing and Managing a Vendor Network for Clinical Supply Manufacturing Services”, Pharmaceutical Engineering, Vol. 33, No. 3, May/June 2013.  B. Ortiz et al, “Increased FDA Scrutiny of Purchasing/Supplier Controls”, Contract Pharma, Vol. 12, Number 8, pp. 100-103, October 2010.  QA Pharm, “Contract Manufacturing Operations and You- The You Part”, Manufacturing & Capabilities Newsletter, October 25, 2010.