EDITOR'S NOTE: This is Part 1 of a two-part blog series about vendor selection. Read Part 2 here.
In a good practice (GxP) regulated world, our hands are full creating processes that are controlled, verifiable and traceable. But for all the effort we place on functions that impact the quality of a product or service, it is a wonder that vendor selection does not strictly fall under a quality system. But hang on! Standard operating procedures (SOPs) on vendor selection are likely part of any quality system. But in my experience, SOPs focus on the “what” instead of the “how” vendor selection.
A vendor selection SOP for an active pharmaceutical ingredient (API) supplier contract manufacturer or packager should identify the functions responsible for outsourcing, authorization and procurement. But the actual process will center on a well-written request for proposal (RFP) as a key tool for direction and control. If a sponsor does not use its own RFP, it is often because the process is time consuming and can be too easily off-loaded to the Business Development (BD) representative of a visiting contract manufacturing organization (CMO). This hand-off literally robs the sponsor of leverage/control and, therefore, money. If you find yourself tempted to fall into this situation, the following is a process to develop your RFP quickly with the appropriate level of detail.
Begin a conversation with any BD professional by mentioning the first of the following questions and they will probably finish the list for you as a rote exercise:
Each modality should have its own template with customized sections of supporting information. But, at the highest level, every RFP should answer these three questions. The first “easy” question, however, is probably the hardest and requires more than a passing response.
The answer needs to have a detailed and specific response that includes:
1. Product (physical output) - This encompasses the modalities mentioned above. You need to identify the API, then differentiate immediately among bulk drug substance or product, packaging, etc. Give additional levels of granularity as needed, e.g., sterile product versus Solid Oral Dose Form (SODF); tablet versus capsule; clinical versus commercial packaging, etc. This information quickly allows a CMO to screen the product against their capabilities to determine a preliminary fit.
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2. Information (data) - In a regulated environment, no product moves without proper documentation and/or identifying information appropriate for its stage of development. It is useful to identify what data you want to accompany the physical or experimental output of the product. For example, early development work may require a development report to select from a range of prototypes. Current Good Manufacturing Practice (CGMP) material may require a certificate of analysis and stability data; clinical packaging may require a study of specific labels and shipping documents, etc. Requesting a Certificate of Analysis (COA) implies that specifications, test methods and analytical support will be needed as part of a scope. From the data request, a CMO will infer what additional services will be required and expect that supporting information will be provided.
3. Use (purpose) - This information will quickly convey to a CMO what quality system environment will be needed for product related work that will impact handling, processing, testing and, ultimately, cost. Early work for formulation selection or tox studies (GLP) is done in a different environment than clinical supplies for human use (CGMP) and carries a very different cost.
Once the initial question is addressed, the next two questions are straightforward … or are they?
Specifying a quantity alerts the CMO as to the scale of your request and is a screen to find out if manufacturing slots are available for appropriately sized equipment, i.e., batch sizes. In the lab, work flow must be managed as well. On a recent project, a client needed multiple metric tons of spray dried material for a Phase III study. This information quickly screened out all but the largest suppliers. While the actual ordered quantities of any project can change, communicating the magnitude is key information for a CMO. As a critical aside, arriving at a total supply needed for clinical supplies is an often-underestimated task. It requires a methodology to convert a given proposed clinical protocol into a supply forecast and production schedule. Likewise, in commercial production, forecasting is often more of an art than a science demanding a disciplined approach to cross-functional planning.
Inherent in the “quantity ask” are delivery dates. For a CMO, this is a sanity check for realistic planning and for setting expectations. Currently, manufacturing slots for biologics or aseptic processing can be 12 months out with stiff cancellation fees. A sponsor that sets a filing date without adequate high-level planning or input from the chemistry manufacturing and controls (CMC) organization and the supply chain team may develop unrealistic expectations. A delivery date of drug product six-month stability data on three registration batches for an inbound product inside of 18 months from receipt of the RFP is highly aggressive for a SODF, nearly impossible for a sterile product, and out of the question for a biologic. Working through the timing of dependent activities is not only important for the CMO, but for a sponsor as well.
With an RFP defined, the body of the document should now focus on company background, legal and administrative notices, supporting information, deliverables and milestone dates. Of these, the supporting information is the most important to the CMO. Your supporting information should be focused on the modality of the ask. So, if your product is a tablet, provide a batch record. If you want released product and stability, provide specifications and a stability protocol. Below is a starting list of information you need to provide. Depending on the modality and use, subsets of supporting documents would be required.
Table of Contents for Small Molecule Commercial Tech Transfer Example:
1. Executive Summary
2. Company Background
3. Supporting Information
a. API Structure, Chemistry, Specififications, Storage Handling
b. Drug Product: Formulation, Process, Specifications, Storage and Handling
c. Packaging: Components, Specifications, Labels/Labeling Information
d. Analytical Test Methods: API, DP, Cleaning, other
5. Project Scope
8. Key Milestones
9. Legal and Administration: Submission of proposals, legal notices, contacts
b. Batch Record
c. Packaging Record
d. Stability Protocol
The various sections serve to provide a nearly complete profile of product information to support the ask that is adequate for CMOs to return comparable reports. This should seed technical discussions that will help you with your selection process and contract negotiations. In Part 2 of this two-post blog series, I will discuss what to expect in vendor proposals and how to effectively compare them to find the best fit for your project.
Ray Sison started consulting in 2011 after recognizing a need for expertise in pharmaceutical outsourcing among the discovery and clinical stage pharma companies he served while selling services at Patheon and MDS Pharma Services. From his CMO experience, Sison provides insight to their business and operations so his clients can negotiate and achieve better outcomes. Additionally, he has developed sound processes and templates to streamline CMO procurement to save time and cost. In this series of articles as well as online webinars, Sison continues to build content to share best practices and case studies helping improve the outsourced business model.