What is the Best Way to Develop an RFP?

Posted by David Watt

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wellspring-RFP-graphic.pngWhen a pharmaceutical company has a drug product and is in search of a contract manufacturing site to make its product, it usually puts out a request for proposals (RFP) to gather information regarding time, cost and the organization. While this might sound routine, the truth is that a mediocre, poorly organized RFP has the potential to slow the process of selecting the right manufacturer, drive up technology transfer and commercial product costs and also negatively impact the relationship between the sponsor and the manufacturer.

A recent trend in the industry is that drug owners are becoming increasingly more reluctant to provide formulation information. This may be because they’re concerned about the confidentiality of their intellectual property or they don’t feel it’s necessary to provide all of that information upfront. Instead they are only looking for costs associated with moving the product to a new manufacturer and the long-term commercial costs of producing that product. However, even if it’s “just” a coated tablet, a contract manufacturer needs adequate information to provide a credible, complete bid. To this point, a contract manufacturer may need answers to the following questions:

  • What is the formula?
  • What manufacturing processes will be required?
  • Is there specialized equipment required?
  • Can you provide the API safety data?
  • What materials and associated grades or specifications are needed?
  • What size is the bottle and cap?
  • Does it require a desiccant?
  • Does it have cotton, a label and/or an outsert?
  • What Quality Control Testing is required?
  • What is the regulatory strategy?

It all makes a difference because each of those components has a price and a procedure to convert them to a final product.

Under the ICH Q10 guidelines, there are management responsibilities to ensure control and review of outsourced activities. The goal of a technology transfer, as required by the FDA and ICH, is to transfer the product and process knowledge smoothly and seamlessly to achieve product realization. Communication is vital in this process and one of the key methods the FDA recommends is a quality agreement that outlines the roles and responsibilities of each party.

It is also important to consider the environmental health and safety aspects associated with the formulization, either through a material safety data sheet (MSDS) or through categorization by specialists. Many contract manufacturers and sponsors use what we call Safe Bridge Consultants Potent Compounds Safety Rating. Their methodology provides a compound rating based, on four category levels of risk to help minimize exposure of manufacturing employees to potentially dangerous compounds they safely handle on an everyday basis.

If you want to create a better RFP, pay attention to the details that will allow the prospective partner to assess requirements and prepare an accurate quotation. To find this information in your organization, seek input from leaders with relevant knowledge, including those in quality systems, purchasing, health and safety, and planning. The last thing a company should do when seeking a strategic manufacturing partner is to put out a generic, boilerplate RFP that may not adequately address all of your outsourcing needs. A thoughtful, well-reasoned RFP is required to adequately outline the scope of work and to meet the new industry guidelines on technology transfer as required by ICH and most regulatory authorities such as the FDA.

Lastly, in order to get the figures you need to make effective outsourcing decisions, you’ll need to provide the CMO with information in six key areas:

  1. The product formulation
  2. The regulatory strategy
  3. The method of manufacturing
  4. Raw material and packaging components
  5. Analytical test methods and analytical specifications
  6. Twelve-month manufacturing unit forecast

 With a well thought out and detailed RFP, all the manufacturing, process and quality-related factors are communicated between the two parties up-front. The result is almost always a better flow to the project and a better, longer-lasting and more lucrative relationship down the road.

Topics: ICH Q10, CMO, RFP

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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