Raising the bar: 5 Areas for Improvement within the Pharmaceutical Outsourcing (CDMO model)

Tye Spillum

WIthin the last few years the Pharmaceutical industry has taken a change in direction.  Outsourcing (CDMO - external manufacturing model) has become a normal course of business. 

WIth first hand experience via writing RFPs, audits, due diligence, assessments (risk / benefit & cost / benefit), SWOT models, Quantitative / Qualitative Analysis, CDMO selection, and project execution, I have seen several instances of Outsourcing deficiencies and a failure to meet industry minimum,  / standard requirements.  Examples of the Top 5 points of emphasis are below in sequential order:
 1) Communication / Decision Plan

Having a communication plan in place can provide clarity & facilitate success in any business model.  Action points with benefits & examples are below:
  • To identify contact information
  • Clarify expectations
  • Define roles / responsibilities (including for decisions)
  • Discuss issues / obstacles to progress
  • Resolve problems in real time
  • Being respectful of others time by coming prepared for meetings with resolution to action items & updates
  • Being proactive vs. reactive
  • All parties showing priority & customer service (Voice of the Customer - VOC from Six Sigma)
2) Inadequate due diligence & selection process for CDMOs

The probability of project success can directly correlate to the selection of a good Partner / Service Provider with the correct skill sets, capabilities, capacities, and resources to meet the project goals & objectives. Here are some action points with benefits & examples: 
  • Project, Technical, Quality, & Business due diligence are critical to project success
  • Customers spending the time and effort necessary to understand your service provider, their strengths & weaknesses, their Quality Systems, Quality metrics, quality of the RFP response can foreshadow what to expect downstream when there are development challenges, compressed timelines (project crashing / fast tracking), scope changes, and clarity to expectations / deliverables
  • An initial paper audit is a starting point but not adequate for decision making
  • You must see, touch, and experience the facility, Quality, Operations, Technical competencies/capabilities, and Management team at a minimum to see if there is a fit
  • Ask for references and follow up to determine feedback
  • The intangibles of internal culture ande & attitude can be just as critical to success
  • A summary report of your due diligence assessment (and a quantitative rating) can provide selection criterion & documented evidence to support a Preferred Supplier Program

3) Quality Audit / Written Procedures

When performing a written audit / request for information as well as while onsite for the due diligence... make a point to review specific (and critical) written procedures.  Hearing and/or seeing a list of written procedures does not specify if the content & intent of the procedure is adequate to meet industry minimum / standard requirements.  At a minimum, you should review and comprehend the following (not intended to be an all inclusive list):

  • Non-conformance/investigation/deviation procedure
  • Out of specification (OOS)/lab investigation report (LIR)
  • Corrective action / preventative action (CAPA)
  • Annual product review (APR)
  • Complaints / adverse events
  • Training program
  • Laboratory testing & stability program
  • Printed materials / labeling control
  • Material control / material handling
  • Regulatory audit / internal audit
4) Request for Proposal (RFP)

Utilizing a RFP process can provide structure, process, predictability, and provide detailed information on the project.  Action points with benefits & examples are below:
  • This requirement & responsibility falls to both the customer & the service provider as it is mutually beneficial
  • The RFP document is the basis of communication & dialogue on project planning with your partner. 
  • First impressions are important to both parties.  A poor RFP (just like a poor Project Proposal from a Service Provider) can reduce interest & the probability of a robust partner.
  • The better the content & structure of a RFP the easier the transition & alignment on a final Statement of Work (SOW)
  • Having a robust RFP process will allow for clarity on project scope, milestones, deliverables, and expectations
  • This is a useful tool for project planning and developing a robust SOW
  • The better the planning & communication on the front end of any agreement (specifically in writing) the better the output - enough said
5) Quality Agreements

Quality Agreements are not a plan for failure but a plan for success in how to collaborate on events as they occur. A template must be unique to the project scope, products identified, and service provider systems... this is not a, “one size fits all” scenario and requires attention to detail.  Action points with benefits & examples are below:
  • If you don’t have Quality Agreements in place then make them a priority to establish
  • Definitions and Scope are defined
  • Roles & responsibilities are addressed
  • Conflict resolution procedure is outlined
  • Quality Systems are defined including minimum requirements
  • A Quality communication plan is established
  • Most importantly... minimum regulatory & customer requirements are met
  • Use of a RACI (Responsible, Accountable, Consulted, Informed) Chart as an attachment can be beneficial as well
In summary, providing focus to the Top 5 points of emphasis above in addition to  incorporation of lessons learned from past projects can position you for success into project execution and provide downstream benefits.