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

• 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)

• 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

• 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

• 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
   

You Should Check Out:

Career Spotlight: Pharma Regulatory Affairs

Global Clinical Outsourcing Forum – Avoids Death by PowerPoint with New Format – Round Up

Targeting New Markets to Improve Pharma Sales Force Effectiveness