Pharmaceutical Technology Europe - September 2010 - (Page 8)

How responsible should the sponsor be for the outsourcing provider’s success? Understanding the cGMP compliance of outsourcing providers is incredibly important. When it comes to the audit process, I believe it completely depends on each individual case as to whether the sponsor should be expected to be involved in the process or not. There are a number of ways that a sponsor can help its outsourcing partner to pass its regulatory audits but first, the sponsor needs to clarify the outsourcing partner’s audit ability using an independent auditor. A regulatory responsibility matrix that clarifies who — the sponsor or the outsourced provider — is responsible for what specific section of the regulation must also be defined. Next, the sponsor may want to work with the outsourced provider to assemble a standing “audit package” that can be given to any regulatory health agency inspector. Finally, the sponsor should consider hiring an independent third-party to conduct a sort of “bulletproof yourself against inspections” type of corporate workshop, which shows the outsourced provider what the inspector looks for. Furthermore, all firms should be cognizant of the recent recommendation that the FDA is considering, that warning letters and other regulatory enforcement actions against a CMO or CRO also be applied to the sponsor. So what happens when problems are identified by the sponsor during the course of the agreement? In general, the sponsor should expect to perform some level of help. Here’s how I suggest my clients set about determining the level of help they will provide, or at least offer: • If the deficiencies found deal specifically with the actual production process for John Avalla net the sponsor’s product rather than just more general CMO processes, then the sponsor needs to offer as much help as possible. • If the deficiencies are more systematic and affect all of the clients of the outsourced provider, the sponsor should be more cautious about direct involvement. At this point, the focus needs to switch back to the sponsor and to find out what other controls the sponsor has in place that mitigate the risks posed by the outsourced provider’s deficiencies. • Finally, if the sponsor’s personnel recognise that the outsourced provider could use some guidance on how to go about resolving any deficiencies, the sponsor should not be shy about suggesting helpful internet sites, published articles, recorded compliance seminars or even independent outside experts for the outsourced provider to consider. PTE Based on a contribution by John Avellanet, Managing Director and Principal of Cerulean Associates LLC. To read the full version of this article, go to www.pharmtech.com/avellanet www.ceruleanllc.com 1 CONTENTS 9 THE RIGHT ASIAN PARTNER 3 SLOW CLIMB BACK 10 INDIAN PERSPECTIVE 6 FINANCIAL CRISIS 14 SUCCESSFUL RELATIONSHIPS 7 HOW TO COMPETE 16 READ MORE… http://www.pharmtech.com/avellanet http://www.ceruleanllc.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - September 2010

Parmaceutical Technology Europe: September 2010
Contents
Pharmaceutical Technology Europe Poll
Slow Climb Back
The effect of teh Financial Crisis on Outsourcing
How a CMO Can Compete In An Increasingly Competitive Market
How Responsible Should the Sponsor Be For The Outsourcing Provider's Success?
How to Identify the Right Partner in Asia-Pacific
The Indian Perspective
The Challenges of Outsourcing Early Development
The Benefits of Outsourcing Highly Potent API Manufacture
Managing an Outsourced Biologics Project
Successfully Managing CMO - Client Relationships
Making a CRO Project Run Smoothly

Pharmaceutical Technology Europe - September 2010