Collaborating with a Service Provider
Posted on Wed, Jan 25, 2012
There are times when a white paper comes across our desk that we wish we wrote it. That's the case with a white paper from DPT Laboratories, a contract development and manufacturing organization.
DPT Laboratories white paper titled, "Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider" outlines very clearly a strategy for choosing a service provider to ensure high quality service. You can request the white paper from Outsourcing Pharma.com
Choosing a Service Provider
Here are two paragraphs directly from the white paper. Careful choice of a service provider is the essential first step to ensure high quality services. Today sponsors review a service provider’s quality programs as early as the due diligence audit in the selection process. They seek partners who adhere to cGMP regulations and other regulatory requirements and have strong quality management systems.
They also look for service providers who have robust operating procedures, thoroughly research suppliers and inspect raw materials, investigate product quality deviations, and maintain reliable testing laboratories. The provider should have and follow current rigorous standard operating procedures (SOPs) and best practices.
In addition to looking at basic qualifications, capabilities and costs, pharmaceutical companies should assess the following in their audit:
- Is the provider’s regulatory compliance record stellar,demonstrating its knowledge and understanding of theapproval process?
Getting a project up and running is costly and time consuming. Many organizations face capacity issues that stand in the way of pursuing promising projects. Often, internal resources are already dedicated or can be difficult to identify in support of projects.
Building out infrastructure for projects with significant risk can be hard to justify and isn’t sustainable in a business culture of reduced budgets and downsizing. Recruiting, training and integrating a qualified team can slow forward progress and create ancillary ramp-up and wind down issues. Accessing the required expertise can challenge even the most mature companies.
The day has passed when companies could afford to build excess infrastructure, suffer the time and cost of assembling and, in many cases, disassembling teams, and incur delays in project progress that undermine optimal returns. On the opposite end, the traditional out-sourcing approach relying on tactical task management is not well suited for many of today’s challenging development programs.
