In a volatile and highly competitive market, one way for pharma companies to keep an edge is through better communication. Companies routinely outsource the services and processes involved in the formulation, manufacture, packaging, labeling, and delivery of products. Leveraging the resources of third parties can be both cost-effective and efficient. But not all companies successfully communicate and collaborate with their partners to capitalize on those benefits.
Many factors contribute to that missed opportunity, including
This article outlines the steps that pharma companies can take to improve such communication and thus ensure a more timely supply of data and material, speed the product's time to market, improve return on investment, and maximize the full benefits of outsourcing.
Ensure Compliance As new suppliers enter the marketplace, pharma organizations must ensure that their trading partners are in compliance with FDA regulations and must require documentary evidence, such as consultant r貵m豬 that verify the third party's ability to do the job. Some companies have taken the lead and initiated stringent supplier qualification protocols. Others are informally taking the concepts of 21 CFR Part 820 (Quality Systems), which are primarily applicable to the device, diagnostics, and biologics industries, and applying them to drug development audits.
Because FDA cannot directly regulate industry suppliers, pharma companies bear full responsibility for verifying that their trading partners meet best practices and standards for good manufacturing, have validated systems and processes, and employ trained and experienced staff. Many companies currently perform thorough vendor audits for raw materials suppliers and software providers, but few adequately check the compliance levels of other third parties, including contract manufacturers, transportation agents, and consultants. But with new suppliers moving into the marketplace from less-regulated industries, pharma companies need to be especially vigilant in establishing that their trading partners possess the necessary credentials to meet FDA standards.
The failure to ensure third-party compliance could have severe consequences. For example, if a pre-approval audit of a clinical trial determines that a contractor lacks the experience needed to perform the work, FDA could void the study. To mitigate such large expenditures-and possible fines-companies should develop formal policies specifying third-party compliance levels, communicate those policies, and follow up with audit and oversight, including the identification of deficiencies and actions needed to correct them.
Enhance Change Control Collaborative product commerce software-such as offerings from PTC and MatrixOne-use internet technology to open up lines of communication between pharma companies and their suppliers. Those software tools can enable various groups to work together more productively to achieve reliable, FDA-compliant changes in product specifications.
Making informed, change-control decisions requires convenient access to all data collected during the development process. Yet, the data often reside in lab notebooks and other forms of internal documentation that omit critical information, such as input from workers involved only at the beginning or end of a given process. Collaborative product commerce solutions help organizations efficiently capture all of the needed information, including the complete audit trail showing who was involved in making critical decisions and what issues were discussed during development.
With the ability to perform reverse engineering, even for decisions made years before, pharma companies can respond to FDA reviews more quickly than they could with only paper documentation. In addition, companies can use those applications to view the overall drug development process and identify opportunities for efficiency improvements and cost reductions.
The value of electronic access to critical documentation is illustrated in the following example. Employees involved in critical processes are issued lab notebooks in which they record important data. The notebooks are numbered, reviewed, and approved by supervisors, then archived when full. Once the notebooks are archived, key data are virtually buried.
One biotech company experienced a problem during scale-up of an active ingredient for a clinical trial. It eventually discovered a solution after three months of unearthing and analyzing more than 50 lab notebooks. Meanwhile, product development and the start of the trial were on hold. If the data buried in the notebooks had been available online, the company could have found its solution in about a week.
Transfer Knowledge Efficiently Pharma companies often pay third-party vendors millions of dollars for their expertise, and they should be able to take away at least some of that knowledge after the project is completed. By overseeing the manufacturing and testing methods that the vendor uses, pharma companies can share, receive, and use that knowledge efficiently. A best-in-class strategy allows for timely electronic capture of data to improve compliance while providing a method for technology transfer when launch is imminent and scale-up to commercial quantities is required. Pharma companies should contract with vendors to have part of their payment contingent upon the successful transfer of a predetermined level of information.