Are Suppliers and Contract Organizations Putting Your Product’s Quality at Risk?

Life sciences companies are undergoing a massive transformation from vertically integrated to outsourced and externalized global models. Unfortunately, many companies are finding it difficult to manage quality and compliance activities in an increasingly fragmented ecosystem. While operational models have changed, traditional quality systems and technology infrastructures have not evolved to support this new reality.

This challenge is at the top of regulators’ agenda. While life science companies continue to outsource development, manufacturing, and testing activities, they can not outsource responsibility for quality. According to the International Council for Harmonisation (ICH), “The pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials.”ⁱ This perspective is reaffirmed by regulatory agencies and government regulations. In the EU, EudraLex states that the “The contract giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities.”ⁱⁱ And in the U.S., FDA regards contract facilities “as an extension of the manufacturer’s own facility”ⁱⁱⁱ and therefore expect a company’s supplier network to perform as an extension of their own quality system. Furthermore, FDA holds “the owner’s quality unit ultimately responsible for approving and rejecting drug product manufactured by the contract manufacturer.”^iv

Is your company outsourcing functions such as manufacturing, processing, packing, holding, or testing of your product? If the answer is “Yes”, your suppliers and contract organizations could be putting your product’s quality and your company’s reputation at risk.

To exercise appropriate control over outsourced activities and minimize risk, quality systems and technology infrastructures must be updated to support collaboration and visibility among partners across the ecosystem. Life sciences organizations must shift their focus from internally facing point solutions to web-based platforms designed to give appropriate people access to the right information every time, from everywhere. This level of transparency offers a “single source of truth” for all parties — leading to improved control and collaboration as well as simplifying complex and error prone document exchange processes.

Innovative regulatory and business trends are also driving the need to support a “single source of truth.” Industry leaders and regulators are collaborating to develop risk-based inspectional approaches, supporting “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”^v This collaboration is driving initiatives aimed at incentivizing the industry to focus on improving product quality and moving beyond simply complying with regulatory requirements. Initiatives such as Case for Quality, Quality Metrics and Remote Audits (e-Inspections), and key provisions in FDASIA and EudraLex, further drive the need to achieve improved visibility, and control and collaboration among internal and external partners.

While many life sciences companies are still looking for ways to improve visibility and transparency across their global and outsourced ecosystem — innovative companies are improving supplier visibility, control, and collaboration through cloud-based solutions.

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ⁱ http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline
ⁱⁱ Eudralex Volume 4 Chapter 7, Outsourced Activities
ⁱⁱⁱ 21 CFR 200.10
^iv http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm353925
^vhttp://www.fda.gov/downloads/regulatoryinformation/legislation/significantamendmentstothefdcact/fdasia/ucm363523