While using third-party contract manufacturers has become a common trend in the pharmaceutical and biotech industry, it is not without contract manufacturing risks. The practice supposedly keeps costs down by avoiding equipment, validation, personnel, and other production expenses, leaving the burden of following Good Manufacturing Practices (GMPs) on the contract manufacturer, but this may not always be the case. While utilizing a contract manufacturer is a strategic move in terms of avoiding obvious costs, the downside is the loss of direct control over the quality and consistency of products bearing the brand and representing the reputation of the sponsor selling those products. Not having control over the culture and processes involved incurs hidden costs.
Justin Prochnow, a principal of the Greenberg Traurig legal firm, emphasizes the need for companies to have a rock-solid and detailed quality agreement with their contract manufacturer. The FDA has made it clear: if your name is on the bottle, the responsibility is yours, and companies feign ignorance of regulations.
Prochnow reiterates that brands should have procedures in place to verify the quality of Finished Goods that were outsourced before they enter the marketplace. For many small companies, having the staff to test shipments may not make sense. It doesn’t matter if a third-party quality control firm handles it, only that there are procedures in place to reduce contract manufacturing risks.
Companies often don’t realize as a holder and/or distributors of products; they are the final safeguard in place before a product becomes available to the public. They are the last line of defense to spot adulterated or contaminated batches and the first target of the FDA during a recall.
If you’re a holder or distributor or use a contract manufacturer to handle your manufacturing, be sure to take a look at our quality solutions. We offer specific holding and distribution Standard Operating Procedures and affordable cloud-based cGMP compliance software, InstantGMP™ PRO. Be sure to sign up for a live demo, and our team will show you how you can streamline the quality process.