Key questions to ask a contract manufacturer

The COVID-19 pandemic brought new demand to the dietary supplement industry, as more consumers began looking to immune-boosting supplements to help support good health, a Financial Times article noted. At the same time, the pandemic brought disruptions to the global supply chain unlike any seen before.

Companies are trying to build their capacity to keep up with increasing demand, while also navigating operational changes due to safety concerns, such as decreased staff on the manufacturing floor and forgoing on-site audits. Shortages have led to surges, which could open the door to new risks, such as adulterated or subpotent ingredients from new suppliers who may lack quality. One important step in addressing these challenges is verifying new contract manufacturers and ingredient suppliers have the right procedures in place to ensure quality for the products they are developing.

When looking for a quality-driven contract manufacturer, consider several key questions.

1. Is the firm compliant with current good manufacturing practices (cGMPs)?

An important first question to address when bringing on a new contract manufacturer is whether it has the proper systems and technology to meet compliance for a brand’s specific dietary ingredient or product. Each contract manufacturing site must comply with GMPs for six production systems:

• A quality management system assures overall compliance with cGMPs and internal procedures and specifications.

• A facilities and equipment system includes activities that provide an appropriate physical environment and resources used in the production of products.

• A material system includes measures and activities to control raw material ingredients, other components, intermediates, containers and labels.

• A production system includes measures and activities to control the manufacture of products.

• A packaging and labeling system includes measures and activities that control the packaging and labeling of products.  

• A laboratory control system includes measures and activities related to testing raw materials and finished product for conformance to specifications.

2. Will the contract manufacturer accommodate a facility audit?

A company should audit new contract manufacturers for initial qualification to its specific dietary ingredient or product needs. For example, a contract manufacturer may document that it can produce liquid dietary supplements, but during the facility audit, a liquid line is not on the site.

To read this article in its entirety, check out the Insight into contract manufacturing – digital magazine.

Ed Wyszumiala is the director of market development for the verification programs at U.S. Pharmacopeia (USP).