Are your choosing the right raw materials suppliers for your API? Successful commercialization depends on it.


As every Contract Manufacturing Organization (CMO) knows, sourcing raw materials is critical to drug development and can make or break the chances for successful commercialization. Whether the project requires off-the-shelf or customized ingredients, cultivating sound, trustworthy and reliable supplier relationships significantly increases the chances of minimizing impurities and meeting project timelines.

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Supplier qualification refers to the overall quality management of outsourced materials and activities as they relate to drug product and API manufacturing. It also is part of a regulated Pharmaceutical Quality System that is required according to Current Good Manufacturing Practices (cGMP), and ensures the consistent quality and safety of raw materials.

Supplier qualification is not only a requirement of cGMP, but it’s also mandated by the U.S. FDA to ensure that pharmaceutical supply chains are properly controlled.

Repercussions of Improperly Qualified Suppliers

When there’s a problem in the supply chain, products are not able to meet demand because of a lack of quality raw materials, clinical trials can be halted and amended, or program delays arise when the FDA inspections raise quality control issues – all good reasons to beef up supplier qualification.

Good manufacturing has always been about paying attention to the details, and by doing so, CMOs minimize the number of issues that can disrupt project completion. Because the stakes are so high, every CMO should take extra care in selecting and managing suppliers of their raw materials and outsourced services.

So how can today’s CMOs and other drug developers properly qualify suppliers to FDA standards, ensure project timelines and goals are met and ultimately ensure safe and effective final products?

Best Practices in Qualifying Suppliers

Conduct a self-evaluation questionnaire. Prior to selecting suppliers of goods and services, companies should require each of its suppliers to complete a questionnaire, which should provide important information to make an initial evaluation regarding the suitability and compliance of the supplier. The questions would address source and quality of raw materials, efficiency of processes, and evidence of existing quality systems.

Perform on site evaluations. For sources of critical supplies, it’s important to perform on-site quality audits of the supplier’s facilities, operations and quality systems. In the event that an on-site audit is not feasible, CMOs often can accept recent evidence of a quality system inspection by a regulatory body such as the FDA, European Medicines Agency (EMA) or other as a substitute for its own on-site visit.

Document the process. The Supplier Qualification process should be documented into Standard Operating Procedures reports by trained staff in order to properly perform an evaluation. These procedures may include a tiered system of risk assessment for all suppliers.

Recent FDA Changes Create Challenges for CMOs

For many years, careful selection and management of suppliers applied primarily to finished drug product manufacturers as they sourced APIs and excipients for their formulations.

In recent years, the FDA’s thinking on this subject expanded, with particular scrutiny extended further up the supply chain to those providing raw materials and critical reagents used in the manufacture of APIs.

The FDA’s requirement that suppliers be qualified earlier and earlier in the drug synthesis process makes the regulatory burden on CMOs and sponsors exceptionally challenging.

Adding to the challenge, producers of commoditized raw materials are neither easily reached nor willing to divulge their proprietary manufacturing processes. It can sometimes take a month to piece together the information required for a regulatory submission.

In light of the regulatory challenges, it’s important to have a deep bench of suppliers. We source materials from all over the world, favoring suppliers who can supply us reliably, at a high level of quality, and who are willing to provide the information needed for regulatory filings.

Whether or not regulations and enforcements are relaxed by the FDA in the future, establishing sound and adhered-to supplier qualification processes not only ensure safe and effective drugs, but they makes good business sense.