In a complete supply chain, one site’s lag measure is another site’s lead measure. As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients. As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for many companies. In spite of the passage of the CARES Act (here), when assessing data integrity risks, there is an unexplained silence on the integrity of the data that is readily available to manage risks in a product’s supply chain.
Just over a year ago, the FDA published the statement, “FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain” (here). To assist industry, the Agency issued “Risk Management Plans to Mitigate the Potential Drug Shortages” (here). During the subsequent year, an abundance of activity has taken place (including, but not limited to):
- The Duke-Margolis Center for Health Policy launched the “Drug Supply Chain Resilience and Advance Manufacturing Consortium” (here), of which Lachman Consultants is proud to be a founding member.
- The final Q9(R1) Quality Risk Management was issued with increased detail around “Oversight of Outsourced Activities and Suppliers” (revision of the 2006 guidance).
- Note: See our previous blog post on risk of facilities management outsourcing here.
- USP 1083 “Supplier Qualification” has been rewritten and contains targeted text for assessing risk of suppliers in the supply chain (to become official on August 1, 2023).
- USP 1079 “Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products” will become official on December 1, 2023.
The FDA is exhibiting a high degree of transparency in projecting its intentions and inspection plans. This flurry of activity should be considered as a lead indicator for companies that rightly monitor the external regulatory environment. Lachman is at the forefront of risk assessment by assessing the integrity of lead indicators to help companies have actionable insight to understand risks in the overall supply chain.
Lachman encourages companies to start small but finish big for the patients. One step today in assessing your supply chain risks is 100% better than yesterday’s position. Reach out to Lachman at LCS@LachmanConsultants.com for help in assessing your supply chain risks and creating sustainable actions to address them.