The FDA exhibits a high degree of transparency in projecting its intentions and inspection plans. One has only to look at publications such as, “An update to the Resiliency Roadmap for FDA Inspections” (here) that was issued November 2021. So, one may ask, what has happened in the meantime and what is the plan for 2023? This blog may help during this time as companies sort and deploy their 2023 objectives.

As the COVID fog lifts, industry, agency, and patients try to look into the future. Proactivity, long seen as the most cost-efficient way for real compliance, has been supported by activities such as:

• Risk Management
• Quality Management Maturity

However, many companies need assistance in creating an executable year-to-year plan to “be” proactive and “stay” proactive, truly understanding the needs of their stakeholders. Insight can be gained by a recent FDA presentation that demonstrates simple agency direction for 2023 (outlined below), in accordance to its published roadmap:

• Resume routine world-wide operations in FY 23
• Increased focus on management responsibility and risk management

Putting it together for 2023 (and forward) can be assisted by understanding the “how.” In October 2022, the FDA updated its “Drug Manufacturing Inspections,” CPM-7356.002. When integrating the aspiration of Quality Management Maturity, Risk Management, and good business practices, the industry leaders would be advised to include items from the CPM such as: Indicators of an Advanced Quality System, Management Responsibility, Supply Chain and Contracted Service management, analytics used in Quality Oversight, operational risks, and employee feedback, only to name a few.

The focus on Management Oversight is of particular interest as is provides considerable flexibility in deployment but raises the visibility of “what did management know” and “when did they know.” Many QMS depend on “process” however this area is dependent on “output” and “data.” Immense opportunity exists in this space by integrating data governance, risk management, and management review.

Lachman has written much about these programs in 2022, and signals are quickly emerging that strategic action is needed to keep in line with agency strategy (see here).

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Patrick Day, M.S. is a Principal Consultant in the Compliance Practice at Lachman Consultants and an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment as well as in leading the rollout of computer validation for vaccines, aseptic antibiotic, and cytotoxic operations. Mr. Day is well versed in FDA and MHRA regulations. He has trained FDA field inspectors for facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise includes in-house execution as well as outsourcing and governance of FM and laboratory services across US/UK and Asia-Pacific.