If you manufacture pharmacueticals or devices, there are several risks that could impair your business and / or jeopardize your compliance. You’re already monitoring many of them, but here are a few that may require more scrutiny.

  1. FDA guidelines. The FDA has issued guidelines for Continued Process Verification (CPV). The Agency is very interested in the way you control processes and ensure quality.
    POTENTIAL RISK: Are you prepared for an FDA audit of your CPV program?
  2. SEC scrutiny. Regulatory scrutiny is not limited to the FDA; the Securities and Exchange Commission (SEC) is also paying more attention. At a national compliance conference in 2015, the SEC’s Director of Enforcement called the pharmaceutical industry “one on which we have been particularly focusing.”1 An emerging concern is compliance with SEC Rule 10b-5, which requires the reporting of all “material” business information and risks that an investor may find crucial when making a decision to buy, hold or sell stock. Issues such as product recalls and material supply shortages must be disclosed. New inquiries are made into areas such as the sufficiency of supply and quality agreements on issues like process control, data integrity, protection of manufacturing intellectual property (IP) and noncompetes.
    POTENTIAL RISK: Do you fully understand your risks and have the expertise to navigate SEC compliance?
  3. Data integrity. With increased FDA attention on process control and understanding, more data integrity 483 violations are being handed out. These are directly linked to not establishing and/or following procedures required for cGMP compliance. This becomes even more challenging with contract manufacturers who may have separate data systems and quality procedures. Drug owners and their external manufacturing partners must work closely to ensure the right procedures and training are in place to avoid data integrity issues. The FDA draft guidance2 recommends utilizing a third-part auditing firm to assess and remedy data integrity issues.
    POTENTIAL RISK: Are your internal audits and contract supplier audits sufficient to prevent data integrity issues?
  4. Supply and Quality Agreements. Supply and quality agreements define the obligations between product owner and manufacturing partners. The best agreements not only specify roles, responsibilities and terms related to quality, cost and delivery – they also address other critical risk factors such as ownership of manufacturing data and IP, how data will be shared and post-patent expiry competition.
    POTENTIAL RISK: Do your agreements support successful manufacturing partnerships and enable compliance with FDA regulations regarding process control?
  5. M&A. Life science manufacturers often use several IT solutions to support production and testing processes—systems either built, bought or inherited through mergers and acquisitions. While this technology may be getting the job done now, it might be insufficient as your requirements for data capture, analysis and reporting grow.
    POTENTIAL RISK: How effectively does your IT architecture and software portfolio support your long-term business objectives and compliance requirements?

Assess Your Manufacturing Risks

When manufacturing risks go undetected, the consequences can be serious: product recalls and shortages, failed tech transfer, FDA or SEC violations, lawsuits, loss of market value and more. You’ll be in a stronger position to manage these risks if you’ve conducted a thorough Manufacturing Risk Assessment™. To insure a comprehensive MRA, look for an organization with these qualities.

  • Industry Experience. Choose advisors who have experience in manufacturing drug products and devices and understand your unique challenges.
  • Holistic Perspective. Select a team that will view your situation from multiple points of view—applying manufacturing, data science, quality, IT, legal and business expertise.
  • Analytical Capabilities. Secure a data-driven assessment from a team that understands the role of IT and analytics in manufacturing and quality management.
  • Flexibility. Work with a provider that will tailor the MRA to your needs. For example, if a cGMP audit has been done recently, the focus might be on data integrity, IT and analytical systems.
  • Action-oriented. An assessment is just the first step. Make sure your provider is able to give you an action plan to mitigate any risks uncovered in the analysis.

Protect and Optimize Your Business

Risks are on the rise in the life science manufacturing sector. Some are quite obvious; others may be flying under the radar. As a leader of, or advisor to, a life science manufacturer, you may be held accountable for identifying, managing and disclosing risk. Invest in a MRA™ from Skyland Analytics to limit your liabilities, uncover opportunities and put your business on a path to profitable growth.

1. http://www.sec.gov/news/speech/2015-spch030315ajc.html
2. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf

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