Compliance Team

A Thanksgiving message from our CEO.

The Drug Supply Chain Security Act will be in full force by November 27th, 2024. Any pharmaceutical manufacturers, wholesalers, and dispensers must be ready to comply with the new, critical requirements. Here's everything you need to know about the DSCSA including how to fully comply by the upcoming deadline: https://lnkd.in/eNsayM_C. #DSCSA #Pharma #LifeSciences #Manufacturing #Compliance #ComplianceTeam #Pharmaceutical

Compliance Questions?? Candid Answers! (#22) ?? What big changes are here for over-the-counter (OTC) drug manufacturers? ? ?? The FDA’s OTC Monograph Reform, part of the 2020 CARES Act, is completely reshaping how over-the-counter drugs are regulated—and it’s rolling out now. If you're in the OTC space, here's what you need to know: ?? Faster Approvals: Say goodbye to the old, slow process. The FDA now uses an administrative order system for faster approvals of new ingredients and updates to OTC products, cutting years off the traditional monograph update process. ?? Innovation-Friendly: Companies can more quickly introduce new OTC products or make changes to existing ones—no need to wait for lengthy rulemaking. ?? User Fees Have Arrived: The Over-the-Counter Monograph User Fee Act (OMUFA) is charging fees that fund faster approvals but create new costs. ?? Annual Facility Fees: ~$20,000 - $25,000 per facility, will be charged yearly. ??Order Request Fees: For submitting changes or new ingredients, adding more upfront costs for innovation. ?? Heightened Safety Standards: The FDA now has the power to quickly withdraw unsafe products or update monographs based on new safety data. Expect stricter enforcement of safety requirements, labeling, and manufacturing practices. ??Timeline: 2021: User fees went into effect. 2022-2023: Full implementation of the new user fees and faster approval. 2024: Increased compliance and enforcement of the new rules as the FDA ramps up oversight. ??Compliance Challenges: ?? Cost Burden: Smaller manufacturers may struggle with the annual fees and submission costs, adding pressure to stay competitive. Facility Registration & Fees: Missing fee deadlines could land companies on the “Ineligible for Operations” list, halting production. ?? Post-Market Surveillance: Companies must maintain rigorous post-market monitoring and respond quickly to FDA safety alerts, recalls, or required label changes. ?? Data Requirements: Expect more scrutiny on safety and efficacy data, requiring detailed documentation and faster response times to FDA requests. This reform means more opportunities for innovation but also new compliance hurdles and costs. Is your company ready to navigate this new landscape? Compliance Team is always here to help. #OTCMonographReform #LifeSciences #FDACompliance #Pharma #OTC

Find out everything you need to know about quality risk management including: ? How To Create A QRM Process ? How To Document Risk Assessments ? QRM-Related Keywords You Should Know and more! Check out the latest post here: https://lnkd.in/eZqzSe3E. #LifeSciences #Compliance #QRM #Manufacturing #Pharma #Pharmaceutical #Medical

The FDA expects the use of quality techniques, including statistics, to guide risk-based, science-based decision-making. There is no better way to demonstrate that accurate decisions were made using objective statistical methods. Read more about how to simplify Statistical Techniques For Quality Management: https://lnkd.in/e8BQexCq #ComplianceTeam #Compliance #QMS #LifeSciences

Attention CDMOs: Compliance Team can help you with regulatory expertise, validation resources, and quality audits. Remember that we consult with customers like yours every day, and can help your projects run smoothly and stay on time. We'll be at the Contract Pharma Contracting & Outsourcing Conference in New Brunswick, NJ on September 26th. Feel free to message us and let's connect! #Compliance #QualityControl #FDA #QualityAudits #ComplianceTeam

Compliance Questions?? Candid Answers! (#18) ?? What is a data integrity violation and how does mismanaged data cause problems for pharmaceutical manufacturing? ? Data integrity violations can compromise the safety, efficacy, and quality of pharmaceuticals. FDA places a high emphasis on data integrity as it ensures the reliability and transparency of the entire drug manufacturing process. Here are some of the most common problems associated with poor data management. ? ? Hindering Quality and Patient Safety ?? Inaccurate Test Results: Data issues often arise in laboratories, where test results may be falsified or manipulated. This can lead to the release of products that do not meet quality specifications leading to unsafe medications being released. ??Missed Contamination: Falsified or incomplete data can hide evidence of contamination or impurities, potentially leading to severe adverse effects. ??Poor Accountability: Data manipulation prevents accountability in identifying the root causes of production issues. This lack of traceability makes it difficult to ensure corrective and preventive action. ?Lack of Trust with Regulators ??Warnings and Import Alerts: If data integrity issues are discovered during FDA audits, companies may face serious issues, including warning letters, import bans, and injunctions. ??Increased Scrutiny : A history of data integrity violations can lead to stricter oversight, delaying regulatory approvals for new drug applications (NDAs) or clinical trials. The FDA may require re-inspection. ?Failure to Identify and Correct Deviations ??Inadequate Reporting: When data integrity is compromised, it becomes difficult for the quality department to identify and properly investigate from current SOPs. ??Inadequate Corrective Actions: Without reliable data, the root cause of deviations may not be understood, making it impossible to implement effective corrective and preventive actions (CAPA). ?Technology Gaps and IT Systems ??Outdated Systems: Issues often arise from reliance on outdated IT systems that lack controls for electronic records, such as audit trails or restricted user access. Failure to upgrade systems leads to higher risk of data manipulation or loss. ??Inadequate System Validation: Manufacturing systems and software must be properly validated to ensure they function as intended and maintain the integrity of recorded data. Gaps in validation can lead to incorrect record-keeping, or inaccurate batch records. ??Lack of Audit Trails: Failure to produce audit trails for electronic records can allow unauthorized changes to critical data without traceability. Data integrity is the backbone of trust in pharmaceutical manufacturing. Manufacturers must prioritize robust systems, transparent processes, and a strong culture of compliance. Regular audits, employee training, and updated IT systems are essential for mitigating these risks.

Supply chains are ever-increasing in complexity. Today, it is especially crucial to understand potential disruptions, such as delays, damaged products, partner resistance, and regulatory challenges when managing a supply chain. If you want to know how to manage your supply chain effectively, take a look at these top five best practices: https://lnkd.in/gzHisAaz #SupplyChain #Medical #Manufacturing #Pharma #Pharmaceutical #Compliance #LifeSciences

Compliance Questions?? Candid Answers! (#17) ?? How does a drug or medical device manufacturer repair reputational harm after a medical product recall? ? Managing reputational damage from a recall requires a well-planned and transparent approach that prioritizes patient safety and maintains public trust. Some of the largest, global drug/device companies have faced several high-profile recalls. The objective is to give you examples of how global players have managed the fallout. One notable case is the 2010 recall of the Johnson & Johnson DePuy ASR hip implants. Actionable steps your RA/QA and Communications departments can follow: ? Immediate Action and be Transparent ?? Recall Announcement: When Johnson & Johnson recalled the implant, they made the announcement publicly, including patients, healthcare providers, and regulators. They communicated the reasons for the recall clearly, citing data that showed a higher-than-expected failure rate. ??Patient Outreach: J&J contacted patients directly, offering guidance on what steps to take if they had the implant. This included consulting with their healthcare providers. ? Focus on Patient Safety ??Medical Support: J&J offered to cover the costs associated with monitoring and revision surgeries for patients affected by the faulty implants. ??Establishment of a Helpline: The company set up a helpline to answer questions from patients and healthcare providers. This move helped manage the spread of misinformation. ? Legal Management ??Settlement/Compensation: Johnson & Johnson faced numerous lawsuits. They opted to settle many of these cases, agreeing to pay billions in compensation. This allowed the company to address patient grievances and legal challenges. ??Cooperation with Regulators: J&J worked closely with regulatory bodies like the FDA, providing them with necessary data and updates on the recall. This helped to mitigate more regulatory scrutiny. ? Public Relations and Rebuilding Trust ??Public Apology: J&J publicly acknowledged the issues with the hip implants and apologized to those affected. They admitted to the problem and outlined the steps they were taking to rectify the situation. ??Investment in Quality: After the recall, J&J increased its investment in quality assurance processes and began implementing more rigorous testing and monitoring. ?Long-Term Reputation Management ??Rebranding and Product Innovation: To distance itself from the negative associations of the recall, J&J focused on innovation and introduced new products with improved safety profiles. They also rebranded some of their product lines to show a fresh start. ?Lessons Learned Despite the reputational damage caused by the hip implant recall, J&J retained its position as a leading healthcare company. Their approach to combining transparency, patient support, legal resolution, and long-term quality improvements helped improve the crisis. #ProductRecall; #ReputationalRepair; #FDA; #ComplianceTeam

Counterfeit medication is a worldwide problem. Many of us in the United States may be surprised to realize that, the World Health Organization (WHO) has estimated that?$21 billion worth of drugs are counterfeit. It’s no wonder that countries are implementing serialization requirements to discourage counterfeiters by making counterfeit products more detectable. Learn more about the importance of serialization in the medical world and how it plays a role in the process of reducing counterfeit drugs: https://lnkd.in/egCDCZDk #Medical #Pharma #Pharmaceutical #LifeSciences #WHO #Manufacturing #Health #Compliance