Business Insights

Lessons from 483 Inspections: CFR 21 Part 211

by | Mar 15, 2024 | , , , , , ,

In the highly regulated world of drug and biotechnology manufacturing, adhering to FDA regulations is essential not just legally, but also for protecting patient health, ensuring quality and building market trust. This blog highlights a critical trend: over 50% of the compliance issues noted during FDA Inspections (as documented in 483 Letters) for drug manufacturers (including some biotechnology firms) have focused on specific sections of FDA CFR 21 Part 211. This indicates a crucial area for compliance improvement to maintain operational integrity and uphold industry standards.  Understanding CFR 21 Part 211 and Recent Observations:  FDA CFR 21 part 211 outlines the regulations for the manufacturing, processing, packing, or holding of drug...

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Lessons from 483 Inspections: Navigating FDA Compliance for Drug and Biotech Manufacturers

by | Mar 14, 2024 | , , , , ,

In the biopharmaceutical industry, ensuring public health and product safety is paramount. Regular inspections by the Food and Drug Administration (FDA) are crucial to this mission. Even for established companies, the prospect of receiving a Form 483 (a document outlining potential compliance issues) following an inspection can be nerve-wracking.  Common Areas of Non-Compliance The FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) publish annual data on the number of 483s issued and aggregated data on the particular types of issues cited in the 483 letters. While each individual 483 letter is unique, looking at the data in aggregate reveals recurring themes, such as:  Quality systems: Deficiencies in quality...

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Is Your ERP Holding You Back? Unleash Your Organization’s Innovation

by | Jan 11, 2024 | , , ,

You rely on your ERP system to support your life science business, but lately, you’re starting to question if it’s supporting you as effectively as it could. And you suspect that your ERP won’t be able support you in hypergrowth mode.   What are the warning signs that you’ve outgrown your current ERP system? As we’ve worked with biotech, pharma, and medical device manufacturing customers who are considering moving to a new ERP system, we've seen some familiar signals that affected their ability to reach the levels of growth and leadership they were seeking. Here are four signals that might be spotted in your organization, too. Four Warning Signs Your ERP is Holding You Back: Lack of flexibility Ineffective collaboration Lack of decision-making information Inaccurate data Get...

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5 Critical Metrics That Can Make or Break a Biopharma’s Year

by | Sep 13, 2022 | , ,

This week we look at five critical operational metrics that can make or break a biopharma manufacturer's year. Ones that, as the business grows beyond small business accounting packages and manual processes, biopharma leaders often struggle to measure: Vendor Delivery PerformanceCustomer Delivery PerformanceManufacturing Schedule performanceQuality Management impactQuality Audit Performance Often, we see organizations fail to monitor these KPIs because they are growing fast, and their existing systems cannot keep up or they do not have the functionality needed to drive and sustain manufacturing excellence. Let’s explore how the right digital platform can be the difference between manufacturing excellence and missed opportunity. 1. Vendor Delivery Performance Managing the supply chain to...

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Five Top Reasons Digital Infrastructure Drives Biopharma Company Value

by | Nov 16, 2021 | , ,

Merit customers continually tell us that digital infrastructure is one of their major determinants of company value when they raise capital or get acquired. One Merit customer, a late clinical-stage biotech with an injectable aesthetics therapy, intimated that having Merit and Microsoft's digital infrastructure in place increased their acquisition price by $500M.  In contrast, last month, another late-stage, biotech that did not invest in necessary digital infrastructure lost $635M in enterprise value, dropping 39% in their stock price in one day. This drop came from FDA audit observations indicating a lack of control and data completeness, which caused their product not to get approved for commercial offering. (Incidentally, this was not a Merit Solutions customer.) How do you...

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Change Management and Merit Solutions: Perspectives and Practices

by | Aug 30, 2021 | , ,

You’ve been called to a meeting to kick off an ERP implementation. Executives are present, along with divisional leaders and a handful of the company’s brightest employees. The discussion kicks off with an executive who states: “Over the next 6 to 12 to 18 months, we’re going to change our current software. We’ll automate paper processes, build in protection to ensure passing FDA audits, and much more. All it will take is...” At this moment, you're not thinking about the SOPs or the warehouse handhelds. Like any great leader, you’re thinking about the impact on your people. How do you ensure that your team not only survives but thrives through the implementation of an ERP solution? Success hinges on change management as part of a well-managed project. Effective Change Management Change...

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