Life Sciences

Lessons from 483s: Essential Strategies for Medical Device Manufacturers 

by | Apr 3, 2024 | , ,

Streamline CFR Part 820 compliance for medical devices. Merit for Life Science tackles CAPA, complaints & training for smoother FDA inspections. Introduction As a medical device leader, ensuring FDA compliance is paramount. It safeguards product safety, patient well-being, and your business from costly citations. However, navigating the complexities of FDA regulations can be daunting. Merit for Life Science simplifies this process.  The Challenge: Avoiding Costly FDA Citations  A closer examination of Form FDA-483 or FDA 483 Warning Letters reveals the most common reasons medical device manufacturers are issued a 483. Since 2015, 38% of citations (4,568 to be exact!) stemmed from just two areas:  21 CFR Part 820.100(a): Corrective and Preventive Action (CAPA)...

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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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Safeguarding Success: Controlling Storage Conditions at Biotech and Pharma Facilities 

by | Feb 29, 2024 | , , ,

In this four-part blog series, we explore how Merit for Life Science optimizes critical business processes for pharmaceutical and biotech companies by advancing the core capabilities of Microsoft Dynamics 365 with a professionally developed, tested, and validation-ready solution. Read our other blogs on inventory management and product safety, weighing and dispensing, and inventory splitting and sub-batching. Imagine the scene: a life science manufacturer eagerly anticipates the launch of a groundbreaking therapy. But suddenly, disaster strikes. A storage mishap in one of the warehouses compromises the product’s integrity, rendering it ineffective and jeopardizing not only patient health but also the company's reputation and bottom line. This hypothetical scenario underscores why...

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The Power of Simplified Inventory Splitting and Sub-Batching

by | Feb 22, 2024 | , , ,

In this four-part blog series, we’ll explore how Merit for Life Science optimizes critical business processes for pharmaceutical and biotech companies. See our other blogs on inventory management and product safety, weighing and dispensing, and controlling storage conditions.  In the world of pharmaceuticals and biotech, where every detail matters, inventory management isn't just a task—it's a critical part of the story. Precision is paramount and regulations are strict. Here, inventory splitting and sub-batching play a vital role in ensuring efficiency and compliance. By efficiently managing batches and materials through sub-batching, your organization can better ensure traceability, minimize risks associated with quality deviations, and streamline processes throughout the supply chain....

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6 ERP “Must Haves” for Tracking Chain of Custody within the Autologous CGT Industry 

by | Feb 15, 2024 | , , , , , ,

In the autologous* cell and gene therapy (CGT) industry, tracking the path from patient to product is not just a regulatory requirement; it's at the heart of patient safety and product integrity. An Enterprise Resource Planning (ERP) system plays a crucial role in this process.  *(Lonza does a nice job of explaining the difference between autologous and allogeneic cell therapies here.)   Here are six essential features an ERP system should possess to ensure a reliable chain of custody: Patient Data Management and Sample Control  Supply Chain Optimization  Storage Controls  Electronic Batch Records Real-time Tracking and Traceability   Dynamic Demand Forecasting  Patient Data Management and Sample Control  Patient sample control is the...

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