Quality and Compliance

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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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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How Life Science CDMOs are Using Cloud Computing to Create Differentiation

by | Jan 25, 2024 | , , , , , , ,

Contract development and manufacturing organizations (CDMOs) are experiencing new entrants and capacity expansion, leading to the need to create and maintain differentiation in service offerings to stay competitive. With change comes opportunity, and the strategic implementation of digital infrastructure is crucial for staying competitive. In this blog, we'll explore four reasons why CDMOs are increasingly moving to cloud applications to run their enterprise business and the benefits of cloud applications.  Capacity Expansion Differentiation and Competition  People and Collaboration  Quality, Speed, and Confidence Capacity Expansion  Until recently, biopharma contract development and manufacturing faced a significant capacity shortage. Procuring contract development...

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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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Merit Solutions helps life science companies create and manage documents with Microsoft Azure

by | May 19, 2022 | , , ,

New document management and control solution enables internal and external collaboration while meeting the most rigorous standards in a trusted Microsoft secure cloud environment We're pleased to share that Merit GxP Documents is now available. This monthly subscription-based Software as a Service (SaaS) document management and control solution helps life science organizations follow GxP guidelines, ISO standards, and maintain FDA compliance. It can be used stand-alone or as part of the broader Merit for Life Science and Microsoft Dynamics 365 ERP solution.  Merit GxP Docs offers biopharma and medical device companies a solution that is easily adopted by early-stage companies and scales to meet the needs of enterprises.Bill Burke, CEO of Merit Solutions “Working with an app that helps...

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