Quality and Compliance

GxP Training: Its Vital Role in Regulated Industries 

by | Jul 30, 2024 | , , , ,

GxP training isn't just a checkbox; it's the key to safeguarding your life science supply chain, protecting patients, and securing your company's future. It's 3 AM. In a pharmaceutical plant, a team works diligently to produce a life-saving drug. Suddenly, a critical error occurs because a new hire, overwhelmed and undertrained, mishandles a key process.   This scenario isn't just a nightmare; it's a reality that many in the life sciences industry face. In highly regulated industries like pharmaceuticals, biotech, and medical devices, the stakes are incredibly high. Effective training isn't just a box to tick; it's a lifeline that ensures safety, compliance, and operational excellence.  The Crucial Role of GxP Training Management  Training management in regulated...

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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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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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