Air Emissions Monitoring (LDAR, VOCs): Evidence FDA/EPA Auditors May Request in 2023 Air Emissions Monitoring (LDAR, VOCs): Evidence FDA/EPA Auditors May Request in 2023 In the complex landscape of pharmaceutical regulation, compliance with environmental standards is paramount. Air emissions monitoring, particularly concerning Leak Detection and Repair (LDAR) and Volatile Organic Compounds (VOCs), represents a critical area for regulatory adherence. This guide outlines the step-by-step process needed to meet the expected requirements and prepares you for audits by the FDA and EPA. Each stage in this guide will provide practical actions, necessary documentation, and insights into what regulators are likely to…

PFAS and Emerging Contaminants: How Pharma Should Prepare in 2023 PFAS and Emerging Contaminants: How Pharma Should Prepare in 2023 As the regulatory landscape evolves, pharmaceutical companies must navigate the complex challenges posed by per- and polyfluoroalkyl substances (PFAS) and other emerging contaminants. With increasing scrutiny from environmental agencies, understanding compliance requirements is imperative for sustaining operations and ensuring public health. This guide outlines step-by-step strategies for preparing for and managing compliance with regulations concerning PFAS and other emerging contaminants in the pharmaceutical industry. Step 1: Understanding Emerging Contaminants and Regulatory Frameworks Emerging contaminants represent a wide array of chemicals,…

Disposal of Controlled Substances: DEA + EPA Compliance Workflow for 2023 Disposal of Controlled Substances: DEA + EPA Compliance Workflow for 2023 In the pharmaceutical and healthcare industries, the disposal of controlled substances is a critical aspect of environmental and safety compliance. Adhering to the regulations set forth by the Drug Enforcement Administration (DEA) and the Environmental Protection Agency (EPA) is essential for maintaining the safety and integrity of waste management processes. This step-by-step tutorial will guide you through the compliance workflow necessary for the proper disposal of controlled substances, ensuring your organization meets all legal obligations while promoting environmental…

Environmental Complaint Handling: How to Build an Investigation SOP for 2023 Environmental Complaint Handling: How to Build an Investigation SOP for 2023 In the pharmaceutical industry, compliance with environmental regulations is crucial. This article provides a comprehensive step-by-step tutorial on how to build an effective Standard Operating Procedure (SOP) for handling environmental complaints. It is tailored for professionals in EHS compliance consulting, including regulatory affairs, quality assurance, and supply chain management. By the end of this guide, you will have a clear understanding of how to structure your SOP and ensure it meets all regulatory expectations. Step 1: Understand Regulatory…

ZLD and Advanced Treatment Options: Commercial Feasibility + Compliance Notes for 2023 ZLD and Advanced Treatment Options: Commercial Feasibility + Compliance Notes for 2023 As environmental challenges intensify, pharmaceutical companies are increasingly focusing on advanced treatment options that align with environmental sustainability and regulatory compliance. This article provides a step-by-step guide on implementing Zero Liquid Discharge (ZLD) systems and advanced treatment options in the United States, addressing critical compliance notes and commercial feasibility considerations for 2023. It is essential for professionals engaged in EHS compliance consulting, environmental and safety management, and regulatory affairs to understand the complexities of these systems….