Tag: 14644

Risk-Based KPI Justification for Critical Validation Areas

Risk-Based KPI Justification for Critical Validation Areas Risk-Based KPI Justification for Critical Validation Areas The validation lifecycle in pharmaceutical manufacturing encompasses several critical steps designed to ensure compliance with regulatory expectations and maintain product quality. Among these steps, a focus…

Training Needs for CPV Automation and Tool Usage

Training Needs for CPV Automation and Tool Usage Training Needs for CPV Automation and Tool Usage Continued Process Verification (CPV) is an essential component in the lifecycle of pharmaceutical manufacturing, ensuring that processes remain in a state of control over…

Load Configuration Studies in Sterilizer Qualification

Load Configuration Studies in Sterilizer Qualification Load Configuration Studies in Sterilizer Qualification In the pharmaceutical industry, ensuring the integrity of aseptic processes is paramount. This step-by-step guide elucidates load configuration studies within the context of sterilizer qualification, adhering to ISO…

Handling Revalidation for Critical vs Non-Critical Equipment

Handling Revalidation for Critical vs Non-Critical Equipment Handling Revalidation for Critical vs Non-Critical Equipment The revalidation of equipment is a critical aspect of maintaining compliance in pharmaceutical manufacturing environments, particularly concerning the cleaning and environmental control standards outlined in ISO…

Writing a Site SOP for ICH Q9 Risk Implementation

Writing a Site SOP for ICH Q9 Risk Implementation Writing a Site SOP for ICH Q9 Risk Implementation In the highly regulated pharmaceutical industry, ensuring compliance with quality standards and regulatory requirements is crucial. This article provides a structured approach…

Analytical Method Transfer Risk Assessment Template

Analytical Method Transfer Risk Assessment Template Analytical Method Transfer Risk Assessment Template The process of transferring analytical methods, particularly in the pharmaceutical industry, must be executed with precision and a comprehensive understanding of quality assurance regulations. This step-by-step tutorial aims…

Regulatory Expectations for Steam Sterilization Systems

Regulatory Expectations for Steam Sterilization Systems Regulatory Expectations for Steam Sterilization Systems Steam sterilization is a critical process in pharmaceutical manufacturing, ensuring product safety and compliance with applicable regulatory standards. In this detailed tutorial, we outline the essential steps for…

Case Study: Blend Uniformity Failures and CAPA Implementation

Case Study: Blend Uniformity Failures and CAPA Implementation Case Study: Blend Uniformity Failures and CAPA Implementation Blend uniformity is critical in the pharmaceutical manufacturing process, ensuring consistent potency and efficacy of drug products. This article provides a comprehensive guide for…