Tag: pharma validations

Troubleshooting Incomplete or Lost Logger Data

Troubleshooting Incomplete or Lost Logger Data Troubleshooting Incomplete or Lost Logger Data In the pharmaceutical industry, ensuring data integrity during transport and storage is paramount. Data loggers are essential in monitoring environmental conditions to maintain product quality. However, data integrity…

Air Permeability and Leak Rate Acceptance Criteria

Air Permeability and Leak Rate Acceptance Criteria Air Permeability and Leak Rate Acceptance Criteria Air permeability and leak rate acceptance criteria are crucial aspects of pharmaceutical packaging validation processes. Appropriate evaluations and qualifications ensure that the packaging systems effectively protect…

Regulatory Expectations for Trending Environmental Data

Regulatory Expectations for Trending Environmental Data Regulatory Expectations for Trending Environmental Data In the dynamic landscape of pharmaceutical manufacturing, effective validation processes are critical to ensure compliance with regulatory expectations. This guide provides a comprehensive step-by-step tutorial for pharma validations…

Linking Cleaning Validation to Equipment Logs and Batch Records

Linking Cleaning Validation to Equipment Logs and Batch Records Linking Cleaning Validation to Equipment Logs and Batch Records In the pharmaceutical industry, effective cleaning validation is essential to ensure product integrity and compliance with regulatory standards. The intricacies of the…

Regulatory Expectations for VMPs at CDMOs

Regulatory Expectations for VMPs at CDMOs Regulatory Expectations for VMPs at CDMOs Step 1: Understanding the Purpose of a Validation Master Plan (VMP) In the realm of pharmaceutical development and manufacturing, a Validation Master Plan (VMP) serves as a foundational…

Common Data Integrity Violations Found in CSV Audits

Common Data Integrity Violations Found in CSV Audits Common Data Integrity Violations Found in CSV Audits In the highly regulated pharmaceutical and biologics industries, ensuring the integrity of data captured during the computer system validation (CSV) process is paramount. With…

Critical Utilities Qualification: Where to Start

Critical Utilities Qualification: Where to Start Critical Utilities Qualification: Where to Start Critical utilities play an essential role in the pharmaceutical manufacturing process. Understanding how to properly validate these systems is crucial for ensuring compliance with stringent regulatory standards. This…

CPV Review Frequency: Monthly, Quarterly, or Annually?

CPV Review Frequency: Monthly, Quarterly, or Annually? CPV Review Frequency: Monthly, Quarterly, or Annually? Continued Process Verification (CPV) is an essential component of a robust pharmaceutical validation strategy, ensuring the consistent quality of products in line with FDA Process Validation…