Regulatory Guidelines & Inspection Readiness

Presenting Data Trending and Continuous Monitoring to Agencies

Presenting Data Trending and Continuous Monitoring to Agencies Presenting Data Trending and Continuous Monitoring to Agencies The qualification of equipment in the pharmaceutical industry is a critical function, ensuring compliance with regulatory standards, assuring product quality, and safeguarding patient safety.…

Training Records and Validation Evidence Required During GMP Audits

Training Records and Validation Evidence Required During GMP Audits Training Records and Validation Evidence Required During GMP Audits In the pharmaceutical industry, especially within the context of regulatory inspections and audits, the importance of robust training records and validation evidence…

Using Risk Management to Justify Aseptic Process Decisions

Using Risk Management to Justify Aseptic Process Decisions Using Risk Management to Justify Aseptic Process Decisions The aseptic processing environment is critical in ensuring product safety and efficacy in pharmaceutical manufacturing. Implementing a robust validation lifecycle that adheres to regulatory…

How to Respond to Aseptic Process Audit Findings

How to Respond to Aseptic Process Audit Findings How to Respond to Aseptic Process Audit Findings Aseptic processing is a critical aspect of pharmaceutical manufacturing, particularly for sterile products. Given the complexity and risks associated with aseptic operations, regulatory bodies…

Regulatory Warning Letters for Isolator or RABS Failures

Regulatory Warning Letters for Isolator or RABS Failures Regulatory Warning Letters for Isolator or RABS Failures This comprehensive guide aims to provide pharmaceutical professionals with clear steps to ensure compliance with FDA and EMA guidelines, particularly in the context of…

Validation Lifecycle Expectations in EU vs US Aseptic Operations

Validation Lifecycle Expectations in EU vs US Aseptic Operations Validation Lifecycle Expectations in EU vs US Aseptic Operations In the highly regulated pharmaceutical industry, particularly in aseptic operations, a thorough understanding of the validation lifecycle is essential. Effective validation not…

Audit-Ready Documentation Flow for Aseptic Validation

Audit-Ready Documentation Flow for Aseptic Validation Audit-Ready Documentation Flow for Aseptic Validation Step 1: User Requirements Specification (URS) and Risk Assessment The foundation of any validation effort is the User Requirements Specification (URS). The URS outlines the specific requirements that…

How to Handle Media Fill Failures During an Inspection

How to Handle Media Fill Failures During an Inspection How to Handle Media Fill Failures During an Inspection In the pharmaceutical industry, ensuring the integrity of aseptic processes is critical. Media fill tests are essential components of process validation, particularly…

Regulatory Emphasis on Contamination Control Strategy (CCS)

Regulatory Emphasis on Contamination Control Strategy (CCS) Regulatory Emphasis on Contamination Control Strategy (CCS) As the pharmaceutical industry continues to evolve, the emphasis on effective contamination control strategies (CCS) remains paramount, especially in sterile manufacturing. The guidelines provided by Eudralex…

Cleanroom Behavior Training and Regulatory Expectations

Cleanroom Behavior Training and Regulatory Expectations Cleanroom Behavior Training and Regulatory Expectations This article provides a comprehensive, step-by-step tutorial on validation in cleanroom environments, particularly focusing on cleanroom class 1 settings. Designed for QA, QC, and Validation teams within the…