bioanalytical method validation

Root Cause Analysis for Cold Chain Deviations

Root Cause Analysis for Cold Chain Deviations Root Cause Analysis for Cold Chain Deviations In the pharmaceutical and biologics industries, maintaining the integrity of products throughout the cold chain is critical. Any deviation can lead to significant regulatory, financial, and…

Print Quality Validation for 2D Codes, Datamatrix & Barcodes

Print Quality Validation for 2D Codes, Datamatrix & Barcodes Print Quality Validation for 2D Codes, Datamatrix & Barcodes In today’s pharmaceutical landscape, ensuring product integrity through effective print quality validation for 2D codes, DataMatrix, and barcodes is essential. This article…

Smoke Study for Airflow Visualization and Laminarity

Smoke Study for Airflow Visualization and Laminarity Smoke Study for Airflow Visualization and Laminarity In the pharmaceutical industry, the validation of environmental control systems is indispensable for ensuring product quality and regulatory compliance. A critical aspect of this validation process…

How to Ensure Data Integrity in Validation Records

How to Ensure Data Integrity in Validation Records How to Ensure Data Integrity in Validation Records In the pharmaceutical and biotechnology industries, ensuring data integrity throughout the validation lifecycle is crucial for compliance with regulatory standards such as those set…

FDA and EU Guidelines for VMPs: Comparison and Contrast

FDA and EU Guidelines for VMPs: Comparison and Contrast FDA and EU Guidelines for VMPs: Comparison and Contrast Step 1: Understanding the Validation Master Plan (VMP) The Validation Master Plan (VMP) serves as a foundational document in the pharmaceutical industry,…

How to Validate Excel Calculations Used in GMP Operations

How to Validate Excel Calculations Used in GMP Operations How to Validate Excel Calculations Used in GMP Operations In the highly regulated pharmaceutical industry, the accuracy and reliability of data generated through Excel calculations are paramount. This article provides a…

What to Include in a Deviation Log for Qualification Activities

What to Include in a Deviation Log for Qualification Activities What to Include in a Deviation Log for Qualification Activities In the pharmaceutical industry, maintaining compliance with regulatory requirements is paramount for ensuring the quality, efficacy, and safety of products.…

Key Elements of a Good Process Validation Report

Key Elements of a Good Process Validation Report Key Elements of a Good Process Validation Report Process validation is an essential part of the pharmaceutical development and manufacturing lifecycle. It not only guarantees product quality but also ensures compliance with…