Tag: GMP compliance

Dealing with Missing Calibration/Qualification History

Dealing with Missing Calibration/Qualification History Dealing with Missing Calibration/Qualification History In the pharmaceutical industry, validation activities are critical to ensure compliance with regulatory expectations and to maintain product quality. Missing calibration or qualification history for equipment can pose significant challenges…

Blend Uniformity in Multi-API and Low-Dose Formulations

Blend Uniformity in Multi-API and Low-Dose Formulations Blend Uniformity in Multi-API and Low-Dose Formulations In the pharmaceutical industry, ensuring blend uniformity is critical for maintaining the efficacy, safety, and quality of drug formulations, especially in multi-active pharmaceutical ingredient (API) and…

What to Include in a Legacy Equipment Qualification Protocol

What to Include in a Legacy Equipment Qualification Protocol What to Include in a Legacy Equipment Qualification Protocol In the pharmaceutical and biotech industries, the qualification of legacy equipment can present unique challenges, particularly in the context of cleaning validation…

Continuous vs Batch Process Considerations in Blend Uniformity

Continuous vs Batch Process Considerations in Blend Uniformity Continuous vs Batch Process Considerations in Blend Uniformity This step-by-step validation tutorial provides a comprehensive approach for pharmaceutical professionals involved in ensuring blend uniformity throughout the validation lifecycle. The focus will be…

Writing a Risk Assessment for Legacy Equipment Validation

Writing a Risk Assessment for Legacy Equipment Validation Writing a Risk Assessment for Legacy Equipment Validation In the pharmaceutical industry, ensuring compliance with regulations and standards is vital to maintaining quality and safety throughout the validation lifecycle. Legacy equipment, often…

Statistical Evaluation of Blend Sampling Data

Statistical Evaluation of Blend Sampling Data Statistical Evaluation of Blend Sampling Data This article presents a comprehensive step-by-step guide for the statistical evaluation of blend sampling data within the context of process validation in pharmaceutical manufacturing. This tutorial covers critical…

Qualification Strategy for Equipment Without URS or Drawings

Qualification Strategy for Equipment Without URS or Drawings Qualification Strategy for Equipment Without URS or Drawings In the pharmaceutical and medical device industry, the qualification of equipment is a critical process that ensures compliance with regulatory standards while maintaining product…

Regulatory Guidance (FDA, EMA, WHO) on Blend Homogeneity

Regulatory Guidance (FDA, EMA, WHO) on Blend Homogeneity Regulatory Guidance (FDA, EMA, WHO) on Blend Homogeneity In the pharmaceutical industry, ensuring quality through validated processes is non-negotiable. One critical aspect of pharmaceutical validation is assessing blend homogeneity. This article provides…

How to Qualify Legacy Equipment in Existing Facilities

How to Qualify Legacy Equipment in Existing Facilities How to Qualify Legacy Equipment in Existing Facilities The qualification of legacy equipment in pharmaceutical and medical device manufacturing facilities is a critical competency for Quality Assurance (QA), Quality Control (QC), Validation,…

Risk-Based Approach to Blend Uniformity Validation

Risk-Based Approach to Blend Uniformity Validation Risk-Based Approach to Blend Uniformity Validation In the pharmaceutical industry, ensuring consistent and uniform blending of active pharmaceutical ingredients (APIs) and excipients is critical to product quality and efficacy. This tutorial outlines a validated…