Articles on analytical & statistical methods, process analytical technology - BioPharm International

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Quality
Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT).

Industry Seeks Clearer Standards for Track and Trace

July 1, 2014

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Optimizing Human Performance: Part I

July 1, 2014

Achieving excellence in human performance is an achievable system of cultivating and sustaining exceptional levels of performance.

Ensuring a Robust Raw-Materials Supply Chain

July 1, 2014

With globalization, biopharmaceutical companies must establish strategies to minimize vulnerabilities in the raw-materials supply chain.

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

Challenges in Analytical Method Development and Validation

June 1, 2014

Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.

Linking Drug Shortages and Quality Metrics

May 1, 2014

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

March 1, 2014

This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.

Defining Quality Metrics is No Easy Task

February 1, 2014

ISPE and PDA take on the challenge of recommending quality metrics.

Progress in the Prediction of Protein Aggregation

January 1, 2014

Techniques to enable the design and formulation of stable, protein-based therapeutics.

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