Quality Control/Quality Assurance

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Upstream processing is better optimized with the help of automated workflows.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

New and emerging biotherapeutic molecules drive the need for innovative solutions to meet cold-chain requirements.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

Fully automated enzyme analysis can ease a persistent bottleneck in biocatalyst development for bio/pharmaceutical applications.

Confounding signals pose challenges to analytical methods necessary for managing residual impurity removal in biotherapeutic manufacturing.

Glycosylation monitoring has been heavily dependent on manual processes, but the automation of sample preparation streamlines the overall workflow.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

COVID-19 created challenges for quality control departments. How have the lessons learned from the pandemic influenced the way companies use technology to perform quality-control procedures?

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

Siegfried Schmitt, vice president, Technical at Parexel, comments on the new paradigm of remote audits.

Public health challenges have highlighted the need for agility in maintaining the quality of medicines.

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.

BioPharm International asked Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, about how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.