Drug Development

Articles

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

FDA Publishes Revised Process-Validation Guidance

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

The Role of Bioburden in the Contamination-Control Plan

Sometimes doing what you think is right ends up being completely and utterly wrong.

Wasting More Than Time

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

Balancing Act

Maik Guttzeit is Head of Quality Assurance at GEA Pharma Systems, Germany.Tel: +49 2233 6999 401 

This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.

Designing An Effective PAT-Driven Scale-Up Of Lyophilization Processes

From disagreement to denial, being cordial about quality control can be challenging.

Communication Quandaries

The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.

Strategic Approaches to Process Optimization and Scale-up

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

No More Exceptions

The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

Microstructured Reactors for Rapid Process Development and Scale-Up

Cases of overlooking proper packaging, reconstitution, directions, and dissolution.

Process and Scaling