Drug Development

Articles

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

US Marshals Seize Unapproved Drugs

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

MHRA Revises Data Integrity Guidance

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

EMA Releases Medication Error Guidelines

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Industry awaits the final revision of USP General Chapter  and the impact it will have on the evaluation of sterile product package integrity.

Evaluating Package Integrity

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

Modernizing Scale-Up

Fernando J. Muzzio, PhD, is a professor and the director of the pharmaceutical engineering program at the Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854-8058, tel. 732.445.3357.

Engineering Research Center for Structured Organic Particulate Systems (ERC-SOPS), Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA.

M. Sebastian Escotet-Espinoza is a graduate research assistant at the Chemical and Biochemical Engineering Department at Rutgers, The State University of New Jersey,

Sharmista Chatterjee is acting branch I chief/division 1 of process assessment/Office of Process and Facilities, at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Thomas O’Connor is chemical engineer, science staff at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Sau Lee is acting associate director for science at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Maitraye Sen is a graduate research assistant at the Chemical and Biochemical Engineering Department at Rutgers, The State University of New Jersey.

In-silico design facilitates process optimization and evaluation of process control strategies.

Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment

Mark Mitchell is principal engineer at Pharmatech Associates.

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

Predicting Meaningful Process Performance

A. Morreale is manufacturing assistant at Laboratorio Farmaceutico SIT, Via Cavour, 70, 27035 Mede, Italy.

is manufacturing site manager, l.falce@sit-farmaceutici.com at Laboratorio Farmaceutico SIT, Via Cavour, 70, 27035 Mede, Italy.

C. Girani is regulatory affairs specialist at Laboratorio Farmaceutico SIT, Via Cavour, 70, 27035 Mede, Italy.

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.

Process Validation of Legacy Product

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Multivariate Data Analysis Finds Use In Biopharmaceutical Process Development And Scale-Up

Use of modeling software can help improve process understanding, and can be used in open- or closed-loop control.

Process and Scaling