Drug Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The Challenge of Finding the Unknown

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

Hikma Pharmaceuticals Warned About CGMP Violations at Portuguese Facility

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Parenterals, Particulates, and Quality by Design

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

Gerresheimer Introduces Integrated Processes for Mold Qualification

With a quality-by-design approach, robust processes can help deliver quality product consistently.

QbD Facilitates Robust API Development

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.

Diagnosing Facility Mold Infection

Meggle Group Wasserburg has been granted an EXCiPACT certificate.

Meggle Receives EXCiPACT Certification

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Using Quality by Design to Develop Robust Chromatographic Methods

With a quality-by-design approach, robust processes consistently can help deliver quality product.

QbD in API Manufacturing

FDA found violations of cGMP at finished-drug manufacturer in India.

Process and Scaling