Outsourcing

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Articles

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.

The Importance of Quality Agreements

Mike Jovanis is the vice president of product management at Sparta Systems

More life-sciences companies are starting to manage global suppliers holistically.

Getting, and Staying, Ahead of Global Quality Demands

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

FDA Guidance Helps Further Clarify Quality Agreements

David Deere is the chief commercialization officer for PaizaBio, a US-based contract manufacturing organization and consulting group with in-country aseptic fill-and-finish operations in Hangzhou, China. Deere is a veteran global pharmaceutical executive whose career path includes Valeant Pharmaceuticals International, F. Hoffman-La Roche and Genentech.

Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.

Regulatory Reform in China Creates Opportunities

Agnes Shanley is senior editor of Pharmaceutical Technology.

Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.

Offshore Supplier Quality: Trust, But Verify

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Reporting Quality Metrics to FDA

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.

Quality Metrics and Best Practices for Working with Contract Labs

Anthony M. Cundell is the director of microbiological development and statistics, Global Quality Technology, at Wyeth Pharmaceuticals, 401 N. Middletown Road, Pearl River, NY 10965-1299, tel. 845.602.2497, cundela@wyeth.com

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

FDA’s Guidance on Quality Metrics: Possible Implications for Contract Testing Laboratories

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Quality by Design in Contract Service Relationships

Michael Larson is a development associate in the Process Development Group at CMC Biologics, www.cmcbio.com.

Ashok Kumar is principal scientist in the Process Development Group at CMC Biologics, www.cmcbio.com.

James Schmid is a development associate in the Process Development Group at CMC Biologics, www.cmcbio.com.

Roland Ashton is a development associate in the Process Development Group at CMC Biologics, www.cmcbio.com.

Clinton Weber is associate director of BioProcess Sciences, in the Process Development Group at CMC Biologics, www.cmcbio.com.

Lisa Joslin is process validation manager, in the Process Development Group at CMC Biologics, www.cmcbio.com.

Traditional project decision-making is compared with a QbD approach.

Contract Services, Regulatory Consulting