Topic

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

Articles

Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.

Harmonization of Batch Records

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

New therapies and tighter budgets challenge bio/pharma to think outside the industry.

When One Therapy No Longer Fits All

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

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

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing.  The authors included a brief summary of the comments developed on the draft document.  This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft. 

Annex 1 Misses the Mark–Expanded Version

FDA enforcement efforts and drug approvals trend upward. 

Regulatory Role in Pharma Progress

Hospitals form not-for-profit drug company to combat drug shortages and high prices. 

A New Business Model for Pharma?

The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation. 

Annex 1 Misses the Mark

Bio/pharma professionals manage expectations amid industry uncertainty.

New Year, New Questions

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

What’s in Your SOP?

Is pharma up to the task of developing knowledgeable, motivated employees?

Wanted: A Highly Skilled Bio/Pharma Workforce

Industry experts were honored for business, scientific, and social contributions.

Viewpoints