Drug Development

Articles

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Our Readers Write In

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.

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing. 

The Simplified Akers–Agalloco Method for Aseptic Processing Risk Analysis

My audit host clearly knew and lied about the planned changes.

Water, Water Everywhere

I always suspected that our purchasing manager had agreed to this just to save money . . .

The Fine Print

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Better Process Understanding Improves Quality, Lowers Risk

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

Warning Letter: Pliva

Animal testing and accounting can both be hazardous.

Of Mice and Money

The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards. 

Effects of the 2006 Proposed Revisions to Annex 1 of the European Union Good Manufacturing Practices

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The need to curb drug counterfeiting is spurring development of track-and-trace and product authentication technologies.

FDA Revisits RFID and Drug Pedigrees

Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles. 

Process and Scaling