Analytics

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.

Articles

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

Using the Bergum Method and the MS Excel software program, the author determines the probability of passing the USP dissolution test.

Using the Bergum Method and MS Excel to Determine The Probability of Passing the USP Dissolution Test

"The better we understand the relationship between process parameters and product attributes, the better control we'll have over product quality," said Beth Fowler, PhD, during Tuesday?s session on process monitoring at the AAPS Annual Meeting.

Improving Process Control and Analytical Methods for Bioprocesses

Participants in a 2003 PhRMA workshop present the industry’s current thinking on developing analytical method equivalency, including the importance of sample selection, acceptance criteria, data evaluation, and documentation.

Analytical Method Equivalency: An Acceptable Analytical Practice

The first part of this article introduced the basic features of Raman spectroscopy and presented some examples of its application in the pharmaceutical industry. This second part focusses on the technique's application as a PAT tool within the pharmaceutical manufacturing environment. FDA's PAT initiative has provided motivation to explore the application of 'new' analytical technologies to the pharmaceutical manufacturing process and Raman spectroscopy shows great promise. The strengths and weaknesses of the technique as a potential PAT tool are discussed together with some examples of how this works in practice in a pharmaceutical manufacturing environment.

Raman as a PAT Tool

Detection and identification of different polymorphic forms is, therefore, important throughout the drug development and manufacturing process.

Raman Spectroscopy for Pharma. Part 1: Principles and Applications

Cormac Smyth is a product manager and Breda O’Driscoll is managing director at Ultrasonic Scientific Ltd, 1 Richview Office Park, Clonskeagh, Dublin 14, Ireland. Tel. +353 1 218 0600 Fax +353 1 218 0601 info@ultrasonic-scientific.com www.ultrasonic-scientific.com

HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

Analysing Raw Materials and Formulations Using High Resolution Ultrasonic Spectroscopy

New Chemical Reaction Method Accelerates Indole Production

A newly developed software program transforms written SOPs for all required analytical method validation experiments into transferable automated templates, integrating individual activities and technologies under one platform.

Automating HPLC and GC Analytical Method Validation

The authors propose a strategy for classifying and validating inprocess testing methods.

Analytical Method Development