Analytics

Articles

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.

Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.

Validation of Alternative Microbiology Methods for Product Testing

Bernard A. Olsen, PhD, is a research fellow at Lilly Research Laboratories, Eli Lilly and company, 1650 Lilly Road, DC TL12, Lafayette, IN 47909, tel. 765.477.4923, olsen_bernard_a@lilly.com.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug Development

A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented.

Method Development of Swab Sampling for Cleaning Validation of a Residual Active Pharmaceutical Ingredient

This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.

Method Validation by Phase of Development: An Acceptable Analytical Practice

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

Use of the Bergum Method and MS Excel to Determine the Probability of Passing the USP Content Uniformity Test

FDA recently approved the first PAT applications for the introduction of rapid microbial testing of drug products and pharmaceutical-grade waters. Officials from FDA and GlaxoSmithKline worked together to ensure the appropriate scientific evaluation of the methods. Team members report on the successful validation approach and identify technical issues to be considered for the future.

The Introduction of Qualitative Rapid Microbiological Methods for Drug-Product Testing

Breda O’Driscoll is managing director at Ultrasonic Scientific Ltd

Sinead Hickey, Therese O’Reagan and Vitaly Buckin are at the department of chemistry, University College Dublin, Ireland.

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

Jayne Lawrence is at the department of pharmacy, King’s College London, UK.

This article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.

High-Resolution Ultrasonic Spectroscopy: Analysis of Microemulsions

The author describes a separation method for two active ingredients in the contraceptive pill with liquid chromatography UV detection.

An LC Method for the Separation and Determination of Ethynodiol Diacetate and Ethinyl Estradiol in Tablets

Jay Breaux, PhD, is senior director, Analytical Services at AAI International.

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products.

Analytical Method Development