Aligning With the New Guidance: FDA Analytical Procedures and Method Validation

The recent FDA guidance document on analytical methods and validation is discussed. Key points in specific sections including Analytical Methods Development, Content of Analytical Procedures, Analytical Method Validation, Lifecycle Management of Analytical Procedures, and FDA Methods Verification are described. In order to assess company compliance with the new FDA guidance, a gap assessment tool should be created including guidance sections, requirements, remediation activity, and associated requirements. 

This content is only available to IVT members.
Get help maintaining your knowledge in Regulation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.

“Compliance Methods” is a reoccuring column in the Journal of GXP Compliance that discusses approaches, analytical methods, and techniques useful to practitioners in compliance and validation. “Compliance Methods” presents less common approaches or novel uses of well-known techniques. The purpose of this column is to provide information applicable to problem-solving situations, investigations, root cause analysis, and other applications.

4 Considerations for Using Six Sigma in Method Development and Validation

Six sigma is an improvement strategy for the manufacturing sector developed by Motorola in the 1980s. A process is considered at a six sigma level when there are 3.4 defects per million opportunities. When implemented correctly, it results in significant cost saving. Currently, six sigma techniques are shown to be successfully used in service functions as well as manufacturing.




At IVT's 11th Annual Method Development and Validation conference, Rafail Usatinsky discussed strategies for identifying, analyzing, and controlling different types of impurities in pharmaceutical products. Among these are genotoxic impurities, of which there are four different classifications. Usatinsky explained the threshold of toxicological concern and the alerting limits for genotoxic impurities.

Analytical Method Validation Volume III

The third edition in the series, Analytical Method Validation Volume III highlights application of method validation in the laboratory; implementation of process improvement strategies including QbD, PAT, LSS, DOE, and SPC; relevance of global method validation guidances and regulations; use of Monte Carlo Simulation; and validation of dissolution methods.

Table of Contents

Improvement Alphabet: Qbd, PAT, LSS, DOE, SPC—How do they Fit Together
Ronald D. Snee

Method Validation Studies: How GLP Interacts with Guidance Documents
Steven S. Kuwahara, Ph.D.

Reduction of Analytical Method Variability in an R&D Laboratory: A Case Study
Briank K. Nunnally, Andre Johnson, and Raymond Kaise

Method Validation (for Medical Devices)
Laure Larkin

Use of Monte Carlo Simulation to Address CMC Issues
Harry Yang, Ph.D.

Validation of Dissolution Methods
Gregory P. Martin and Vivian Gray

USP <1010> Analytical Data-Interpretaion and Treatment Appendix E: Comparison of Methods
Lynn Torbeck

Addressing Compliance Concerns During Dissolution Method Development, Validation, and Transfer
Gregory P. Martin and Vivian Gray

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Method Development. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Pharm Tech's Analytical and Bioanalytical Testing

Analytical methods development are crucial for ensuring product quality of pharmaceuticals. This supplement offers case-study analysis of the chromatographic, spectroscopic, and imaging methods used in the identification, characterization, and quantification of drug substances and drug products as well as impurity analysis.

Download the Analytical and Bioanalytical Testing e-book.




Using Bergum's New Method and MS Excel to Determine the Probability of Passing the New ICH USP 29 Content Uniformity Test

Download "Peer Reviewed: Using Bergum's New Method and MS Excel to Determine the Probability of Passing the New ICH USP 29 Content Uniformity Test"

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Method Development. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Analytical Method Validation Volume II

A second volume in IVT's special edition series on Method Validation, this special edition seeks to solidfy and enhance the concepts from the previous special edition Analytical Method ValidationThis special edition discusses analytical methods, appropiate documentation, FDA expectations, stability testing, and much more!

A Step-by-Step Approach to Establishing a Method Validation Program
Cindy Green

Biological Method Validation A Practical Approach
Cindy Green

Defining a Master Plan for the Validation of Analytical Methods
Paul A. Winslow, Ph.D. and Richard F. Meyer, Ph.D.

FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry
Jerry Lanese, Ph.D.

Guidance for Industry Bioanalytical Methods Validation for Human Studies
US Food and Drug Adminstration

Suitability of Analytical Methods for Stability Testing – Is There Room for Improvement?
David R. Rudd

Validation of Analytical Methodology: A Detailed Look at How to Assure the Quality of Your Data
Harry G. Brittain, Ph.D.

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Method Development. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Analytical Method Validation

A collection of some of the Journal of Validation Technology and the Journal of GXP Compliance's most informative articles, this special edition is designed for those who manage or execute the validation of analytical methods for the quality control of small and large molecule pharmaceuticals, bio/pharmaceuticals, and biologics.

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Method Development. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.