Validation Articles

Part I of this article was published in Pharmaceutical Technology’s 25th Anniversary issue in July. Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry. Improving the future of computer validation infrastructure With the increased need to conduct computer validation, there comes a need to increase the efficiency of how computer validation is performed. To have better efficiency in computer validation practices, a better infrastructure for computer validation practices is required.

In Part I of this article, the authors address the regulatory,
business, and technological events and trends in computer
validation in the past 25 years. Current industry efforts and
the future of computer validation infrastructure will be discussed
in Part II.

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The validation of alternative microbiological methods for pharmaceutical testing is a very confusing topic, the more so as people use phrases such as “alternate sterility test” or “alternate microbial limits test.”What we have to agree to from the outset is that in fact we are not looking for “alternate” compendial tests.What most people actually mean is that we are looking for an alternative (and usually more rapid) means to determine whether a sample would meet the requirements of the compendial test. In most cases, the major components of the compendial test will be respected, it is only one or two particular aspects of the test that will be changed to increase the reliability or speed of the test. The sterility test by membrane filtration is an appropriate example.

Analysis of two years of FDA warning letters will tell you what is under the microscope.

The need to comply with regulatory requirements is a continuous process for companies under FDA oversight. The need to discover, produce, and market safe and effective products forces the industry to comply with regulatory requirements. The use of computerized systems and related governance processes are regulated by the Food, Drug, and Cosmetic Act,1 the Public Health Service Act,2 and other FDA regulations for overall conduct of R&D, manufacturing, and commercialization. Additionally, 21 CFR Part 11 specifically addresses the use of computerized systems in regulated industries.

 Table 1. FDA Warnings Related to Computerized Systems This article analyzes FDA warning letters concerning computerized systems from inspections conducted in 2003 and 2004 and discusses preventative and remediation techniques organizations can implement in preparation for agency inspections.3

Application of the ICH procedure to the validation of a chiral capillary electrophoresis method for the quantification of the major stereoisomeric impurity of galantamine hydrobromide drug substance is discussed. Because the reproducibility of capillary electrophoresis as an analytical technique is often questioned, special emphasis was put on the robustness evaluation. The method was found to be accurate, precise and adequately robust, and consequently able to be transferred with confidence to other quality-control laboratories for the successful performance of the procedure.

Introduction In the quality control of active pharmaceutical ingredients or drug substances, the validation of analytical procedures must be in compliance with the current guidelines set by regulatory authorities. The International Conference on Harmonization (ICH),1 has published a procedure for the worldwide concordance of analytical method validation.

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into theirn an industry with scant room for error, flawless validation systems are vital to successful manufacturing plants.

According to industry experts, however, companies vary greatly in both their awareness of the US Food and Drug Administration’(FDA)s current regulations on good manufacturing practices (CGMPs) and their ability to properly implement CGMPs into custom-tailored manufacturing systems.