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Contents

  1. East West University Library catalog › Details for: Handbook of microbiological quality control :
  2. 1st Edition
  3. 1st Edition
  4. Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices
  5. The Importance of Microbiological Quality Control in the Pharmaceutical Industry

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Comparison of viable plate count, turbidity measurement and real-time PCR for quantification of Porphyromonas gingivalis. See DOI: Effect of contaminated expired and unexpired penicillin g injection on the haematological indices of juvenile wistar rats Iquo Asu Takon , Sylvester P. Design and evaluation of a novel passive bioaerosol sampler Jennifer Therkorn.

Often, new methods rely on a completely different body of information, some may be direct measurements, some indirect. In either event, previous acceptance criteria may not be applicable. Therefore, implementation of newly developed, or more rapid, microbiology methods may also require establishment of new acceptance criteria. In an ideal world, when a method is translated to the field, all experimental variables are understood and laboratory data are faithfully produced.

In microbiology, this ideal is not always achieved, especially in environmental studies where the microbial population changes regularly. This does not mean that a method is inappropriate for a certain set of samples.


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In this sense it is important to re-emphasize that microbiological methods are based on secondary or artifact systems: dye uptake, ATP formation, or cell division in specific conditions. Every method, new or old, will have situations that work well and situations that do not. The user needs to be familiar enough with the weakness of the test to understand its limits of use. Too many laboratories use conventional methods and base important decisions on insignificant data.

This is particularly evident when methods such as plate counts, producing less than 10 colonies, are used as acceptance or rejection criteria. Even worse are the methods for monitoring cleanrooms that employ acceptance criteria that are below plausible quantitative ranges. Prince and Prince [21] point out that data from air, water, surfaces, and personnel must show changes that are measurable and reproducible if process control improvement is the goal.

If the change cannot be measured, then change-related improvement cannot be demonstrated.

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New methods are needed to provide meaningful measures of process control improvement in this situation [26]. Development of any new method should generate sufficient data in support of its suitability for use.

East West University Library catalog › Details for: Handbook of microbiological quality control :

During development of rapid sterility testing methods for cell-based products, comparative studies have shown that some methods detect different species with different frequencies [27]. This is expected, just as the compendial sterility tests do not detect all species. The development and implementation of any new method requires an assessment of the incidence of false positives and false negatives. When implementing new methods, procedures must be established to recognize the impact such methods have on the data, and to provide actions for investigation and correction of deviations.

For counting methods, the correct action may be to change the acceptance criteria based on risk analysis. FDA is currently training its regulators to understand the limits of tests and the value of their data, using a risk-based approach. FDA regulators will work with manufacturers as data reveal hitherto unforeseen challenges to the analysis and interpretation of existing and new quality control tests. In summary, although microbiology tests represent only a small portion of a pharmaceutical quality testing program, their importance is critical to product safety.

1st Edition

It is therefore incumbent upon the quality unit, both QA and QC, to understand the strengths and weaknesses of conventional, recent, and emerging microbiology technologies. New microbiology methods can offer advantages of speed and precision for solving microbiological problems associated with materials or environmental influences. Neither Corporate economics nor regulatory attitudes should be a barrier to the use of new testing technologies or different measurement parameters.

In fact, if we are to increase our understanding of quality-based products and processes, then quality by design principles and risk analysis methods must be extended to the development of new microbiological technologies. This approach will drive process engineering to yield real, measurable gains in microbiological product quality assurance.

MacLeod, N. Chappelle, and A. Conn, R. Charache, and E. Ukuku, D. Pilizota, and G. Food Protect.

1st Edition

Cross-Smiecinski, A. In: Manual of Environmental Microbiology, ed.

Taylor, J. Food and Drug Administration. Cundell, A. Postgate, J.

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Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

In: Methods in Microbiology, Vol. Norris, and D. Academic Press, New York. Pelczar, M.


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  • Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices / Edition 1.

McGraw Hill, New York. Daley, R. Hobbie, J. Daley, and S. Hussong, D. Colwell, M.

The Importance of Microbiological Quality Control in the Pharmaceutical Industry

Pearson, R. Weiner, and W. Culture Media. Enumeration of Micro-organisms. Identification of Micro-organisms. Specified Organisms. Rapid Methods. Sterility Assurance. Endotoxin Testing. Preservative Efficacy Testing. Microbiological Assay. Disinfection and Cleansing. Microbiological Audit. Case Studies and Calculations.

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