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Microbiology Guidelines

As pharmaceutical microbiology is crucial to the manufacture and production of drugs, biologics and devices, it is absolutely important that people working in these industries have a strong understanding and in depth knowledge of pharmaceutical microbiological principles, techniques, processes and strategies in order to avoid any potentially costly and life-threatening failures and consequences. Traditionally, in pharmacy and pharmaceutical sciences curricula, pharmaceutical microbiology is taught at various lengths and depths. Also, in many microbiology curricula, often pharmaceutical microbiology along with medical microbiology is taught. Pharmaceutical microbiology will continue to provide evidence-based and scientifically-proven approaches and procedures to ensure sterility, determine antimicrobial effectiveness, microbial contamination or bioburden, or to analyze endotoxins. With the emergence of ‘super bugs’ or ‘multiple drug resistant strains’ of pathogenic microorganisms, the role of pharmaceutical microbiology has become even more significant and relevant to quality healthcare provisions, and must be taught in great lengths, especially in healthcare and medicine related curricula world-wide.

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1.Microbiological Quality Considerations in Non-sterile Drug Manufacturing: Guidance for Industry

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