Microbial contamination of pharmaceuticals is variable in source and scope and may impact both the physical and chemical attributes of the product. The potential cost of contamination to the manufacturer can be in the billions of dollars. The potential cost of contamination to the patient is immeasurable.
Maintaining quality throughout the bioproduction workflow, from raw materials to distribution, is paramount to ensuring patient safety and requires a rigorous microbial control strategy. Implementation of a successful microbial control strategy begins with a trusted supply chain.
Due to the ubiquitous nature of microorganisms, microbial contamination is an inevitable issue that every manufacturer must face. Rapid and accurate detection and identification of contaminants allows faster response times to mitigate contamination and maintain product quality. Recent advances indicate a paradigm shift in industry and regulatory approaches in the use of rapid microbiology methods. Advances in technology and regulatory acceptance help ensure confidence in product quality and patient safety.