Microbiological Method Validation and Testing of Sterile and Nonsterile Pharmaceutical Products from Drug Development to Product Release and Post-Market Surveillance

 

Safety and efficacy are the two regulatory benchmarks for pharmaceutical products. Microbial contamination of products is an important aspect of product quality that can affect both safety and efficacy. The presence of microorganisms in sterile products or objectionable organisms in non-sterile products may impair safety of the products especially in vulnerable populations. Product efficacy may be impaired by microbial growth and byproducts leading to degradation of active components or other changes in formulations that may lessen product effectiveness. Suitable controls are built into materials and manufacturing practices to prevent or mitigate microbial contamination. Monitoring of materials and controls forms the basis of the Quality Control program to provide continued vigilance to assess the effectiveness of microbial controls. For non-sterile products, elements of microbial control should be built into the product during product development. For sterile products, the means of sterilization or aseptic processing form the basis of eliminating viable microorganisms to provide a suitable sterility assurance level. Product and process validation provide meaningful evidence of the ability to produce products that meet microbial specifications. Microbial testing is an adjunct that provides a point-in-time assessment of the product and process controls. Testing by itself cannot provide assurance but may alert the organization that controls are failing or have failed.

This presentation will consider the role of microbiology and microbial testing during product development, stability testing, process and product qualification, and commercialization. Microbial testing and testing strategies to assess pharmaceutical ingredients, in-process quality, and finished product microbial compliance with microbial specifications will be discussed

 

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