Abstract
The role of the microbiologist during product development of medicines ensures patient safety during clinical trials and also the continuation of microbial control through the commercialization of the new product. Microbiological expertise, insight, and cGMP input for new product development is needed for formulation, manufacturing, packaging, and monitoring, plus testing of in-process materials and the finished dosage form as well as stability. Risk assessment and evaluation of potential microbial contamination origin(s) support a phase-appropriate, broad end-to-end analytical approach to microbiological contamination control strategy. The ultimate beneficiary of this robust oversight and management of quality is the patient. Using knowledge and risk assessment along with experience (of nonsterile and sterile drug product development) provide for a balanced approach to microbiological quality in medicines. This paper will discuss more specific area detail to consider for the role of a microbiologist in nonsterile drug product development.
- Pharmaceutical development
- Microbial contamination
- Risk assessment
- Pharmaceutical ingredients
- Formulation
- Microbial specification
- Preservative effectiveness
- Water activity
- pH
- Manufacturing process
- Regulatory filings
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In This Issue
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- Article
- Abstract
- Introduction
- Pharmaceutical Ingredients—Actives and Excipients
- Water Activity of Nonsterile Dosage Forms
- Antimicrobial Preservative Effectiveness Testing
- Manufacturing Process
- Bioburden of Nonsterile Drug Products
- Emerging New Dosage Forms
- Qualification of Microbial Test Methods
- Microbial Testing as a Stability Test Parameter
- Package Integrity Testing
- Risk Assessment
- Regulatory Contributions
- Conclusions
- References
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