The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the ‘assess and release’ process of pharmaceutical products. However, there is an ever-increasing number of technologies available on the market that have benefits in addition to faster time-to-result, such as standardization and automation of readout and improved data integrity.
Regulators have been encouraging the pharmaceutical industry to adopt these innovative systems. Yet it has taken a considerable time before receiving the first approvals from various health authorities (including both EMA and FDA) for using an alternative and rapid sterility test to release sterile drug product lots.This paper describes a systematic nine-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests. This can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests.
To take advantage of the numerous benefits of alternative sterility tests, the following nine steps are recommended:
1: Identify operational/business need
2: Define the application
3: Assess requirements
4: Compare options and technologies: landscaping and candidate(s) selection
5: Develop a business case: technical, quality, and business evaluation and justification
6: Perform proof-of-concept studies/feasibility studies/pre-validation studies
7: Validate at pilot or primary site
8: Deploy global/company-wide qualification of additional laboratories
9: Define regulatory filings and implementation strategy.
Published in the PDA Journal of Pharmaceutical Science and Technology, it contains two case studies illustrating the validation and implementation approach, including statistical methods. Both case studies show the successful implementation of an alternative sterility test for sterile drug products with an ~50% reduced incubation time.