by Mark Calmann
Outsourcing cGMP (current good manufacturing practice) contract testing services has become routine practice for many organizations in order to compensate for downsizing of internal resources. Outsourcing can drive cost savings, increase operational efficiency and leverage internal resources to focus on core competencies. In addition, with higher levels of regulatory scrutiny, the flexibility to outsource key testing services to a cGMP contract laboratory can save the organization investment monies needed to meet regulatory statutes.
To justify a decision to outsource, an accurate analysis by the organization's technical, quality and financial team is required. Presented below are six critical elements to evaluate a contract laboratory service for microbial identifications.
1. What is the focus of the library database for identifications, environmental monitoring or clinical diagnostic?
A contract laboratory must understand a company's business model and work with it as a strategic partner, not just a service provider. The laboratory must provide in-depth technical expertise and test methods designed to effectively and consistently give the most accurate species level identifications. This information is a critical regulatory requirement for tracking and trending events, managing risk and implementing appropriate corrective actions. The library database used for microbial identifications has the greatest impact on the accuracy, reproducibility and cost. Database libraries that are deficient will lead to errors in species level identifications or inconclusive results that will directly lead to higher costs due to additional testing needed. For superior service, the contract laboratory should perform under strict cGMP validation processes. It should incorporate frequent library updates to encompass taxonomic changes and the addition of novel organisms. Library species coverage should be reflective of the most frequently occurring organisms in a manufacturing environment. Libraries must go well beyond the in vitro diagnostic or clinical pathogens for the greatest ability to achieve a correct species-level identification.
2. Does the technology meet or exceed performance expectations?
Many technology platforms are available for microbial identifications: phenotypic systems that rely on biochemical reactions, mass spectrometry (MALDI-TOF) systems that analyze ribosomal protein spectra and DNA sequence-based systems. The goal is finding the right platform for microbiological identification that is accurate, robust, reliable and reasonably priced. Objectivity is required to analyze and interpret product claims against historical performance indices to determine the right outsourcing solution. In addition, some criteria to consider in a technology evaluation are: performance indices such as error rate, retest rates, accuracy, growth requirements, sample preparation methods, system limitations and time to first results.
3. Does the testing and documentation adhere to cGMP guidelines?
It's necessary to conduct an on-site vendor qualification to ensure the service provider has implemented a comprehensive quality management system. Auditors must ensure the service provider complies with and conforms to the regulations, that standard operating procedures are in place from sample receipt to report generation. The ability of the service provider to provide a summary report listing the organisms encountered at the facility and the frequency of occurrence is especially important for tracking and trending purposes. Manufacturers must demonstrate environmental control of their facility.
