Methods in validating tests

Each of these considerations are discussed in greater detail below.From a scientific perspective, it is important to understand what technical capabilities are required, including, but not limited to, method sensitivity and specificity (e.g., detection levels and for what types of microorganisms), sample throughput, sample type, automation, data handling and archiving, report management, if the system needs to meet 21 CFR Part 11 expectations, and the required degree of operator training.In summary, the initial assessment of a RMM should include a comprehensive scientific, regulatory and business due diligence review, in addition to matching the appropriate technology with the desired microbiology application.It is not uncommon for companies that have purchased a RMM system to spend considerable time, resources, and expense in validating the instrumentation and method, only to find at a later date that the technology is incompatible with the process and/or product being evaluated, or that the sensitivity and/or specificity of the system is not what was originally anticipated.This can be accomplished using a rental or loaner instrument, or by sending samples directly to the RMM instrument supplier for evaluation.The data obtained from these initial studies will help with the decision to purchase the RMM and proceed with formal validation activities.The ICH Q9 guideline, Quality Risk Management, defines QRM as a systematic process for the assessment, control, communication and review of risk to the quality of drug product across the product lifecycle.

This can be accomplished through a formal audit or supplier questionnaire.Next, proof-of-concept or feasibility testing can be performed to determine if incompatibilities exist between the RMM and the intended product or test sample(s).These types of studies can also be performed in the event the RMM supplier has little or no data on testing similar product or test materials.Tools such as Failure Modes and Effects Analysis (FMEA) or Hazard Analysis and Critical Control Points (HACCP) may be utilized in assessing the potential risks when implementing the RMM.A validation plan should be followed which will provide the roadmap for all of the activities that will be required to demonstrate that the RMM is validated and suitable for its intended use.

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The due diligence process also involves a review of existing regulatory commitments and whether implementing the RMM will result in significant changes that will require a formal submission to relevant regulatory bodies.

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