« RMM
Next, a discussion on enhancing the technical, quality and business aspects of manufacturing and quality assurance is provided. Here, TR33 describes increases in process and product knowledge, continuous improvement, automation, and return on investment when implementing rapid and alternative methods.
An evaluation of risk when using an alternative or rapid method, as well as the risk to product quality when implementing such methods, is the topic of the next section. Guidance on the identification of potential risks or hazards, severity, occurrence and the ability to detect these risks are discussed. Risk analysis tools and other resources are also provided.
The next section focuses on technology suppliers. TR33 provides recommendations for what end-users should consider prior to purchasing instrumentation and after a method is put in place. This includes a supplier’s quality systems, field support, assistance with validation and financial stability. Guidance on conducting supplier audits and assessments is also afforded.
A brief review of automated systems is then discussed. Methods that are considered an extension of compendial or classical methods (e.g., a growth-based system that produces colony forming units) may realize reduced validation requirements.
The next series of sections provide an overview of the scientific principles for alternative and rapid systems that are currently available
or are in development, and these are identified in Table 2. Technologies that detect, enumerate and identify microorganisms are described; however, supplier and technology names are excluded to avoid bias. Fortunately, TR33 provides references both in print and online (such as the RMM educational website,
http://rapidmicromethods.com) that describe commercially available systems.
The second half of TR33 concentrates on validation and implementation. The validation section first describes the use of feasibility or proof-of- concept testing when initially identifying systems/methods that may be compatible with a firm’s intended test samples or products. TR33 then provides recommended responsibilities for both the end-user and the technology supplier. Overviews of the User Requirements Specification, Design Qualification, Functional Design Specification, Requirements Traceability Matrix, SOPs and technology training, system integration, and Installation (IQ), Operational (OQ) and Performance (PQ) Qualification strategies follow. Approaches for on-going maintenance and periodic reviews (e.g., preventive maintenance, calibration and software updates) are also examined. It is of interest to note that TR33 now describes a two-phased approach to validating the entire system that includes verification of the equipment and software, followed by validation of the analytical method. The majority of the computer system validation will usually occur during the OQ, with the PQ covering both method validation and method suitability (see below).
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