Risk assessment data quality requirements

The considerable lack of experimental data for the fate and effects assessment of environmental contaminants requires the provisional use of substitutes. For this purpose, QSAR estimates are superior to the alternative of using uniform default values, which do not allow differentiation and ranking of the potential hazards of diverse chemicals. QSAR data-quality requirements for assessing environmental hazards and risks have to be evaluated relative to the quality of the available experimental data and the relevance of the accuracy of the individual data for subsequent hazard and risk classifications. Within these assessment schemes, several factors are usually ignored for the sake of scientific precision and standardization. The simplifications of the real world apply, regardless of whether experimental or calculated input data are used ... 

The concept of risk assessment requires a profound understanding of food dynamics and technological conditions that may impact the risk levels of certain hazardous compounds. It requires that scientific information and data are collected to underpin conclusions about risk levels. Risk assessment can be used to scientifically underpin the selection of hazards that must be covered by a quality or safety assurance system (e.g., HACCP) that will improve the reliability of the system. 

Description of process/environment Quality-related critical parameters Purpose and objectives of the system Major benefits of the system Special requirements Specific training needs System operating strategy Related GMP compliance/regulations Physical and logical boundaries System GMP risk assessment System validation rationale Life-cycle documentation Assumptions and prerequisites Limitations and exclusions Quality-related critical parameters/data Standard operating procedures System requirement specification Supplier and system history... 

The 1996 Food Quality Protection Act (FQPA) now requires that an additional safety factor of 10 be used in the risk assessment of pesticides to ensure the safety of infants and children, unless the EPA can show that an adequate margin of safety is assured with out it (Scheuplein, 2000). The rational behind this additional safety factor is that infants and children have different dietary consumption patterns than adults and infants, and children are more susceptible to toxicants than adults. We do know from pharmacokinetics studies with various human pharmaceuticals that drug elimination is slower in infants up to 6 months of age than in adults, and therefore the potential exists for greater tissue concentrations and vulnerability for neonatal and postnatal effects. Based on these observations, the US EPA supports a default safety factor greater or less than 10, which may be used on the basis of reliable data. However, there are few scientific data from humans or animals that permit comparisons of sensitivities of children and adults, but there are some examples, such as lead, where children are the more sensitive population. It some cases qualitative differences in age-related susceptibility are small beyond 6 months of age, and quantitative differences in toxicity between children and adults can sometimes be less than a factor of 2 or 3. 

One of the main concerns of any environmental project is the collection of relevant and valid data. These are the data of the type, quantity, and quality that are appropriate and sufficient for the project decisions. The standards for data relevancy and validity stem from the intended use of the data since different uses require different type, quantity, and quality of data. For example, the data requirements for a risk assessment project are drastically different from those of a waste disposal project the requirements for site investigation data are different from these for site closure. 

Exposure estimates that are required for risk assessment may be obtained from chemical-specific field studies, or from extrapolations from other field studies. This requires high-quality exposure data that have been obtained under conditions relevant for the exposure and use scenarios under consideration (Krieger et al, 1992 Eenske and Teschke, 1995 Krieger, 1995 Turnbull et al, 1995). For risk assessment purposes, the exposure data obtained for relevant use scenarios can be compared with an appropriate accepted exposure level (e.g. Acceptable Operator Exposure Level (AOEL)) based on the toxicological profile of the compound. 

There are many places dnring a validation project where it is appropriate to nse risk assessment as a basis for key decisions. This case stndy will follow a hypothetical implementation of an integrated chromatography data system (CDS) in a Quality Control laboratory (see Figure 29.1). In accordance with the documented user requirements, this system will ... 

Electronic records requiring particular regulatory control should be identified based on critical process control points and associated critical parameters that directly impact product quality or product safety. A defined process should be used to conduct this analysis, and it should be one that builds on or is complementary to any assessment conducted as part of product registration. Consistency is key. There may be additional records identified by predicate rules but care must be taken not to extend beyond these records. A risk assessment should be conducted to determine appropriate electroific record management controls such as audit trail and archiving. Electronic records will need to be archived for retention periods specified in predicate rules. Other data related to process performance rather than product quality or product safety requires only basic data maintenance and may be retained for much shorter periods before being purged. 

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