Quality control protocol development

Boomer and Powell [242] have developed an analytical technique using inductively coupled plasma mass spectrometry to estimate the concentration of uranium in a variety of environmental samples including soil. The lower limit for quantitation is 0.1 ng/ml. Calibration is linear from the low limit to 100 ng/ml. Precision, accuracy and a quality control protocol were established. Results are compared with those obtained by the conventional fluorometric method. 

EPA sampled in the locations most likely to be contaminated with dioxin (i.e., loading, storage, or production areas). If offsite migration of contaminated material was suspected, EPA sampled outside the facility boundary. Quality assurance/quality control protocols, following Superfund-authorized procedures, were developed to ensure that all data generated would be of known quality. 

A validation programme should be co-ordinated by a multidisciplinary committee comprised of the different functions that are involved in the programme. Typically, the members of the validation committee would be drawn from departments such as production, quality assurance, microbiological and analytical quality control, pharmaceutical development, engineering, and maintenance. The committee approves and issues written protocols, and reviews the data obtained in order to approve or reject the programme results. 

Solid fat content (SFC) analysis is probably the most used LR-NMR application in the food industry. The initial success of the method prompted Unilever (manufacturer of margarines and related products) and Bruker (manufacturer of NMR instruments) to start a joint venture with the goal of building a table-top LR-NMR spectrometer for solid-to-liquid ratio analysis in the fat industry. The method was developed in the early 1970s and over the years leaded to various quality control protocols for fat and oils that are by now adopted as official methods by various international and national organizations. The success story of SFC analysis opened wide the door for LR NMR methods to penetrate as routine techniques in the food industry. 

HTS accelerates the identification of drug leads through the analysis of enormous numbers of samples in a series of automated assays (primary assays) run repetitively by robots. To decide whether to accept or reject the assay results, scientists validate the assay, analyze the data collected, and monitor whether the assay runs according to protocol. Several quality control procedures have been developed to evaluate the screening results and to... 

No adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine. Therefore preclinical and toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/ vaccine combination [60], Evaluation in preclinical studies is important for identifying the optimum composition and formulation process and also for allowing development of tests for quality control [61]. Data from these studies also helps plan protocols for subsequent clinical trials from which safety and efficacy in humans can be evaluated. 

The pharmacist must also take an active role in the development, implementation, and review of an organization s policies, procedures, and protocols. The pharmacist should ensure that all aspects of care are addressed, including patient care, drug preparation and dispensing, quality control, infection control, and equipment maintenance. Involvement in such activities can have far-reaching effects on efficiency and financial outcomes. 

The results obtained within the SWIFT-WFD project, dealing with the preparation of water reference materials, will contribute to the future developments of such materials, especially for the analysis of pesticides and PAHs at low concentration levels. The two different strategies employed, direct fortification in the laboratory by using spiking solutions following detailed protocols, and fortification of the material before dispatch, led to homogeneous and satisfactory stable reference materials for quality control purposes. 

The primary outcomes of this CRP are the development and quality control of Lu-DOTATATE for PRRT of neuroendocrine tumours and the establishment of a protocol that can be used for its preparation for clinical application. Details concerning this development and descriptions of the optimal protocols for preparation and quality control of this agent are provided in the reports included in Part 11 of this publication. 

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