Monitoring protocols practicality

Control of long-term overheating requires modifying water chemistry and a close analytical monitoring protocol to minimize or eliminate the risks of deposits. In many cases, some significant change in boiler operating practices is also required. 

An automated process is a series of repeated, identical operations under the control of a master operation or program. While simple in concept, it is complex in practice and difficult in implementation and execution. The process control operation must be designed in a logical, step-by-step manner that will provide the desired outcome each time the process is cycled. The sequential order of operations must be set so that the outcome of any one step does not prevent or interfere with the successful outcome of any other step in the process. In addition, the physical parameters of the desired outcome must be established and made sulgect to a monitoring protocol that can then act to correct any variation in the outcome of the process. 

S. A. Osofansky, A practical anesthesia monitoring protocol for free-ranging adult African elephants (Loxodonta africana), J. Wildl. Dis., 1997, 33, 72-77. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

In this way, the operational range of the Kolbe-Schmitt synthesis using resorcinol with water as solvent to give 2,4-dihydroxy benzoic acid was extended by about 120°C to 220°C, as compared to a standard batch protocol under reflux conditions (100°C) [18], The yields were at best close to 40% (160°C 40 bar 500 ml h 56 s) at full conversion, which approaches good practice in a laboratory-scale flask. Compared to the latter, the 120°C-higher microreactor operation results in a 130-fold decrease in reaction time and a 440-fold increase in space-time yield. The use of still higher temperatures, however, is limited by the increasing decarboxylation of the product, which was monitored at various residence times (t). 

Monitoring programs must have their own quality assurance programs. These may be called project quality assurance plans or protocols for specific purposes O). If reliable vendors of services are used, the bulk of the quality assurance effort can be placed on those activities unique to the program. Without reliable vendors, QA efforts will be ineffective since it is not cost effective to police quality assurance practices at all lower levels nor to screen all data for its validity. 

In Chapter 9, lecturers V. Ortun Rubio of Pompeu Fabra University and L. Cabiedes Miragaya of the University of Oviedo address the subject of measures intended as a way of influencing prescriber decisions. The authors place special emphasis on analysing prescriber incentive policies, distinguishing between incentives of a financial nature (both coercive and non-coercive) and non-financial incentives (information, training, treatment protocols, monitoring of prescription practices, cost-effectiveness guidelines, interaction with other professionals, pressure from patients and so on). The authors advocate incentive policies based on a combination of financial and non-financial incentives. 

The concept of a control is a device or mechanism to detect variations in the monitored procedure that are significant enough to produce a detectable result. In the case of IHC stains, the inability of subjective visual assessment to detect significant stain results has obscured this major source of variation for most users. This author has worked with quantitative evaluations of his-tochemical stains for many years. Initial attempts at quantitative evaluation of IHC stains clearly indicated that current practice does not provide adequate control of IHC stain protocols. 

The ability to provide accurate and reliable data is central to the role of analytical chemists, not only in areas like the development and manufacture of drugs, food control or drinking water analysis, but also in the field of environmental chemistry, where there is an increasing need for certified laboratories (ISO 9000 standards). The quality of analytical data is a key factor in successfully identifying and monitoring contamination of environmental compartments. In this context, a large collection of methods applied to the routine analysis of prime environmental pollutants has been developed and validated, and adapted in nationally or internationally harmonised protocols (DIN, EPA). Information on method performance generally provides data on specificity, accuracy, precision (repeatability and reproducibility), limit of detection, sensitivity, applicability and practicability, as appropriate. 

Results on the refinement of protocols for sampling analysis are forthcoming in the report on the EPA/NBS workshop on monitoring. Additional work on statistical design is also in progress to find practical ways to reduce required sample size which in turn leads to reductions in cost and more efficiency in dealing with contractor release after abatement. 

The assignment of the patient to a par- (h) ticular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to (i) the patients and epidemiological methods shall be used for the analysis of collected data ... 

Gonadotropins are used to treat infertility in women with potentially functional ovaries who have not responded to other treatments. The therapy is designed to simulate the normal menstrual cycle as far as is practical. A common protocol is daily injections of menotropins for 9 to 12 days, until estradiol levels are equal to that in a normal woman, followed by a single dose of hCG to induce ovulation. Two problems with this treatment are risks of ovarian hyperstimulation and of multiple births. Ovarian hyperstimulation is characterized by sudden ovarian enlargement associated with an increase in vascular permeability and rapid accumulation of fluid in peritoneal, pleural, and pericardial cavities. To prevent such occurrences, ovarian development is monitored during treatment by ultrasound techniques and by measurements of serum levels of estradiol. 

Documentation is critical for assessment. Standard protocols provide directions for what must be documented and how the documentation is to be done, including how to record information in notebooks. For labs that rely on manuals of standard practices, it is imperative that tasks done to comply with the manuals be monitored and recorded. Control charts (Box 5-1) can be used to monitor performance on blanks, calibration checks, and spiked samples to see if results are stable over time or to compare the work of different employees. Control charts can also monitor sensitivity or selectivity, especially if a laboratory encounters a wide variety of matrixes. 

Because impurities most often result in reduced crystal growth rate, feedstocks to laboratory and bench-scale units should be as similar as possible to that expected in the full-scale unit. The generation of impurities in upstream process units can depend on the way those units are operated, and protocols of such units should follow a consistent practice. It is equally important to monitor the composition of recycle streams so as to detect any accumulation of impurities that might lead to a reduction in growth rates. 

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