Specification Compliance

It is therefore important for the pharmacist to advise on and provide alternative formulations of medications to facilitate patient compliance. Specifically ... 

Systems are also required to record whether or not all dispensed medication for a clinical trial can be accounted for at the end of the study. For each subject in the trial the amounts of dispensed medication are compared with the amounts consumed and the amounts returned. The remmed supplies are then destroyed and certified as such. The amounts dispensed may come from a pharmacy system and the percentage consumption within a dispensing interval could be derived as a measure of subject compliance. Specific points to consider during validation are therefore ... 

For approximate conversion from SI to traditional units (kPa to cmH O), divide lung compliance, specific compliance, and specific conductance by 10 and multiply airway resistance by 10 (1 kPa= 10.2 cmHp). 

If these limits are exceeded, the sources of error in the analysis should be determined, corrected, and all analyses subsequent to and including the last duplicate analysis confirmed to be within the compliance specifications should be repeated. 

A modular scanner system for NDE has been developed. It consists of a selection of individual electronics and motor module components, supported by scanner configuration and control software. The modules are used as standard building blocks for construction of job specific, dedicated scanners as well and general purpose scanners. The use of modular scanner components significantly reduce the work, time and cost not only for the design and manufacture but also for establishing documentation and ensure compliance with the relevant EU-directive requirements. 

Harmonised standards are technical specifications adopted by one of the European standards organisations following a mandate issued by the European Commission on which Member States were consulted. When published by the Commission in the Official Journal of the European Communities, the hamionised standards give presumption of confomiity to the essential requirements they specify. This means that manufacturers applying these standards do not have to demonstrate the compliance of the manufactured products with the relevant requirements of the directive. 

A section related to materials sets out, apart from general requirements, that compliance with the material specifications of the directive can be achieved in one of the following forms by using materials which comply to harmonised standards, by using materials covered by a European approval of materials, a subject which will be explained further on, and by a particular material appraisal carried out by the notified body. 

An important part of solving any differential equation is the specification of the boundary conditions. In the present case these can correspond to tension or shear and can be solved to give either a modulus or a compliance. 

In current industrial practice gas chromatographic analysis (glc) is used for quahty control. The impurities, mainly a small amount of water (by Kad-Fischer) and some organic trace constituents (by glc), are deterrnined quantitatively, and the balance to 100% is taken as the acetone content. Compliance to specified ranges of individual impurities can also be assured by this analysis. The gas chromatographic method is accurately correlated to any other tests specified for the assay of acetone in the product. Contract specification tests are performed on product to be shipped. Typical wet methods for the deterrnination of acetone are acidimetry (49), titration of the Hberated hydrochloric acid after treating the acetone with hydroxylamine hydrochloride and iodimetry (50), titrating the excess of iodine after treating the acetone with iodine and base (iodoform reaction). 

The adhesives are routinely tested for specific performance and compliance to many user specifications with different requirements. Government purchases are covered in the Mil Standard A-46050C (12). 

One of the greatest tasks in providing compendial standards is to obtain, adapt, or develop test methods for determining compliance with the standards. Such methods must be capable of routine use in many laboratories by different personnel and equipment. There is a vast difference between a method that can be used in one laboratory by speciaHsts and one that can be used in many laboratories by generaHsts to determine whether chemicals pass or fail the estabHshed specifications. Additionally, the deterrninations must be reHable, because the results obtained may determine whether a product is safe or legal. 

The objective of the FCC is to define food-grade chemicals in terms of the characteristics that estabUsh identity, strength, and quahty. It provides specifications in monograph form for some 900 food additives, together with analytical test procedures by which compliance with the specifications can be determined. The third edition was pubUshed in 1981 supplements followed in 1983, 1986, 1991, and 1993. The fourth edition is in preparation as of this writing and is to include monographs for almost 1000 food chemicals, including flavors. 

Specifications. Specifications for many of the essential oils and artificial flavorings are available (66). Physical specifications encourage standardization and uniformity in basic flavor and perfume materials. Although compliance with specifications does not guarantee that flavor quaUty standards will be acceptable, the specifications fill a need and provide a valuable reference for the flavor industry. 

The ADA maintains a Hst of certified dental materials and devices based upon the certification by the maker that the item complies with ADA specification and that the testing for specification compliance of the item is procured in Association laboratories. The ADA also maintains a Hst of classified dental materials and devices which prove to be acceptable or provisionally acceptable to the Association based upon data submitted by the apphcant and data available in the Hterature. 

Studies have shown that compliance with toothbmshing would be severely impaired if the bmshing regimen did not include dentifrices. Thus, the role of dentifrices in plaque control is to enhance the toothbmshing experience and thereby enhance the results. Dentifrices have tittle direct effect on plaque removal or accumulation unless they contain agents that have specific antiplaque properties. 

In the United States, federal regulations require automobile manufacturers to certify that vehicles are ia compliance with exhaust emission standards when tested under specific test procedures. 

Calibration Cahbration entails the adjustment of a measurement device so that the value from the measurement device agrees with the value from a standard. The International Standards Organization (ISO) has developed a number of standards specifically directed to cahbration of measurement devices. Furthermore, compliance with the ISO 9000 standards requires that the working standard used to cahbrate a measurement device must be traceable to an internationally recognized standard such as those maintained by the National Institute of Standards and Technology (NIST). 

The specific requirements to complete the NSR process will vaiy depending on the source location and characteristics, the federal and state regulations which apply, the compliance status of the facihty if it is existing, and the nature of other sources in the area. Atmospheric dispersion modehng is often necessary to determine the maximum offsite ambient air concentrations of the various pollutants that will be... 

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