Quality Protocol

We will also review the development of chemical metrology in the pharmaceutical industry, an industry that is ever more closely related to molecular biology. The pharmacists first developed quality protocols and reference materials more than 40 years ago, quite independently of the activities of ISO and the REMCO Technical Committee. Only in the closing years of the 20th Century have these two important groups begun to realize that they share common objectives. 

ECHA points out that some materials currently considered as waste might in future be considered to have ceased to be waste [15]. These materials will then be out of the scope of waste legislation, and - if not covered by an exemption - will potentially fall under REACH. Clarification of end-of-waste criteria is a matter for waste legislation. In accordance with the general principle of subsidiarity of the European Union law, and following the revised Waste Framework Directive, Member States may decide case by case whether certain waste has ceased to be waste, where end-of-waste criteria have not been set at Community level. Member States have already worked for use of this regulation, like, e.g., the Waste Quality Protocol in England, Wales, and Northern Ireland [16]. 

Verma SR (2008) Developing a standard and quality protocol for anaerobic digestion. ECN/ ORBIT Workshop, Niirnberg... 

Studies undertaken by LGC during the VAM 1994-1997 programme have demonstrated that a large number of generic problems need to be addressed before the potential power of nucleic-add-based methods can be reliably applied. The main outputs of the DNA technology validation project in the new programme will be validated novel measurement systems which utilise DNA technological procedures, quality protocols, and reference materials. 

The study design is an important element in assessment of quality protocols. The overall purpose of the study design is to reduce the variability or bias inherent in all research. Good study design will always address control methods that reduce experimental bias. These control methods will often include treatment blinding, randomization and between- or within-patient study designs. The Schedule of Assessments describes a schedule of time and events and provides a complete... 

The inclusion and exclusion criteria are described in the Subject Selection part of the protocol. To a large extent, the success or failure of a particular clinical trial can often be traced back to how well these criteria were developed. Good protocol authors strive to include the most appropriate patient population to satisfy the study objective and still include those kinds of patients who will ultimately receive the drug. Therefore, selection criteria can be unreasonable and unnecessary in some cases and vague and not specific in other cases. The management of concomitant medications is particularly problematic. The protocol must attempt to define those medications that are permitted for intercurrent illnesses and those that are prohibited as they will interfere with the interpretation of the test medication. Although there are no easy answers, quality protocols are able to justify with some precision the rationale for each inclusion and criteria. How these criteria are applied is handled in the Screening for Study Entry section. 

French standard, 1999. XPT 90-210. Water quality - protocol for the evaluation of an alternative quantitative physico-chemical analysis method against a reference method. 

French Standard, 2003. XPT 90-220 water quality - protocol for the estimation of the uncertainty associated with a result for a physico-chemical analysis method. 

To assist in the marketing of tyre-derived rubber products, a categorisation system has been established as part of the UK Waste Resources Action Programme (WRAP) Quality Protocol (Section 6.4.1.5), which will help avoid possible confusion in the use of terms such as rubber crumb and rubber powder . The categories and definitions that are in the protocol are shown in Table 6.1. 

The reason why the Quality Protocol has been published is related the EU Waste Framework Directive (2006/12/EC) and the importance of defining at what point rubber waste has been fully recovered and ceases to be waste as it is defined in Article l(l)a of this Directive. Hence, this is also the point at which the Directive no longer applies and so it can be used without the need for waste management controls. It was perceived that problems in defining this point had inhibited the development and marketing of materials produced from waste rubber. 

To comply with the Quality Protocol the tyre-derived rubber materials must be destined for use in one if the designated applications within certain designated market sectors ... 

Figure 6.7 Main stages and control mechanisms of the Quality Protocol. Reproduced with permission from the WRAP Quality Protocol, Waste and Resources Action Programme, Banbury, UK, p.7. WRAP...

The Quality Protocol also provides information in a number of other areas that are relevant to tyre-derived rubber materials, such as the good practice guidelines shown in Sections 6.4.1.3 to 6.4.1.5, and these are present in Appendices in the Protocol. 

Good practices for the storage of rubber crumb and tyre-derived materials should be followed, both on site and at an interim location, and these can be found in Annex B of PAS 107 2007 (Publically Available Specification prepared by the BSI). Additional good practice guidance was provided in the WRAP Quality Protocol described above. 

Good Practice for Unbound Applications of Tyre-derived Rubber Materials in Sensitive Environments - UK WRAP Quality Protocol... 

With regard to the manufacture of crumb using ambient grinding-type processes, the BSI has published a PAS for the collection, initial storage, production and final storage of size-reduced, tyre-derived rubber materials. It is designated PAS 107 2007. This document has already been referred to in Section 6.4.1 in connection with quality protocols that apply to rubber crumb. 

The use of cryogenic grinding and water jet processes for the manufacture of crumb is not currently included in any PAS, but PAS 107 2007 can be used for these types of processes when manufacturers want their crumb to be considered as having been manufactured according to the Quality Protocol published by WRAP (see Section 6.4.1). The only part of PAS 107 2007 that does not need... 

They have been produced using only those input materials specified in Section 2 of the UK Waste Resources Action Programme (WRAP) Quality Protocol [1] (i.e., source segregated waste tyres). 

Tyre-derived rubber materials meeting the UK WRAP Quality Protocol in the UK may cease to be waste in England and Wales, but the country of destination may take a different view and, under the Waste Shipment Regulation, if the competent authority in that country considers the material to be waste then the controls specified in EU Regulation EC/1013/2006 will apply to the shipment. 

WRAP Quality Protocol for Tyre-derived Rubber Material, November, 2009, WRAP, UK. http WWW. wrap. org. ukJ... 

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