Common technical specifications

Common technical specifications (CTS) are to be adopted by the Article 7.2 Committee (a working group of scientific experts appointed by the Member States) which will apply to devices in Annex II List A and, when required, devices in Annex II List B. There is some uncertainty about the circumstances in which the requirement might apply to List B devices. CTS establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods, and reference materials. If, for duly justified reasons, manufacturers do not comply with the CTS, they must adopt other solutions which are at least equivalent to these specifications. CTS are intended mainly for the evaluation of the safety of the blood supply and organ donations. 

Some internationally harmonized guidelines regarding specifications and tests, impurities and validation of analytical methods have particular relevance to the development of chiral drugs and are discussed below. In addition, the impact of work on the common technical document is considered. 

Electronic Common Technical Document (eCTD) specifications. www.ich.org... 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

The application should be in the format of common technical document (CTD), which became mandatory from July 2003. The regional specific requirements are in the Modules 1 and 5 of CTD, which are described below. 

The common technical document (CTD) is a method of submitting an NDA. It is a very useful outcome of ICH discussions regarding the creation and implementation of standardized document formats. While individual regulatory agencies still have different requirements of specific content of various documents, this standardized format is a considerable step forward in the harmonization of submissions to multiple agencies. This guideline, adopted by the ICH regions (Europe, Japan, and the United States) in 2000, has subsequently been implemented, and other countries may continue to adopt it. 

Although there are different methods of procurement, they all involve a niunber of common activities that must take place beforehand. These activities are the establishment of technical specifications, quantification of requirements, issuing of some form of tender, and selection of product(s) and manufacturer(s) preferably based on prequalification. 

Electronic Common Technical Document Specification. ICH M2EWG. Draft Guidance. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH eCTD Specification V 2.0. February 12, 2002. 

The recent literature on microwave-assisted chemistry has reported a multitude of different effects in chemical reactions and processes and attributed them to microwave radiation. Some of these published results cannot be reproduced, however, because the household microwave ovens employed often have serious technical shortcomings. Published experimental procedures are often insufficient and do not enable reproduction of the results obtained. Important factors required for qualification and validation, for example exact records, reproducibility, and transparency of reactions/processes, are commonly not reported, which poses a serious drawback in the industrial development of microwave-assisted reactions and processes for synthesis of fine chemicals, intermediates, and pharmaceuticals. Technical microwave devices for synthetic chemistry have been on the market for a while (cf a.m. explanations) and should enable comparative investigations to be conducted under set conditions. These investigations would enable better assessment of the observed effects. It is, furthermore, possible to obtain a better insight into the often discussed (nonthermal) microwave effects from these experiments (Ref. [138] and Chapter 4 of this book). Technical microwave systems are an important first step toward the use of microwave energy for technical synthesis. The actual scale-up of chemical reactions in the microwave is, however, still to be undertaken. Comparisons between microwave systems with different technical specifications should provide a measure for qualification of the systems employed, which in turn is important for validation of reactions and processes performed in such commercial systems. 

Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) ICH, 2001) The CTD provides for a harmonized structure, content, and format for new product applications. The document is divided into four separate sections. The four sections address the application organization (M4 organize), the quality section (M4Q), the safety section (M4S) and the efficacy section (M4E) of the harmonized application. Drug metabolism and pharmacokinetic data should be summarized in the safety section that includes the nonclinical overview, nonclinical written summaries, and nonclinical tabulated summaries. More specifically, in Section 2.6.4.S metabolism (interspecies comparison) of the written summaries, the following data should be included ... 

The energy performance of a dryer and a drying process is characterized by various indices such as volumetric evaporation rate, surface heat losses, steam consumption, unit heat consumption, and energy (thermal) efficiency. Of all these indices, the energy efficiency / is most frequently quoted in technical specifications. It commonly relates the energy used for moisture evaporation at the solids feed temperature ( , ) to the total energy supplied to the dryer ( ,) ... 

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