Module 3 Quality

The quality module must contain information on the identity, characteristics, manufacturing methods, control, packaging and stability of both the drug substance and final drug product. The standard headings used to present this information are shown in Figure 6.2. 

Quality - M4Q(R1) Module 3 Quality + Module 2 Quality Overall Summary... 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

CTD consists of four modules, preceded by a Module 1 that is region-specific and includes administrative and prescribing information. Module 2 comprises of CTD summaries and overviews of the quality, non-clinical and clinical data. Module 3 contains data on quality. Module 4 consists of the non-clinical study reports and Module 5 comprises the clinical study reports. There are guidelines on the details to be included in each module and these are summarised in Box 17.2. The non-clinical and clinical overviews and summaries are equivalent to the previous Expert Reports submitted under sections IC2 and IC3 respectively of part I, data. 

Bottom line For flow streams with more than one-third liquid by volume, use good-quality modulating pilots which will be more consistent in operation on gas, liquid or mixed phase service. 

Automated manufacturing of the membrane modules has allowed for more membrane area per unit volume and for higher-quality modules. This is because automation allows for more precise glue line application on the membrane leaves. A typical industrial module that is 8-inches in diameter and 40-inches long can hold up to 440 ft2 of membrane area when automated manufacturing is employed (see Chapter 4.4.2.5). 

Module II, Data Summaries (the GAIYO in Japanese), and Module III, Quality, Module IV, Safety, and Module V, Efficacy, are common to the ICH Regions. Please refer to the ICH M4 guidelines. 

Table 1 Order of Presentation for Quality Overall Summary (Module 2) and Quality (Module 3)...

The common technical document for the registration of pharmaceuticals for human use Quality Module 3, M4Q. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva Switzerland, 2003. 

The ICH created the CTD to provide a common format for companies in the EU, US and Japan to submit information to the regulatory authorities for approval of medicinal products. Module 3 (Quality module) of the CTD contains a section, 3.2.P.2, dedicated solely to the pharmaceu-... 

The BPIX modules were built [ 10] and extensively tested at PSI [9, 11,12]. The goal of the module tests at PSI was to verify that all pixels function correctly, each ROC can be programmed properly, and all calibrations of a module produce meaningful results. All modules were graded and only the best quality modules were used in the final system. In total, 948 modules have been manufactured and tested. The carbon BPIX detector mechanics was fabricated at the University of Ziirich. 

The detectability of critical defects with CT depends on the final image quality and the skill of the operator, see figure 2. The basic concepts of image quality are resolution, contrast, and noise. Image quality are generally described by the signal-to-noise ratio SNR), the modulation transfer function (MTF) and the noise power spectrum (NFS). SNR is the quotient of a signal and its variance, MTF describes the contrast as a function of spatial frequency and NFS in turn describes the noise power at various spatial frequencies [1, 3]. 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

In the study by Hetsroni et al. (2006b) the test module was made from a squareshaped silicon substrate 15 x 15 mm, 530 pm thick, and utilized a Pyrex cover, 500 pm thick, which served as both an insulator and a transparent cover through which flow in the micro-channels could be observed. The Pyrex cover was anod-ically bonded to the silicon chip, in order to seal the channels. In the silicon substrate parallel micro-channels were etched, the cross-section of each channel was an isosceles triangle. The main parameters that affect the explosive boiling oscillations (EBO) in an individual channel of the heat sink such as hydraulic diameter, mass flux, and heat flux were studied. During EBO the pressure drop oscillations were always accompanied by wall temperature oscillations. The period of these oscillations was very short and the oscillation amplitude increased with an increase in heat input. This type of oscillation was found to occur at low vapor quality. 

---