Control of Starting Materials

Part II Composition, Method of Preparation, Controls of Starting Materials, Control Tests on Intermediate Products, Control Tests on the Finished Product, Stability and Other Information (Placebos, Comparator Products, Adventitious Agents, etc.)... 

Part ICl contains an expert report on the chemical, pharmaceutical, and biological documentation. Topics presented include composition, method of preparation, control of starting materials, control tests on intermediate products, control tests on hnished product, stability, and information on the pharmaceutical expert. An example is given in Exhibit 8.5. 

So why aren t today s engines made of ceramics The short answer is that, unlike metals, ceramics cannot bend and deform to absorb impacts. Intense research is currently under way to solve the problem of ceramic brittleness, with some success. Improved resistance to fracturing, for example, can be attained by careful quality control of starting materials and processing. As we shall see in the next section, brittleness can also be combated by compositing ceramics with other materials. 

Validation of the Process Part II C Control of Starting Materials... 

MAA application section IIC3—control of starting materials... 

Control of Starting Materials and Intermediate, Bulk, and Finished Products.16.2 WHO-BASE 19... 

Control of starting materials and intermediate, bulk, and finished products... 

Control of starting materials, including baseline data both on... 

Because of their often complex and variable nature, and the number and small quantity of defined active ingredients, control of starting materials, storage and processing assume particular importance in the manufacture of herbal medicinal products. 

Control of Starting Materials, Intermediate, Bulk and Finished Products. . 7.4... 

Table 2-1 lists the headings under which information should be provided in Part II, according to the Notice for Applicants. NMR methods are most likely to appear in Parts lie, HE and IIF which describe respectively the control of starting materials, control of finished product and stability of active ingredient and finished product. As a general rule, any analytical methods should be described in sufficient detail to enable the procedures to be repeated if necessary, for example, by an official laboratory. 

Much like polymers, organic chemicals have their own set of properties that can be used to provide quality control techniques. These properties can be very similar to those used in polymer systems and can include glass transition temperatures, melting (temperature, endialpy), crystallization (temperature, enthalpy), decomposition (thermal, oxidative), reaction (widi various other materials) and more. Thus, the techniques that could be used for quality control of starting materials, process intermediates and final products are similar to those used for polymers. 

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