Intermediate and Finished Products

Wort is the resnlt of enzymatic hydrolysis of the grist that results from the conversion of starch and proteins into solnble and simpler carbohydrates and peptides, respectively (Chapter 14). The most important wort properties are soluble solids or extract yield ( Plato), percent fermentable sngars, viscosity, pH, color, and alpha amino nitrogen (AAN), also known as free amino nitrogen (FAN). The most relevant determination is the wort density at the end of mashing because it allows processors to calculate the efficiency of solnbilizing the available extract. The most practical way is to determine the density as Plato using a pycnometer (ASBC Wort 3 method). The total extract is calculated by the volume of wort recovered x density x Plato. The volume and density measurements must be referenced to 20 C. Another useful assay 

Wort separation by filtration is critically important in brewing operations since it is considered the bottleneck of the process. The efficiency of lautering is measured in terms of filtration time and wort turbidity. The recovered wort should be low in turbidity or haze (Gales 2002). The 3-glucans associated with barley and adjuncts increase wort viscosity and turbidity. The use of P-glucanases increases filtration rate and decreases turbidity (Barnes 2006). 

Beer is one of the cereal-based products that has more quality control parameters because it is subjected to many processing steps and is produced with a wide array of different raw materials. In addition, and when compared to other alcoholic beverages, beer is unique because it is unstable in the final package. 

The same quality control parameters described for beer ingredients, enzymes, and the various processing steps are applied for alcoholic spirits and fuel ethanol. Since most distilled beverages are aged, the quantification of flavorful compounds via 

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Raw-materials, intermediate, and finished-product inventories Cost of handling and transportation of materials to and from stores Cost of inventory control, warehouse, associated insurance, security arrangements, etc. 

Are the ABC Co. products currently contracted for manufacture or repackaging specifically listed m the contractual agreement (Please attach a list of pounds received and shipped of ABC Co. owned raw materials, intermediates and finished products for the last twelve months.) ... 

Does contractor provide month-end balances to ABC Co. of ABC Co. owned raw materials, intermediates and finished product volumes ... 

Storage facilities for raw materials and intermediate and finished products may be located in isolated or adjoining areas. Hazardous materials should be isolated because they menace life and property when stored in large quantities. 

Phenol is the starting material for numerous intermediates and finished products. About 90% of the worldwide production of phenol is by Hock process (cumene oxidation process) and the rest by toluene oxidation process. Both the commercial processes for phenol production are multi step processes and thereby inherently unclean [1]. Therefore, there is need for a cleaner production method for phenol, which is economically and environmentally viable. There is great interest amongst researchers to develop a new method for the synthesis of phenol in a one step process [2]. Activated carbon materials, which have large surface areas, have been used as adsorbents, catalysts and catalyst supports [3,4], Activated carbons also have favorable hydrophobicity/ hydrophilicity, which make them suitable for the benzene hydroxylation. Transition metals have been widely used as catalytically active materials for the oxidation/hydroxylation of various aromatic compounds. 

In trying to grab the other companies, Von Schnitzler met the government opposition cleverly. He did not seek immediate control he suggested that the Economic Ministry appoint Farben men as "trustees for the Reich," with authority to "continue the works or to close them and make use of the stocks of raw materials, intermediates, and finished products." Von Schnitzler pointed out that 85 per cent of coal tar and intermediates produced by Farben for the Nazi war machine came from Ludwigshafen in western Germany. Strategy demanded that Farben find safer eastern plants such as these in Poland. 

The chemical industry is a sub-industry of the process industry. The process industry is characterized by production in processes that can be convergent as well as divergent. The process industry consists of firms that "add value by mixing, separating, forming and/or chemical reactions by either batch of continuous mode" (Wallace 1992 reviewed by Den-nis/Meredith 2000, p. 683). Products in process industries can be intermediates and finished products at the same time sold or used for others products. Other sub-industries in the process industries are oil and gas, steel and metals, pulp and paper or pharmaceuticals as well as parts of consumer goods such as food production. 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of the manufacturing environment, raw materials, in-process intermediates, and finished products. 

Samples of intermediates and finished products taken for analysis are recorded, stating the time, date, and conditions for these samples. Deviations in operating conditions and out of specification (OOS) conditions in samples are reported and investigated. Figure 9.2 shows a mechanism for production and in-process controls. 

Packaging, Identification, and Labeling of APIs, Intermediates, and Finished Products... 

Proper identification of raw materials, intermediates, and finished products is necessary to prevent misuse and mix-ups. Labels are controlled and accounted for to prevent mislabeling. If required, packages may be sealed to provide an alert of mishandling or unauthorized tempering. 

Laboratory controls commence with sampling and testing of incoming materials according to written procedures. Some aspects of the tests include identity, quantity, purity, activity, heterogeneity, stability, sterility, and safety. Intermediates and finished products are tested in accordance with preset... 

There are occasions where new analytical methods have to be developed specifically for testing raw materials, intermediates, and finished products that are not covered by compendial methods. In these situations, the analytical methods are required to undergo a validation process to ensure they are suitable. One or more of the following parameters as defined in Exhibit 9.10 must be validated for newly developed analytical methods ... 

Quality records must be maintained to document all tests pertaining to the raw materials, intermediates, and finished product. 

Crude oil, intermediate, and finished products are stored in tanks of varying size to provide adequate supplies of crude oils for primary fractionation mns of economical duration to equalize process flows and provide feedstocks for intermediate processing units and to store final products prior to shipment in adjustment to market demands. Generally, operating schedules permit sufficient detention time for settling of water and suspended materials. 

Acceptance criteria must be key to achieve appropriate qualification, verification, and individual validation. Acceptance criteria may be consist of various specifications of intermediate and finished products for medical devices. Acceptance criteria also may control parameters for operation of processing equipment and utilities used. 

The probability of fires and explosions at plants producing various silicone monomers and polymers is significant, since many kinds of raw materials, intermediate and finished products are flammable and explosive. Therefore, silicone production belongs to fire risk category A because it makes use of flammable raw materials (the flash point is lower than +28 °C). 

Handling and control, including the testing and approval, of raw materials, process aids, intermediates, and finished products. 

In the latter part of the nineteenth century new raw materials for the chemical industries became available from city gas and by-product cote oven operations. Benzene, toluene, xylene, naphthalene, phenol, cresols, and xylenols served as crudes for conversion to various intermediates used in the growing new synthetic dyestuff industry. Many of these intermediates and finished products were nitro compounds and found their way into the explosive industry. 

Allhougli niiraie esters continue to be widely used and are important explosives their cliemical properties arc described to a much lesser extent than those of C nitro compounds. This is understandable when considering the wide use of C-nitro comjHiuiids. particularly aromatic ones, not only as explosives but in a great variety of uses as intermediates and finished products, l or this reason the excellent monograph of l atai. series edited by M. Feuer (1). does not cuniatn a chapter on 0 nitro compounds and the only review papers dedicated solely to O nitro compounds were by Boschan. Merrow, Van Dolah (2] and Connon 3l. 

If time limits are specified in the master production instructions, these limits should not be exceeded, to ensure the quality of intermediates and finished products. The less is known about the constituents responsible for the therapeutic activity, the more strictly this rule should be obeyed. Such time limits, however, may be inappropriate when processing to achieve a target value (e.g. drying to a predetermined specification) because completion of processing steps is determined by in-process sampling and testing. 

All qualification procedures for equipment and services of the manufacturing process must be completed before starting the PV process. A manufacturing process achieves the status of validated if all batches defined in the PV plan fulfill the specifications for the intermediate and finished products. 

As the chemical industry grows in size, it will find it is able to meet increasingly the volume criteria for pipeline transportation, and it will be utilizing this low cost mode in increasing instances for raw materials, intermediates, and finished products. 

Packaging, identification and labeling of APIs, intermediates and finished products... 

For injectable products, consideration should be given to monitoring the water and the intermediate and finished product for endotoxins, using an established pharmacopoeia method that has been validated for each type of product For largevolume infusion solutions, such monitoring of water or intermediates should always be... 

There should be a system to identify the inspection status of all materials including raw materials, intermediates and finished products. While storing materials in properly identified locations is preferred, any means which clearly identifies the test status is satisfactory. 

All intermediate and finished products are held in quarantine and are so identified until released by the quality control department... 

The production process and sectional operation procedures shall be established for each product. The production process shall at least contain the name of the product, dosage form, formulation, requirements for process operation, the quality specifications and technical parameters of the intermediates and finished products, storage precautions, methods for calculation of theoretical, calculated and actual yields, finished products containers, requirements for packaging materials, etc. 

The quality control department shall have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials, printed packaging materials, packaging materials, and intermediate and finished products testing. 

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