Recipe Administration

A modern LIMS includes a module designed for the administration of recipes for the various products. This includes specifying exact quantities or relationships of individual components of a product. With a recipe administration module, each recipe is subdivided into two different manufacturing phases a static part (i.e., gross-mixing ratio) and a dynamic part. The static part describes which quantities of the individual components are used for the manufacturing of the product. The quantities are specified as absolute units or as ratios. The dynamic part describes dependencies of the quantities of the components on different parameters, such as time, temperature, pH-value, or pressure. With the recipe module, various calculations and evaluations can be carried out. 

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The hardware architecture must be flexible with respect to bus technology, expansions, network integration and modem access. The use of standard components and software and also a maintenance-friendly design will simplify qualification and validation for both the manufacturer and the user. It is advisable to design the machine control separately from the data management (i.e. recipe and data administration) to ensure that if there is a failure, loss of data does not result in losing a batch. Pro-... 

Some of the publications consulted for this review offered insufficient description of use, lacking information about route of administration and the recipes concerning the medicines , as can be observed in Tables 1 and 2. In the cases in which they are described, recipes may include teas (infusion or decoction), bottled brews, or extract - in natura. While, route of administration may be ingestion and topical (in the form of bathing). 

Header Header stands for the administrative information in the recipe ... 

Many batch plants, especially those used to manufacture pharmaceuticals, are certified by the International Standards Organization (ISO). ISO 9000 (and related ISO standards 9001-9004) state that every manufactured product should have an established, documented procedure, and the manufacturer should be able to document that the procedure was followed. Companies must pass periodic audits to main ISO 9000 status. Both ISO 9000 and the U.S. Food and Drug Administration (FDA) require that only a certified recipe be used. Thus, if the operation of a batch becomes abnormal, performing any unusual corrective action to bring it back within the normal limits is not an option. In addition, if a slight change in the recipe apparently produces superior batches, the improvement cannot be... 

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