Pharmaceutical industry process cycle

System qualification is a process that ensures that an analyzer system is installed and operated according to requirements that are aligned with the intended use of the system. The commonly used approach in the pharmaceutical industry is the system life cycle or SLC process. In the SLC approach, the definition of intended use, design, configuration, installation and operation is linked and documented over the lifetime of a system. 

ABC Pharmaceutical Industries information. The equipment preparation pages of the master batch record specify the validated sterilization processes to be employed in the preparation of the equipment for (product name) USP. Cycle sterilization parameters are defined along with attributes such as loading patterns and the mechanics of operating the sterilizing equipment. The following lists the sterilization cycles utilized for the equipment required in the processing of (provide product name) USP ... 

Figure 3.1 identifies the major stages in a solvents life cycle production, transport, use, and disposal. Although there are many opportunities to recycle and reuse solvents they will eventually need to be disposed of as waste. As an example, consider a process which uses tetrahydrofuran (THF). A 1 kg reduction in the amount ofTHF would reduce the CO2 emissions from THF production by about 16kg [3], This reduction in CO2 emissions does not account for the savings in transportation or disposal of excess THF in a process. Therefore, reductions in solvent use by the pharmaceutical industry not only reduce the waste it produces as part of its processes but also the waste that would be generated from the manufacture of additional solvent. 

Fig. 7.2 illustrates for the pharmaceutical industry 1) the major milestones or events in the process development cycle and (2) a typical sequence of events. The process... 

The manufacturing department ships the product in accordance with manufacturing guidelines, based on the receipt of valid purchase orders. The product documentation includes a Declaration of System Validation with statements from Hewlett-Packard that the software was developed and tested according to the Hewlett-Packard Analytical Software Life Cycle, a process that has been certified for ISO 9001 quality standard and for the information technology quality system (ITQS) compliance and that has been inspected by representatives from both computer validation companies and the pharmaceutical industry. 

In the pharmaceutical industry most solid compounds are crystallized in batch operations, i.e., the crystalline product is isolated at the end of the operating cycle. Many bulk chemicals, such as table sugar, are prepared through continuous processes, in which the product is collected throughout the crystallization cycle. Batch crystallization produces a narrower range of particle size and may afford better control for the efficient crystallization of molecules from complex mixture [14]. 

In the pharmaceutical industry, more than one-third of the new drug candidates that enter preclinical and clinical evaluations for safety are dropped from development because of unanticipated toxicity. This represents a tremendous loss of time and resources, which results in increased cycle time, increased development costs, and significant delays in the availability of beneficial drugs to clinicians and their patients. Therefore, to reduce the number of failures in late development caused by safety issues, the potential toxic liability of new chemical entities is now being evaluated much earlier in the discovery process. 

For reasons of economy, short drying cycles are of course highly desirable, and much time and effort are often devoted by the pharmaceutical industry to improve (shorten) historical drying cycles. A mature consideration of these seven factors must, however, lead to the important conclusion that for any given product formulation and vial type, there is a limit to any process cycle reduction that can be achieved, without putting the quality of the dried product at risk. 

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