Pharmaceutical manufacture process

Piachaud, B. S. Outsourcing in the pharmaceutical manufacturing process An examination of the CRO experience. Technovation, 22, 2002, 81-90. 

Yet, there are still many hurdles that must be overcome before these substances can be put to widespread use. Because ionic liquids boil at high temperatures, conventional methods of separating reaction products from solution cannot be used. Pharmaceutical manufacturing processes, for instance, often involve the process of distillation. The higher temperatures required to distill using ionic liquids (as opposed to organic liquids) would decompose many of the desired pharmaceutical compounds. 

This previous definition had been broadened after the FDA s issue of the PAT guidance document to encompass aU factors influencing the quality and efficiency of a chemical or pharmaceutical manufacturing process. Driven by developments in Six-Sigma and operational excellence programs an extended definition included such items as ... 

Identifying pharmaceuticals, whether APIs or excipients used to manufacture products, and the end products themselves is among the routine tests needed to control pharmaceutical manufacturing processes. Pharmacopoeias have compiled a wide range of analytical methods for the identification of pharmaceutical APIs and usually several tests for a product are recommended. The process can be labor-intensive and time-consuming with these conventional methods. This has raised the need for alternative, faster methods also ensuring reliable identification. Of the seven spectroscopic techniques reviewed in this book, IR and Raman spectroscopy are suitable for the unequivocal identification of pharmaceuticals as their spectra are compound-specific no two compounds other than pairs of enantiomers or oligomers possess the same IR... 

In pharmaceutical manufacturing, process validation is an exercise that requires the contribution from different departments, including quality assurance and quality control. It is a requirement for good manufacturing practice (GMP) to ensure that the final product produced is of the expected quality. 

Gallagher, A., et al. Pharmaceutical waste disposal. Sewage Ind. Waste 1954, 26 (11), 1355-1362. Seeler, T.A. Jennet, J.C. Treatment of wastewater from a chemically s)mthesized pharmaceutical manufacturing process with the anaerobic filter. Proceedings of the 33rd Industrial Waste Conference, Purdue University, West Lafayette, IN, 1978, 687-695. 

Hussain, A. S. (2001), Emerging science issues in pharmaceutical manufacturing Process analytical technologies, paper presented at the Science Board Presentations to FDA, Rockville, MD. 

The consequence of such a classification would be that ethanol would need to be replaced in pharmaceutical manufacturing processes despite it being probably the safest and greenest of all organic solvents. 

To automate operation of pharmaceutical manufacturing processes, the computer software in many instances becomes the operating procedure, and thus the following in-built functionality and performance of the computer system itself should also be examined to ensure alignment with GMP application ... 

This case study embraces the design and validation of both standard and intelligent instrament applications, and briefly discusses special instrament systems (shutdown systems and analyzer packages). The number of instruments that can be involved with the dynamic operation of a pharmaceutical manufacturing process can be large (2000 to 3000 items). In most cases, they are... 

A mixture (A) in a continuous pharmaceutical manufacturing process contains up to 10 wt% of an ingredient R [mass fraction XRA(g R/g A)]. The mixture is subjected to a reaction step in which the conversion of R is 99%. The final product (P) must contain 0.75 wt% R. To achieve this goal, a fraction/of the A fed to the process bypasses the reactor and combines with the product stream leaving the reactor to produce P. A second feed stream (B), which contains no R, enters the reactor along with the A not bypassed. The mass flow rates of A and B entering the reactor (not the process) are equal. 

By the use of various pharmaceutical manufacturing processes, (e.g., lyophilization or comminution... 

Duzick, T.C. The impact of elastomer performance on pharmaceutical manufacturing processes. Pharm. Eng. 

There is a basic concept with respect to which pharmaceutical processes should be given a higher priority over others. All pharmaceutical manufacturing processes require process validation documentation, but there is an accepted logical approach to priority selection, in the following order ... 

The main use of simethicone as an excipient is as an antifoaming agent in pharmaceutical manufacturing processes, for which 1-50 ppm is used. 

Jahnke, M. (1997) Use of the HACCP concept for the risk analysis of pharmaceutical manufacturing processes. Eur J Parenter Sci, 2,113-117. 

Table 2.3 Comparing atom economy and mass productivity for 38 late-phase and/or pharmaceutical manufacturing processes. Average number of stages 7.

Excipients comprise, in some cases, almost the entire product formulation and, in others, significantly affect product quality. Many excipients used in the pharmaceutical industry are used in much greater quantities in other industries, such as the food industry. Consistency and tightness of product specifications may not be as critical in these industries as they are in the pharmaceutical industry. Variations are inherent in many of the excipients used. Therefore, a programme must be in place which will monitor these excipients and provide the necessary assurance that they meet the quality parameters for pharmaceutical manufacturing processes. The purpose of this document is to lay out some criteria which may be utilized in gaining this level of assurance. 

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