Pharmaceutical manufacture critical control points

The first demonstration of solid state fluorescence of API dates back to 1961, while its in-line use for final drug product manufacturing was not demonstrated until recently." While in its infancy as a process analytical technology for real-time monitoring and product parametric real-time release, the applications identified and in some instances demonstrated include (i) blend endpoint API content nniformity detection " (ii) segregation monitoring or API content at various process critical control points and (iii) at-line tablet content uniformity determination. The fundamentals of solid-state luminescence spectroscopy for pharmaceutical solids has been covered by Brittain."... 

GMP critical control input/output points typically in order of 5 to 10% of total input/output points. This has led many pharmaceutical manufacturers to consider the use of validated independent monitoring systems for the GMP critical control points and hence alleviate validation of the control system to a Good Engineering Practice (GEP) activity based on qualihcation." Independent monitoring systems range in complexity ... 

Hazard analysis of critical control points (HACCP) has been widely used in the food industry and is becoming more commonly used in the pharmaceutical industry (Jahnke, 1997). HACCP is a tool for evaluating steps in a manufacturing process. It provides a structured thought process for GMP. The seven steps involved are ... 

Process analysis can be used to provide extra insight into the nature of the processes and products, and as such should be part of a process control philosophy that will reduce variation. They even have the ability to produce a paradigm shift in the principles of pharmaceutical manufacturing, with validated measurements taken at Critical Control Points (CCP), controlling processes in such a way that product quality becomes guaranteed by measurement, and processes which are adjusted to optimise throughput. 

The apparatus used to measure membrane bubble points is shown in its simplest form in Figure 7.7 [4], Bubble point measurements are subjective, and different operators can obtain different results. Nonetheless the test is quick and simple and is widely used as a manufacturing quality control technique. Bubble point measurements are also used to measure the integrity of filters used in critical pharmaceutical or biological operations. 

The critics of government-imposed price controls on pharmaceutical products do have a valid point. As long as the price ceilings are set above the incremental cost of producing these products, manufacturers will be tempted to sell at whatever those controlled prices are, because they earn at least a positive margin toward the recovery of fixed costs. The problem is that the price ceilings may be set at levels far below fully allocated fixed costs per unit. If every payer followed that strategy, pharmaceutical companies would soon become insolvent. 

In order to limit the risk so contamination of sterile preparations during their manufacture, certain pharmaceutical operations must be carried out in zones, the environment of which is controlled. These zones may correspond either to an entire room, a hood with laminar air flow or a cubicle, or to a much more localized area of these enclosures, called the critical point. 

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