Biopharmaceutical Process Validation Research Assignment

Biopharmaceutical Process ValidationNameCourseTutorDate
Part 1: Sequence of Process Validation Activities
Process validation can be defined as the procedure that is followed in the collection of data and the evaluation of the collected data. The process begins at the design stage and goes through the commercial production process, and then a scientific evidence is established that the process that a certain product has gone through is capable of delivering a quality product that is fit for consumption CITATION WHO13 \l 1033 (WHO, 2013). As such, we can view process validation as a series of activities that takes place over the lifecycle of the product that is being produced and the whole process. There are three main stages of the process validation process for pharmaceutical products.
Stage One- Process Design
At this stage, the commercial manufacturing process is defined. It mainly depends on the knowledge that has been gained through the development of scale-up activities. Most of the early process design experiments do not need to be performed under the CGMP conditions that are used for the drugs that are used in the commercial distribution. However, the fact that they are not performed under the CGMP conditions does not mean that there should be a compromise of the sound and scientific principles that are involved. Good documentation process should be carried out and it should be consistent with the Pharmaceutical Quality System requirements and practices CITATION WHO13 \l 1033 (WHO, 2013).
The designing of an efficient process control approach depends on the process knowledge and the understanding that is obtained. The designing of experimental studies can play a great role in developing the process knowledge by revealing the relationships between the variable inputs and the outputs. In this case, the variable inputs can be the component characteristics and the various process parameters. On the other side, the resulting outputs can be the materials used in the process and the final product of the whole process CITATION EMA16 \l 1033 (EMA, 21st November 2016). The risk analysis tools can be used to screen the potential variables for the design of the experiment so as to minimize the total number of the experiments that are performed while at the same time maximizing the knowledge that is obtained.
There are other activities such as experiments and demonstrations that play a great role in the evaluation of certain conditions and provide a prediction of the performance of the commercial process. Such activities can also be used as a good source of information to be used to model and at the same time simulate the commercial process that is taking place at that particular time. Simulations that are done by the help of the computer on the unit operations provide a good understanding and can help to avoid problems that arise as a result of commercial sales.
As a manufacturer, there are various gauges that can be used to establish a proper process control for each of the units that are used in the operation. However, you need to remember that proper knowledge and understanding is the basis for all the strategies that you will undertake in your operations. The policies can be designed in such a way to reduce the inpu...