Obligations of pharmaceutical

The Japanese PAB notification no. 158 [19] and No. 660 [19a] detail the obligation of pharmaceutical manufacturers by defining the validation standards enforced from 1996 onward. The purpose of validation is presented as follows to validate that buildings and facilities of a manufacturing plant and manufacturing procedures, processes and other methods of manufacturing control and quality control yield anticipated results, and to ensure the constant manufacture of products of intended quality by documenting such procedures. ... 

In this chapter, we briefly discuss the market framework that supports the pharmaceutical industry. We argue that what is needed is a reformulation of pharmaceutical stakeholder obligations through the creation of a new framework - a different mental model that commits all the components of the global healthcare system to addressing the health needs of the developing countries. 

Can a reframing of pharmaceutical stakeholder obligations change the goals of the system ... 

The current system is in crisis. The system has failed to address the needs of the developing world and it is in danger of failing to address the needs of the developed world too. But we know from the loM s report on the healthcare delivery system and from observations on the way complex adaptive systems behave that all the components of a system must share a goal in order to achieve it. So we know that reframing the obligations of one component of the system, the pharmaceuticals, will not be enough to achieve the outcomes we want. 

As mentioned above, it is an obligation of the filter user to validate the sterilization processes applied to the niter. Most often sterilizing filters will be autoclaved. The effects of a particular autoclave process on the quality and quantity of extractables obtained from filters should be evaluated using the pharmaceutical fluid that is intended to be filtered. The filtrate should be demonstrated to be particle free and biologically inert chemical extractables should not exceed the levels of contaminants allowed in the product quality specification. 

Understanding the responsibilities and obligations of sponsors in terms of GCP is fundamental knowledge, essential to conduct clinical research. Currently, most pharmaceutical firms reference the ICH GCP guideline as the minimum standard for conducting clinical trials. 

The manufacture and use of any chemical product depends on technical, economic and social factors and the interrelationship, and often the conflicting interplay, between these. It is in the area of pesticides that the influence of social factors has had the greatest impact, with the possible sole exception of pharmaceuticals. Indeed, agrochemicals have been described as the most highly regulated sector of the chemical industry. Since pesticides are by definition toxic (to the pest), it is reasonable that some control should be exercised over their use. In the United States pesticides cannot be marketed until they have been cleared and approved by the EPA, i.e. there is a legal obligation. 

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