Abstract: Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.
Abstract: The area of liberty, security and justice within the
European Union is still a work in progress. No one can deny that the
EU struggles between a monistic and a dualist approach.
The aim of our essay is to first review how the European law is
perceived by the rest of the international scene. It will then discuss
two main mechanisms at play: the interpretation of larger
international treaties and the penal mechanisms of European law.
Finally, it will help us understand the role of a penal Europe on the
international scene with concrete examples.
Special attention will be paid to cases that deal with fundamental
rights as they represent an interesting case study in Europe and in the
rest of the World. It could illustrate the aforementioned duality
currently present in the Union’s interpretation of international public
law. On the other hand, it will explore some specific European penal
mechanism through mutual recognition and the European arrest
warrant in the transnational criminality frame.
Concerning the interpretation of the treaties, it will first, underline
the ambiguity and the general nature of some treaties that leave the
EU exposed to tension and misunderstanding then it will review the
validity of an EU act (whether or not it is compatible with the rules of
International law).
Finally, it will focus on the most complete manifestation of liberty,
security and justice through the principle of mutual recognition. Used
initially in commercial matters, it has become “the cornerstone” of
European construction. It will see how it is applied in judicial
decisions (its main event and achieving success is via the European
arrest warrant) and how European member states have managed to
develop this cooperation.