Allgemein, News
Good Distribution Practice: Brief Overview
“In theory there is no difference between theory and practice. In practice there is.” – Yogi Berra Good distribution practice, also known as GDP, was originated by the World Health Organisation (WHO) and the European Economic Community. It was written as a set of guidelines for the pharmaceutical suppliers. Today these guidelines are issued by various regulatory bodies. Who is responsible for GDP and why is it important? The marketing authorisation holder is responsible for GDP which is useful for prevent and guarding against risks that can cause dire consequences through standards of practice. The WHO describes GDP as…
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News
GxP Compliance: Back To Basics
“Make it right today, better tomorrow”. -F. Schnettelker If a drug is being produced in a GxP compliant manner, there are various specific guidelines that must be adhered to. In principle, computer systems associated with the life cycle of a product must meet certain criteria. The pharmaceutical industry must follow certain rules: Secure logging All system activities related to research, development and manufacturing must be registered by the users. This logged data cannot be amended, even by the admin responsible. Auditing Reconstruction of decisions and potential mistakes made in the development and manufacturing of a regulated product must be documented…
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Allgemein
OpenFDA Website Launch
The FDA has recently launched an online research project which is still in beta. However, this is not for clinical use as stated on their website: https://open.fda.gov/ The webpage is very user friendly as it is based on a simple lay out and presentation. Data can be found in three subheadings: Drugs, devices and foods. This features adverse events, labelling, and enforcement reports. One can find posts related to pharma topics presented in blog fashion and a series of relevant links at the bottom of the site. The website also features links to API basics and status as well as…
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