Multual Recognition Agreement (MRA) HPRA / Ireland has been listed by the US Food and Drug Administration (FDA) as part of the mutual recognition agreement between the EU and the US
Category: Pharmaceutical Blog
Temperature Controlled Transport Temperature controlled shipping is the transport of goods that are sensitive to changes in climatic conditions.
Stability Sample Management System Q1 Scientific is a stability storage facility, providing industry-leading temperature-controlled storage to manage sample inventory.
Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued
Forced Degradation Forced degradation is an important part of the drug development process as it provides knowledge about the degradation chemistry of drug substances and drug products.
Definitions Reference samples are retained to fulfil two purposes; firstly to provide a sample for analytical testing and secondly to provide a specimen of the fully finished product. They serve as a record of the batch of finished product or starting material and can be assessed in the event of, for example, a dosage form … Continued
ICH refers to The International Council for Harmonisation, which regulates the Technical Requirements for Pharmaceuticals for Human Use. The ICH was founded in 1990 with the aim to internationally harmonise the regulatory authorities and pharmaceutical industries of Europe, Japan and the United States. From its inception, the ICH has contributed to advancing public health through: Developing and … Continued
What is a temperature/humidity controlled enclosure? “Any device which provides a space in which temperature and/or humidity is controlled.
Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation.
What is ICH? ICH is the International Council on Harmonisation of technical requirements for Registration of Pharmaceuticals for Human Use.