Category: Pharmaceutical Blog

read more about HPRA & FDA Mutual agreement between EU and US

HPRA & FDA Mutual agreement between EU and US

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


read more about Environmentally Controlled Transport

Environmentally Controlled Transport

Temperature Controlled Transport Temperature controlled shipping is the transport of goods that are sensitive to changes in climatic conditions.


read more about Stability Sample Management System

Stability Sample Management System

Stability Sample Management System Q1 Scientific is a stability storage facility, providing industry-leading temperature-controlled storage to manage sample inventory.


read more about Stability testing requirements for Pharmaceuticals and Medical Devices

Stability testing requirements for Pharmaceuticals and Medical Devices

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



read more about Storage of Reference and Retain Pharmacuetical Samples

Storage of Reference and Retain Pharmacuetical Samples

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


read more about ICH Requirements for Pharmaceutical

ICH Requirements for Pharmaceutical

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



read more about Thermal Cycling / Freeze Thaw Study
Time V Temperature

Thermal Cycling / Freeze Thaw Study

Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation.