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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.