Category: Pharmaceutical Blog

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.




read more about Need Ultra Low (-80) Cold Storage?
Need Ultra Low (-80) Cold Storage?

Need Ultra Low (-80) Cold Storage?

If you have a requirement for ultra low storage (-80 deg), talk to Q1 Scientific today. Samples can be returned to you at controlled temperatures.


read more about Are your Photostability Testing Requirements up to date?
Are your Photostability Testing Requirements up to date?

Are your Photostability Testing Requirements up to date?

All companies developing or manufacturing pharmaceutical drugs, require a robust photostability testing process to ensure product quality and regulatory compliance. Inadequate testing can result in costly delays and lost revenue.


read more about Guidance for ANDAs….Did you know?
Guidance for ANDAs….Did you know?

Guidance for ANDAs….Did you know?

ANDA submission batch samples should be stored for 1 year after approval of the ANDA and samples of the drug product used for bioequivalence studies must be stored following the requirements listed in 21 CFR 320.38 and 21 CFR 320.63.



read more about Q1 Scientific – Prepared for any power interruption resulting from ESB strike

Q1 Scientific – Prepared for any power interruption resulting from ESB strike

The Q1 Scientific facility is fully supported with a back up power generator, which cuts in automatically in the event of electricity loss resulting from any ESB strike. Each environmental chamber operates independently, with separate temperature and humidity controls and all chambers are continuously monitored by a computerised monitoring system with back up alarms and … Continued