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
Category: Pharmaceutical Blog
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.
The ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products.
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.
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.
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.
Q1 Scientific staff attended the recent training course on Stability Testing in Pharmaceutical Development and Manufacturing, held in Amsterdam on 5-6 June 2014. Topics covered included ICH guidelines, QbD, ASAP and photostability