ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. It establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.
What is ICH stability testing?
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug ...
What is ICH purpose?
The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration.
How do I check ICH?
Count the number of small lines in between the bigger, numbered lines on your measuring tool. Since each of the numbered lines represents an inch, the number of lines in between them determines how your tool breaks inches down into fractions. If there is 1 unnumbered line, the inches are broken down into halves.
What do you mean by ICH?
ĭk. A contagious disease of freshwater fishes, caused by a ciliated protozoan (Ichthyophthirius multifiliis) and characterized by small white pustules on the skin and eyes. noun. 3.
What is the primary purpose of ICH?
A primary purpose of the ICH is to: Minimize the need for redundant research. The ICH GCP Guidelines: Set standards for the design, conduct, monitoring and reporting of clinical research.