The Pharma Journal

 ICH Q9 guidelines are known as Quality Risk Management issued by International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This guidelines gives description on how the Quality Risk Management can be applied to uphold the quality of medicines in Pharmaceutical Industry. This guideline also covers development, Manufacturing and Distribution including whole life cycle of medicinal products. Quality Risk Management can be defined as a systematic assessment of risks and a approach to control and communicate such risk to enhance Quality of product. Principle of Quality Risk Management: The principle includes Evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient and the level of effort, formality and documentation of the quality risk management process should be in correspondence with the level of risk. Process of Quality Risk Management: The Quality Risk Management f...

Common Technical Document is defined as a set of specifications which is used for making any application for registration of medicines. This system is used across US,EU and Japan Australia etc. CTD is maintained by  International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The main purpose of this Document set is to combine all safety, efficacy and quality data which are required for regulatory review process by Authorities ultimately for approval of drug registration.             As we are in 2020, The hard copy of documents are not practical in majority countries. All the submissions to the Regulatory Authority shall be done through various eCTD software's  online. The harmonized CTD specifications are given by ICH guidelines ( Multidisciplinary  guidelines  M4 ).                     The eCTD is defined as an interface for in...