Donepezil hydrochloride was first synthesized by medicinal chemist in December 1986, after that, process studies such as selection of starting materials (synthesis route's decision), proposal of optimum crystalline form, reaction condition, reaction post-treatment, purification, drying, particle control method, etc. were energetically carried out by process chemist, and the industrial manufacturing process was established. This research paper describes the history of development of the manufacturing process for donepezil hydrochloride and the actual development of the drug substance throughout the product lifecycle. It also discusses whether continual improvements defined in the ICHQ10 have been achieved throughout the product lifecycle.

In the pharmaceutical industries, the Data Integrity is becoming a big issue. In order to prevent the data loss on the computer failure, the computer data should be backed up and the backup data should be exact, complete, and secure from alteration, inadvertent erasures, or loss. If the backup data is corrupted when the data restoration is required on the computerized system failure, the data could not be recovered. Therefore, the backup should be periodically verified if it is complete, reliable, and ready for use. When the hard disk drive is used as a backup media, one year of the verification frequency would be enough.