RegionWhat is Device History Record in pharma?
A Device History Record in the pharmaceutical industry is a comprehensive document containing all the records related to manufacturing and tracking a medical device. It proves the device was manufactured according to the Device Master Record (DMR) and adheres to regulatory requirements. The DHR includes manufacturing dates, quantities, distribution dates, testing documentation, labeling documentation, and unique device identifiers (UDI, UPC, etc.). It helps identify deviations, trace the root cause of defects, and ensure compliance with regulatory standards like FDA 21 CFR Part 820 and ISO 13485.
What are the key components of DHR?
Here are the key components of (DHR) in the pharmaceutical industry:
- Raw Material Inspection: Documentation of the receipt and inspection of raw materials, including certificates of analysis and certificates of conformity.
- Manufacturing Records: Documentation of the manufacturing process, including batch records, production records, and process validation records.
- Testing Records: Documentation of testing and inspection performed during the manufacturing process, including test protocols, test reports, and inspection records.
- Deviation and Corrective Action Records reflect our unwavering commitment to quality control. They document any deviations or corrective actions taken during the manufacturing process, including thorough root cause analysis and comprehensive corrective action plans.
- Change Control Records: Documents that need changes to the manufacturing process, including change requests, change orders, and change implementation plans.
