Glossary
Design History File (DHF)
What is DHF in Pharma?
A Design History File (DHF) is a compilation of documents and records that captures the design history of a medical device, pharmaceutical product, or biotechnology product, from its conception to its commercialization. The DHF provides a chronological record of the design process, including the design inputs, design outputs, design verification, design validation, and design changes. DHF is a file that contains all the documentation related to the design of a product, including the design process, testing, validation, and changes made to the product over time.
What is the importance of DHF in pharma?
Here is the importance of a (DHF) in the pharmaceutical industry:
- Regulatory Compliance: A DHF is required by regulatory agencies, such as the FDA, to ensure that medical devices and pharmaceutical products are designed and developed in accordance with regulatory requirements.
- Product Safety: A DHF helps ensure that products are safe for use by capturing the design process and testing data.
- Product Quality: A DHF helps ensure that products meet the required quality standards by capturing the design process and testing data.
- Design Optimization: A DHF provides a chronological record of the design process, allowing for design optimization and improvement over time.
- Audit Trail: A DHF provides an audit trail of the design process, allowing for traceability and accountability.
