GLGlossary
Validation.
Documented evidence that a given process or method consistently produces the result it is intended to produce.
It applies to processes such as sterilization, cleaning, packaging, and software, where inspecting each finished unit is not enough to confirm quality; you set out a plan in advance, run the testing, and keep the results on record. Validation data is examined during a KGMP audit, and which processes need to be covered can differ depending on the product and how it is manufactured. A change to a process may require validation to be repeated, so it ties into change control as well.
Related work & timing
This runs through KGMP preparation, from drawing up the protocol to executing it and writing the report. For sterile products in particular it is wise to allow generous lead time.
Basis
- Regulation on Medical Device Manufacturing and Quality Control (MFDS notification)
- ISO 13485:2016 (Medical devices — Quality management systems)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
Other terms
← Back to glossary- Regulatory approval
- Classification (device class)
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- ISO 13485
- Manufacturer and manufacturing site
- Identical, equivalent, and improved devices
- UDI (Unique Device Identification)
- CB test report
- Risk management