Glossary · GxP: good practices
EU GMP Annex 15 (qualification and validation)
Also known as: Annex 15, EU GMP Annex 15, Qualification and Validation (Annex 15)
EU GMP Annex 15 is the annex of EudraLex Volume 4 that sets out the principles of qualification and validation for the facilities, equipment, utilities and processes used to manufacture medicinal products. The version in force dates from 2015 and asks that the scope and extent of qualification and validation be based on a justified and documented risk assessment.
- GxP
- Pharma
- EU
In one sentence
EU GMP Annex 15 (2015) sets out qualification of equipment and utilities and validation of processes, cleaning and test methods in medicine manufacturing.
Example
A manufacturer transferring a product to a new site writes a validation master plan under Annex 15, qualifies the new equipment, validates the process and the cleaning procedure, and manages the transfer through change control.
How it applies
- Organizing: Qualification and validation activities are planned, for example in a validation master plan, and carried out by trained staff under approved protocols.
- Qualification: User requirements, design qualification, factory and site acceptance tests, and IQ, OQ and PQ.
- Validation: Process validation (traditional, continuous process verification or hybrid), verification of transportation, packaging validation, qualification of utilities, validation of test methods and cleaning validation.
- Change control: Planned changes are assessed for their effect on the validated state and may trigger requalification or revalidation; see change control.
- Technical documentation: Annex 15 accepts documents from suppliers or engineering where they are adequate and controlled; protocols, reports and the reasoning behind risk-based scoping must be traceable.
Annex 15 vs. Annex 11
Annex 15 covers qualification and validation of facilities, equipment, utilities and processes. Annex 11 covers computerized systems, with its own requirements for data, audit trails and security. A computerized system that controls equipment is usually addressed under both: the equipment is qualified under Annex 15 and the software validated under Annex 11.