Process Validation
(การตรวจสอบความถูกต้องของกระบวนการ)
Definition
Process Validation (การตรวจสอบความถูกต้องของกระบวนการ) Hard Skill
Process Validation is the documented collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Expertise Level
Level 1
Basic
1. Understands the basic concepts and purpose of process validation.
2. Familiar with documentation requirements and validation protocols.
3. Can assist in data collection during validation activities.
Level 2
Intermediate
1. Can plan and execute process validation protocols under supervision.
2. Analyzes validation data to identify deviations and trends.
3. Ensures compliance with regulatory standards during validation.
Level 3
Advanced
1. Designs and leads comprehensive process validation strategies.
2. Interprets complex validation data to optimize and control processes.
3. Develops corrective actions and continuous improvement plans based on validation outcomes.
