Validation (Drug Manufacture)
(การตรวจสอบความถูกต้อง (การผลิตยา))
Definition
Validation (Drug Manufacture) (การตรวจสอบความถูกต้อง (การผลิตยา)) Hard Skill
Validation in drug manufacture refers to the documented process of ensuring that manufacturing processes, equipment, and systems consistently produce products meeting predetermined quality standards and regulatory requirements.
Expertise Level
Level 1
Basic
1. Understands basic principles and purpose of validation in drug manufacturing.
2. Can assist with routine validation documentation and record-keeping.
3. Familiar with common terminology and regulatory guidelines related to validation.
Level 2
Intermediate
1. Can plan and execute validation protocols for processes, equipment, and systems.
2. Able to analyze validation data and identify deviations or non-conformities.
3. Ensures compliance with regulatory requirements during validation activities.
Level 3
Advanced
1. Designs and leads comprehensive validation strategies across manufacturing processes.
2. Develops and approves complex validation protocols and reports.
3. Integrates regulatory changes and industry best practices into validation processes to optimize quality assurance.
