FDA GMP
(การปฏิบัติตามหลักเกณฑ์ GMP ของ FDA)
Definition
FDA GMP (การปฏิบัติตามหลักเกณฑ์ GMP ของ FDA) Hard Skill
FDA GMP refers to the regulations established by the U.S. Food and Drug Administration to ensure that products are consistently produced and controlled according to quality standards, focusing on manufacturing practices that guarantee product safety and efficacy.
Expertise Level
Level 1
Basic
1. Understands the fundamental principles of FDA GMP regulations.
2. Familiar with basic manufacturing practices and hygiene requirements.
3. Able to follow standard operating procedures (SOPs) related to GMP.
Level 2
Intermediate
1. Applies FDA GMP guidelines to oversee production processes and ensure compliance.
2. Identifies and reports deviations from GMP standards effectively.
3. Participates in quality audits and supports corrective actions.
Level 3
Advanced
1. Leads implementation and continuous improvement of FDA GMP compliance programs.
2. Develops and manages training programs on GMP requirements for staff.
3. Evaluates complex quality systems and drives strategic solutions to maintain FDA compliance.
