"Cell processing facility permit" "Cell processing facility permit"
Recently, the number of people searching for this keyword has increased noticeably.
The process of handling and processing cells Safety is the top priorityBecause of this,
A procedure to verify whether certain standards have been met is absolutely necessary.
SC301 Clinic according to relevant standards Officially obtained cell processing facility permitdid,
domestic 50th As an licensing authority, we operate based on a responsible management system.
Today, we will discuss what a permit means and what patients should definitely check. Management pointsI will summarize it for you.
📋 SC301 Clinic Cell Processing Facility Permit Summary
License — Cell Processing Facility License (No. 139) Facility Name — SC301 Clinic Address — Chan & Chan Tower, 3F (B1), 611, Yeongdong-daero, Gangnam-gu, Seoul Representative — Shin Dong-jin Human Cells Handled — Autologous (Adipose-derived Stem Cells) Permit Date — 2026.02.10 Expiration Date — 2029.02.09
⚠️ This article is intended to provide information regarding "approval and management standards" and is not intended to assert or guarantee therapeutic efficacy.
🔬 What is a Cell Processing Facility Permit?
To summarize simply, it is like this.
The approval of the cell processing facility is separate from 'specific treatment results',
Required when handling or processing human cells, etc. Facilities, Equipment, Personnel, and Quality Management SystemIt is a procedure to verify whether it is equipped.
There are three main key items to check.
① Prevention of pollution ② Standardized Procedure (SOP) ③ Traceability
The essence of the permit is to verify that these items are being operated systematically.
✅ 4 Management Standards Linked to Patient Safety
— Use this as a checklist before the consultation.
The cell processing facility is, above all "management" is the key.
Here are 4 key points to check during a consultation.
1️⃣ Environmental management for the prevention of contamination and infection
During the cell handling stage, space, hygiene, and movement management are important to minimize external contamination factors.
2️⃣ SOP (Standard Operating Procedure) Based Operation
To ensure that procedures do not vary depending on the person in charge, operate based on step-by-step SOPs, and Leaving a record of verificationThis is the key.
3️⃣ Traceability and Record Keeping
Key information on how the process was conducted must remain, and be verifiable if necessary Establishing a record-keeping systemThis is important.
4️⃣ Quality Control (QC) and Equipment Inspection
Equipment inspection, consumable and storage management, and operation records determine safety Basic items.
❓ FAQ — Frequently Asked Questions
Q. Does obtaining a license for the cell processing facility improve the effectiveness?
Approval is not a concept that implies or guarantees therapeutic effects.
However, the safety and quality control standards required in the cell handling and processing process
A foundation to be equipped and operated Confirmation procedure.
Q. What does 'autologous adipose-derived stem cells' mean?
Human cells, etc. handled as listed in the permit rangemeans
Individual conditions and plans through consultation with medical staff
It is important to be informed about suitability, precautions, and possible side effects.
Q. What questions should I ask during the consultation?
Please ask the following four things specifically.
① Suitability for the individual's condition ② Step-by-step process / Schedule ③ Expected side effects/precautions ④ Follow-up plan
🏥 Wrapping up
SC301 Clinic complies with relevant standards,
So that patients can receive consultation and treatment with peace of mind
safetyand ethicstop priorityWe will operate it as.
If you need consultation regarding this, please feel free to contact us.
