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GMP Case Study: Lessons from FDA 483s & Warning Letters

 


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GMP                 GMP ( 湮 )                  (/)

 

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(/ѡ濵)

 

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ǰ SOP, SMF(Site Master File), ϼ, ݼ/븮̼ /, , ӻ/ӻ , CTD(Common Technical Document),   ,   Ŵ GMP (/)մϴ.

 

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GMP Ģ ö ߽ɿ ΰ, ܱ ̵ΰ "current practices" , ǰ GMP  񽺿 湮 񽺸 մϴ.

 

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Ʒ 湮 ̿ܿ client needs requirements α׷ մϴ.

 


gmpeye 湮 α׷ . . .

湮Ͽ ϹǷ

1. ο ̰

2. ο ⿡ а /亯 ϱ ȿ

3. 庰 needs ֽϴ.


[湮 α׷]

 

1

GMP Basics - GMP Essentials & Key Principles

 

: ü, GMP  ذ ʿ μ(R&D, Sales & Marketing, , μ )

ֿ : GMP , GMP ٽ , Ǿǰ 5 ٽ Ư GMP Ȱ 

ð: 3ð

2

Data Integrity Program: Good Data & Record Management Practices in Production and Quality Control

 

: ü

ֿ : Ģ(ALCOA+) ǰ GMP ϰ ϱ /Ȯ, , , /, ܰ躰

ð: 3~4ð

3

GMP Case Study ø

3-1

GMP Case Study No. 1: GMP ǻ ʸ ֿ GMP

 

: ü

ֿ : ̱ FDA 483 Warning Letter GMP ߽, ֿ GMP ǹ  ؼǰ Ǵ

ð: 3~4ð

3-2

GMP Case Study No. 2: DI(data integrity) GMP ǻ ؼ

 

: ü

ֿ : ̱ FDA 483 Warning Letter DI(data integrity) GMP ǻ ʿ ǹ

ð: 3~4ð

3-3

GMP Case Study No. 3: APS(aseptic process simulation) GMP ǻ ؼ

 

: QA, QC,

ֿ : ̱ FDA 483 Warning Letter APS(aseptic process simulation) GMP ǻ ʿ ǹ

ð: 2~3ð

3-4

GMP Case Study No. 4: PQ(personnel qualification) GMP ǻ ؼ

 

: ü, Ư QA

ֿ : ̱ FDA 483 Warning Letter PQ(personnel qualification: 21 CFR 211.25) GMP ǻ ʿ ǹ

ð: 2~3ð

3-5

GMP Case Study No. 5: Ǿǰ ü GMP ǻ ؼ

 

: ü

ֿ : ̱ FDA GMP ǻ (483 Warning Letter)  Ǿǰ ü GMP ǻ ʿ ǹ

ð: 2~3ð

4

GMP ǻ : 2022 ̱ FDA 483 м ֿ ؼ

 

: ü

ֿ : 2022⿡ ̱ FDA 483 ֱ GMP ǻ ľϰ ָ ʿ䰡 ִ ֿ

ð: 3ð

5

CAPA

 

: ü

ֿ : ǰ ý۰ CAPA (Ż, Ҹ, OOS, ǰ, , ) ȣ 踦 .

ð: 3~4ð

6

Ŭ 븮̼

 

: QA, QC, , ü 븮̼

ֿ : ̱ FDA 븮̼ ̵ΰ EU GMP Annex 15 ݼ/븮̼ ؿ QbD Ŭ 븮̼ ܰ躰

ð: 3ð

7

GMP ýۿ ǰ (Quality Unit) åӰ

 

: ü, Ư QA

ֿ : GMP ý  ־ ǰ (Quality Unit) ϴ ġ å, ֿ Ұ. ǰ /QC/ü ٸ GMP ǰ / ſ ߿ Ͽ .

ð: 3~4ð

8

ֿ ҿ OOS

 

: QC, QA, Ÿ

ֿ : QC ֿ  (ü, þ, þ, ڷ, ) ϰ OOS

ð: 3~4ð

9

Being Audited by [Foreign] Regulatory Authorities or Customers

 

: ü [Ư QA, μ ߰ ̻]

ֿ : ̳ ŷ ü ؾ ܰ躰

ð: 3ð

10

Auditing Vendor/Contractor

 

: QA, ǰü·ü · (, ü , )

ֿ : ǰü·ü ÿ ؾ

ð: 2ð

11

ü/ ݼ

 

: QA, , ü

ֿ : ü/ ݼ (URS, DQ, IQ, OQ) ܰ躰

ð: 6ð

12

QC ü/ ݼ

 

: QA, QC, ü

ֿ : QC ü/ ݼ (URS, DQ, IQ, OQ) ܰ躰

ð: 6ð

13

GMP ý

 

: QA, μ ߰ ̻

ֿ : CGMP ϴ GMP ý , , (, ȣ, ȣ, ȣ ) , ۼ, , , , , ܰ躰

ð: 6ð

14

QA ǹ : ̱ CGMP, EU-PIC/S GMP QA  ֿ ؼ

 

: QA, Ÿ

ֿ : ǰ QA , ֿ QA Ȱ(, 븮̼, , , Ż, ) ̱ GMP ذ GMP, PIC/S GMP ߽

ð: 12ð

15

븮̼: VMP PV

 

: QA, QC, , ü

ֿ : 븮̼ ý ǥ ֿ 븮̼ Ȱ Ģ, 븮̼ ý, 븮̼ (VMP, , ) ۼ, URS ۼ, DQ, IQ, OQ, PQ, PV ܰ躰

ð: 12ð

16

QC ü ݼ򰡿 븮̼

 

: QA, QC, ü

ֿ : QC ü м ݼ(URS, DQ, IQ, OQ, PQ) 븮̼/̼ ܰ躰

ð: 12ð

17

ǰ ý GMP

 

: QA, μ ߰ ̻, SOP ۼ å

ֿ : ǰ ý , Quality Policy SOP, Ÿ GMP 븮̼ , ϼ

ð: 12ð

18

Quality Audit

 

: QA, μ ߰ ̻

ֿ : ϸ鼭 ľϰ ų ִ Quality Audit (ȹ, , м, ) ܰ躰

ð: 12ð

 


 

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