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

 


Questions & Answers on CGMP for Drugs

 

ó ũ: CGMP Q&A

 

General Provisions

1.

USP Ģ(<999> ) FDA ̵ ִ°? Ģ ̰, ü κ ޾Ƶ̰ ؾ ϴ°?

2.

FDA ̵ ʾȿ ǰ ϴ°? USP ȿ ؼ?

 

 

Buildings and Facilities

1.

ϽǸ̶ ΰ?

2.

ϽǸ Ǿǰ̶ ΰ?

3.

ϽǸ Ǿǰ Ǵ°?

4.

ϽǸ Ǿǰ Ͽ Ư ִ°?

5.

ҷΰȭ ƴϼ ȭչ(, 2,4,6-tribromoanisole, TBA) Ǿǰ FDA ϴ ΰ?

6.

ҷΰȭ ƴϼ ȭչ ǰ ִ°?

7.

Ǿǰ ҷΰȭ ƴϼ ȭչ ó FDA ľߴ°?

8.

ҷΰȭ ƴϼ ȭչ Ǿǰ Ͽ FDA 䱸ϴ°?

9.

ҷΰȭ ƴϼ ȭչ Ǿǰ ִ ǥ ִ°?

10.

ҷΰȭ ƴϼ ȭչ Ǿǰ ִ°?

 

 

Equipment

1.

 м  ü "ڵ " ž Ǹϰ ִ. ̿ ڵ ü ִ°? ׷ ٸ ؾ ϴ°?

2.

CDER Ǿǰ Ʈ ִ°?

3.

ô ȿ  ÿ   ܷ    TOC ص Ǵ°?

4.

з ȸ簡 ִ. TSB(tryptic soy broth) 0.2 ũ ͷ 迡 ߴ. 縦 ص ѷ ã ߴ. ó ִ°?

5.

ȭչ(, ȭչ, ̼ ȭչ, ฮ Ȱ ū ȭչ) ô 븮̼ ̰ ؾ ϴ°?

6.

Ǿǰ ô 븮̼  ؾ ϴ°?

7.

ΰ ܷ Ǵ ܷ ؾ ϴ°?

8.

ô 븮̼  ޹ħϱ , ǰ  (ô )  ǥ鿡  ܷ ѷ  ʿ䰡 ִ°?

9.

ڷ  ô 븮̼ α׷ ԽѾ ϴ°?

10.

ܷ  ǰ, ޼ ٰŴ ΰ?

11.

Ư (, θƿ 316) ô ɷ ϰ 븮̼ǵǾٸ, 븮̼ ʰ " Ư" ô ٸ ȭչ ִ°?

12.

̸ ô 븮̼  ܷ   Ѱ?

13.

ֻ ý ȯ Ͽ FDA ȣϴ ִ°(, θƿ PVDF)?

 

 

Control of Components and Drug Product Containers and Closures

1.

ġ Ϸϰ ǰ ص Ǵ°?

2.

ü ԰ ˻縦 , , ü ä ִ°?

3.

з ȸ簡 ִ. TSB(tryptic soy broth) 0.2 ũ ͷ 迡 ߴ. 縦 ص ѷ ã ߴ. ó ִ°?

4.

԰к ̳  ̳ʿ ü Ȯ ǽؾ CGMP ؿ ϴ°? ̳ʿ ü ϰ ȥϿ Ȯ ص Ǵ°?

5.

Ǿǰ ϴµ м ?

6.

Ͽ FDA Ư ǻ̳ 䱸ϰų ϴ°?

7.

Ͽ FDA ϴ κ ΰ?

8.

ũ?

9.

԰ ּȭ ?

10.

Ǿǰ ü ּȭ ִ å ִ°?

11.

ҿ뷮  ̾˿ ϴ ֻ  ( )  ʵ ϱ  Ǿǰ ü  ؾ ϴ°?

12.

÷ IV    Ǵ  Ͽ Ư Ǵ  ִ°?

13.

۾  IV    Ѽ  ǰ  ° ǵǴ  ϱ Ͽ IV Ǿǰ ü  ؾ ϴ°?

14.

USP API  ġ USP ׷  м  ؾ ϴ°?

15.

API ԰ݰ USP ؿ ϴ Ȯϴ м å°?

 

 

Production and Process Controls

1.

ǥ ġ ϼ ٸ Ͽ ؾ ϴ°? ֿ 񺰷 "ô " ߰ ϰ Ѵٸ, ̷ " ۷" ǥ ص ?

2.

ü ԰ ˻縦 , , ü ä ִ°?

3.

з ȸ簡 ִ. TSB(tryptic soy broth) 0.2 ũ ͷ 迡 ߴ. 縦 ص ѷ ã ߴ. ó ִ°?

4.

Ϻ ǰ(, transdermal patches) ٸ ǰ ǰ ҷ ó ξ . ׷ ?

5.

ο API Ǵ  Ǿǰ  ϰ ϱ⿡ ռ  븮̼ ġ 3  ؾ ϴ°?

6.

Ǿǰ ϴ ü ISO 14644-1 ISO 14644-2 ٰϿ ü ݼ򰡸 ǽѴٸ, ̴ CGMP ִ°?

7.

2004 FDA "PAT- Ǿǰ , , ǰ  ӿũ" Ͽ,   ȭ   Ȱ ȭϵ ߴ. PAT    ִ°?

8.

PAT Ͽ CDER Ϸ  ؾ ϴ°?

9.

PAT Ͽ CBER Ϸ  ؾ ϴ°?

10.

۾ Ͽ ֱ⸦  ؾ ϴ°? Ϲ ų /۾ 2ȸ ݺؾ Ѵ. ַ̼Ϳ ϴ 쿡 ֱ⸦ ϰ ϴ°?

11.

FDA ܿ ҵ Ǿǰ ϴ ΰ?

12.

CGMP  ü  κ ܿ ҵ ǰ ü  Ǵ°?

13.

ܿ ҵ ̻  ũ ü  ϰ ó  ִ°?

14.

Leptospira ͸ ִ°? ׷ٸ ̻ Ŭ ũ ü  ؾ ϴ°?

15.

FDA ̵ ʾ "и - ȭ ü ä " öȸ ǥߴ. FDA ϱ⿡ ̵ Ǵ ̾°?

16.

и   ü ä뿡  FDA  ׷ Ű °?

17.

и ȥ Ȯϴ δ  ִ°?

18.

  ȭ ü ä뿡  FDA   ΰ?

19.

׹̻  ϴ   񹫱 Ǿǰ , ѻռ   ó ԰ݿ  ʾ 2 ڿ  ؿ ϸ,  Ǿǰ Ʈ  ϰ Ǹص Ǵ°?

20.

񹫱 Ǿǰ ٶ  ̻      ü  ʿ䰡 ִ°? "ٶ "  ǹΰ?

21.

̻  ϴ   Ǿǰ , ġ      ÿ   ǽ ʿ䰡 ִ°?

 

 

Holding and Distribution

1.

̶ ΰ?

2.

FDA  Ǿǰ    ִ°?

3.

OTC Ǿǰ ó Ǿǰ     ޴°?

4.

OTC ǰ ü ǰ  ؾ ϴ°?

5.

  Ʈ  Ʈ Ͽ  ɼ ؾ ϴ°?

6.

 ǰ   Ǵ°?

 

 

Laboratory Controls

1.

 м  ü "ڵ " ž Ǹϰ ִ. ̿ ڵ ü ִ°? ׷ ٸ ؾ ϴ°?

2.

Ǿǰ     ǥü  ִ Ȯ , Ǿǰ    ׻ ؾ ϴ°?

3.

USP <788> LVP ֻ ̸   , ġ ԰  θ ϱ    ǰ հ ϴ ͵ Ǵ°?

4.

ô ȿ  ÿ   ܷ    TOC ص Ǵ°?

5.

Ķ󸶱׳ƽ Ǵ м ġ Ƿ ϴ Ǵ Ҽ ִ°?

6.

2005 5  CPG  480.200(7132b.11)  " 뷮  Ǿǰ ȿ Ⱓ" ٰϿ,  뷮 ⿡      ȿⰣ ִ 12 ο  ִ°?

7.

Ǿǰ ᳪ ǰ 븮̼ǵ     ִ°?

8.

 ֻ Ǿǰ,  ǰ, Ƿ  ǰ   LAL  븮̼ǿ  1987 ̵ öȸߴ°?

9.

 迡      ִ°?

10.

ϽǸ  Ǿǰ ϽǸ Ǿ ɼ , ϽǸ ǰ Ͽ ϽǸ ܷ  ʾҴٸ,  ǰ ص Ǵ°?

11.

ϽǸ   ߴ ü   óϰ   ϽǸ ǰ ص Ǵ°?  ü ϽǸ ǰ  ̻  ʴ´.

12.

ϽǸ Ǿǰ  ϽǸ ܷ    ִ°?

13.

ȸ  ֻ Ǿǰ 쿡 ȸ  뷮 ̾Ƴ  ϴ Ƚ ȿⰣ  ÿ ؾ    ΰ?

14.

    ǰ и  м⹰,  緿/,  ھ 󸶳     Ǿǰ    ִ°?

15.

ũθ׷ ý ġ ǥǰ  ִ°?

16.

ý ռ 迡  ִ°?

17.

ü "ù " Ѱ?

 

 

Records and Reports

1.

Ϻ ǰ(, transdermal patches) ٸ ǰ ǰ ҷ ó ξ . ׷ ?

2.

ġ Ϸϰ   ǰ   ص Ǵ°?

3.

Ǿǰ   迡 Ǵ ǻȭ  ýۿ    ϼ  ũθ׷ μ⹰ Ʈ 11  " Ģ "(21 CFR Ʈ 211) Ǵ°?

4.

ȭй, þ, , ȿ Ⱓ (21 CFR Ʈ 211) FDA ؼϴ°?

 

 

Returned and Salvaged Drug Products

1.

ڿ ظ  Ͱ    ǿ Ǿ Ǿǰ̳ Ḧ  óؾ ϴ°?

2.

 ǿ   缱  ԵǴ°?

3.

Ǿǰ̳ Ǿǰ  Ǵ  簡 缺  Ǿ     ؾ ϴ°?

 

 

 

 


 

 

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