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

 


US FDA CGMP

 

21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (as of March 30, 2017)

 

210.1  Status of current good manufacturing practice regulations

210.2  Applicability of current good manufacturing practice regulations

210.3  Definitions

 

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (as of March 30, 2017)

Subpart A

General Provisions

Subpart B

Organization and Personnel

Subpart C

Buildings and Facilities

Subpart D

Equipment

Subpart E

Control of Components and Drug Product Containers and Closures

Subpart F

Production and Process Controls

Subpart G

Packaging and Labeling Control

Subpart H

Holding and Distribution

Subpart I

Laboratory Controls

Subpart J

Records and Reports

Subpart K

Returned and Salvaged Drug Products

 

Preamble to Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs (1978)

 

Summary

Chapter 1

General Comments

Chapter 7

Definitions

Chapter 8

Organization and Personnel

Chapter 9

Buildings and Facilities

Chapter 10

Equipment

Chapter 11

Control of Components and Drug Product Containers and Closures

Chapter 12

Production and Process Controls

Chapter 13

Packaging and Labeling Control

Chapter 14

Holding and Distribution

Chapter 15

Laboratory Controls

Chapter 16

Records and Reports

Chapter 17

Returned and Salvaged Drug Products

 

Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule (Federal Register: September 8, 2008: Volume 73, Number 174)

 

Questions & Answers on CGMP for Drugs

 

21 CFR Part 11 - Electronic Records; Electronic Signatures

 

Preamble to 21 CFR Part 11

 

Summary

Chapter 1

Background

Chapter 2

Highlights of the Final Rule

Chapter 3

Comments on the Proposed Rule

Chapter 4

Scope

Chapter 5

Implementation

Chapter 6

Definitions

Chapter 7

Electronic Records - Controls for Closed Systems

Chapter 8

Electronic Records - Controls for Open Systems

Chapter 9

Electronic Records - Signature Manifestations

Chapter 10

Electronic Records - Signature/Record Linking

Chapter 11

Electronic Signatures - General Requirements

Chapter 12

Electronic Signature - Components and Controls

Chapter 13

Electronic Signatures - Controls for Identification Codes/Passwords

 

21 CFR Part 820 - Quality System Regulation (for Medical Devices)

 

Preamble to 21 CFR Part 820

 

Summary & Supplementary Information

Subpart A

General Provisions

Subpart B

Quality System Requirements

Subpart C

Design Controls

Subpart D

Document Controls

Subpart E

Purchasing Controls

Subpart F

Identification & Traceability

Subpart G

Production & Process Controls

Subpart H

Acceptance Activities

Subpart I

Nonconforming Product

Subpart J

Corrective and Preventive Action

Subpart K

Labeling and Packaging Control

Subpart L

Handling, Storage, Distribution, and Installation

Subpart M

Records

Subpart N

Servicing

 
 

 


 

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