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GMP 교육 / 컨설팅 / GMP 문서 번역

US FDA guidelines

EMA Q-guidelines

Industry Issues: Contamination Control Strategy, Data Integrity, QbD

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

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

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 Produ cts

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 4 - Regulation of Combination Products

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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