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Electronic Code of Federal Regulations

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e-CFR Data is current as of August 28, 2014

Title 21Chapter ISubchapter CPart 211


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER C—DRUGS: GENERAL

PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

rule

Subpart A—GENERAL PROVISIONS

§211.1
Scope.
§211.3
Definitions.
rule

Subpart B—ORGANIZATION AND PERSONNEL

§211.22
Responsibilities of quality control unit.
§211.25
Personnel qualifications.
§211.28
Personnel responsibilities.
§211.34
Consultants.
rule

Subpart C—BUILDINGS AND FACILITIES

§211.42
Design and construction features.
§211.44
Lighting.
§211.46
Ventilation, air filtration, air heating and cooling.
§211.48
Plumbing.
§211.50
Sewage and refuse.
§211.52
Washing and toilet facilities.
§211.56
Sanitation.
§211.58
Maintenance.
rule

Subpart D—EQUIPMENT

§211.63
Equipment design, size, and location.
§211.65
Equipment construction.
§211.67
Equipment cleaning and maintenance.
§211.68
Automatic, mechanical, and electronic equipment.
§211.72
Filters.
rule

Subpart E—CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES

§211.80
General requirements.
§211.82
Receipt and storage of untested components, drug product containers, and closures.
§211.84
Testing and approval or rejection of components, drug product containers, and closures.
§211.86
Use of approved components, drug product containers, and closures.
§211.87
Retesting of approved components, drug product containers, and closures.
§211.89
Rejected components, drug product containers, and closures.
§211.94
Drug product containers and closures.
rule

Subpart F—PRODUCTION AND PROCESS CONTROLS

§211.100
Written procedures; deviations.
§211.101
Charge-in of components.
§211.103
Calculation of yield.
§211.105
Equipment identification.
§211.110
Sampling and testing of in-process materials and drug products.
§211.111
Time limitations on production.
§211.113
Control of microbiological contamination.
§211.115
Reprocessing.
rule

Subpart G—PACKAGING AND LABELING CONTROL

§211.122
Materials examination and usage criteria.
§211.125
Labeling issuance.
§211.130
Packaging and labeling operations.
§211.132
Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
§211.134
Drug product inspection.
§211.137
Expiration dating.
rule

Subpart H—HOLDING AND DISTRIBUTION

§211.142
Warehousing procedures.
§211.150
Distribution procedures.
rule

Subpart I—LABORATORY CONTROLS

§211.160
General requirements.
§211.165
Testing and release for distribution.
§211.166
Stability testing.
§211.167
Special testing requirements.
§211.170
Reserve samples.
§211.173
Laboratory animals.
§211.176
Penicillin contamination.
rule

Subpart J—RECORDS AND REPORTS

§211.180
General requirements.
§211.182
Equipment cleaning and use log.
§211.184
Component, drug product container, closure, and labeling records.
§211.186
Master production and control records.
§211.188
Batch production and control records.
§211.192
Production record review.
§211.194
Laboratory records.
§211.196
Distribution records.
§211.198
Complaint files.
rule

Subpart K—RETURNED AND SALVAGED DRUG PRODUCTS

§211.204
Returned drug products.
§211.208
Drug product salvaging.


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