Framework overlap

Does ISO 27019 cover 21 CFR Part 211?

You hold ISO 27019 and have been told to do 21 CFR Part 211. Here is how much overlaps, control by control.

10% of 21 CFR Part 211 you already have

ISO 27019 already covers about 10% of 21 CFR Part 211, leaving 70 of 78 controls as genuinely new work.

Already covered 4 Likely covered 4 New work 70

What is genuinely new work

Nothing in ISO 27019 reaches these. This is the list to scope.

211.100
Written Procedures for Production and Process Control
211.110
Sampling and Testing of In-Process Materials
211.113
Control of Microbiological Contamination
211.122
Materials Examination and Usage Criteria
211.130
Packaging and Labeling Operations
211.142
Warehousing Procedures
211.150
Distribution Procedures
211.165
Testing and Release for Distribution
211.166
Stability Testing
211.180
General Records Requirements
211.192
Production Record Review
211.198
Complaint Files
211.204
Returned Drug Products
211.22
Responsibilities of Quality Control Unit
211.25
Personnel Qualifications
211.28
Personnel Responsibilities and Hygiene
211.42
Design and Construction of Buildings
211.46
Ventilation, Air Filtration, Air Heating and Cooling
211.67
Equipment Cleaning and Maintenance
211.68
Automatic, Mechanical, and Electronic Equipment
211.84
Testing and Approval of Components
CFR211-A-1
Section 211.1 - Scope
CFR211-B-22
Section 211.22 - Responsibilities of Quality Control Unit
CFR211-B-25
Section 211.25 - Personnel Qualifications
CFR211-B-28
Section 211.28 - Personnel Responsibilities
CFR211-B-34
Section 211.34 - Consultants
CFR211-C-42
Section 211.42 - Design and Construction Features
CFR211-C-44
Section 211.44 - Lighting
CFR211-C-46
Section 211.46 - Ventilation, Air Filtration, Air Heating and Cooling
CFR211-C-50
Section 211.50 - Sewage and Refuse
CFR211-C-56
Section 211.56 - Sanitation
CFR211-C-58
Section 211.58 - Maintenance
CFR211-D-63
Section 211.63 - Equipment Design, Size, and Location
CFR211-D-65
Section 211.65 - Equipment Construction
CFR211-D-67
Section 211.67 - Equipment Cleaning and Maintenance
CFR211-D-68
Section 211.68 - Automatic, Mechanical, and Electronic Equipment
CFR211-D-72
Section 211.72 - Filters
CFR211-E-80
Section 211.80 - General Requirements
CFR211-E-82
Section 211.82 - Receipt and Storage of Untested Components
CFR211-E-84
Section 211.84 - Testing and Approval or Rejection of Components
CFR211-E-86
Section 211.86 - Use of Approved Components
CFR211-E-94
Section 211.94 - Drug Product Containers and Closures
CFR211-F-100
Section 211.100 - Written Procedures and Deviations
CFR211-F-101
Section 211.101 - Charge-in of Components
CFR211-F-103
Section 211.103 - Calculation of Yield
CFR211-F-105
Section 211.105 - Equipment Identification
CFR211-F-110
Section 211.110 - Sampling and Testing of In-Process Materials and Drug Products
CFR211-F-111
Section 211.111 - Time Limitations on Production
CFR211-F-115
Section 211.115 - Reprocessing
CFR211-G-132
Section 211.132 - Tamper-Resistant Packaging Requirements
CFR211-G-134
Section 211.134 - Drug Product Inspection
CFR211-G-137
Section 211.137 - Expiration Dating
CFR211-H-142
Section 211.142 - Warehousing Procedures
CFR211-H-150
Section 211.150 - Distribution Procedures
CFR211-I-160
Section 211.160 - General Requirements
CFR211-I-165
Section 211.165 - Testing and Release for Distribution
CFR211-I-166
Section 211.166 - Stability Testing
CFR211-I-167
Section 211.167 - Special Testing Requirements
CFR211-I-170
Section 211.170 - Reserve Samples
CFR211-I-173
Section 211.173 - Laboratory Animals
CFR211-J-180
Section 211.180 - General Requirements
CFR211-J-182
Section 211.182 - Equipment Cleaning and Use Log
CFR211-J-186
Section 211.186 - Master Production and Control Records
CFR211-J-188
Section 211.188 - Batch Production and Control Records
CFR211-J-192
Section 211.192 - Production Record Review
CFR211-J-194
Section 211.194 - Laboratory Records
CFR211-J-196
Section 211.196 - Distribution Records
CFR211-J-198
Section 211.198 - Complaint Files
CFR211-K-204
Section 211.204 - Returned Drug Products
CFR211-K-208
Section 211.208 - Drug Product Salvaging
Show the 8 you already have
CFR211-G-122
Section 211.122 - Materials Examination and Usage Criteria
CFR211-G-125
Section 211.125 - Labeling Issuance
CFR211-G-130
Section 211.130 - Packaging and Labeling Operations
CFR211-J-184
Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records
CFR211-A-3
Section 211.3 - Definitions
CFR211-C-48
Section 211.48 - Plumbing
CFR211-F-113
Section 211.113 - Control of Microbiological Contamination
CFR211-I-176
Section 211.176 - Penicillin Contamination

How this is calculated

Already covered means a mapping runs from a control in ISO 27019 to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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