21 CFR Part 211: every control, and what you already have

78 controls 210 frameworks share controls with it United States verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

21 CFR Part 211 Pharmaceutical cGMP Evidence & Implementation Kit

78 controls is the documentation set somebody has to write. This is that set, already written: an adopt-ready artifact for every control in policy and procedure text you edit rather than draft, and the evidence checklist an auditor asks for against each.

See what is in it, $249

The same set every buyer of this kit receives. Nothing here is produced on request.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you run	Shared controls
21 CFR Part 58	16	measure it →
FDA Quality Management System Regulation (QMSR)	8	measure it →
ISO 15189:2022	5	measure it →
PIC/S Guide to Good Manufacturing Practice for Medicinal Products	5	measure it →
Protective Security Policy Framework (PSPF) Release 2024	5	measure it →
Singapore Government Instruction Manual on ICT&SS Management (IM8)	5	measure it →
ICH E6(R3)	4	measure it →
IEC 60601-1	4	measure it →
IEC 62304:2015 Medical Device Software Lifecycle Processes	4	measure it →
ISMAP (Japan)	4	measure it →
ISO 14064	4	measure it →
ISO 27017	4	measure it →

Every control

Code	Control	Also in
`211.100`	Written Procedures for Production and Process Control	1
`211.110`	Sampling and Testing of In-Process Materials	0
`211.113`	Control of Microbiological Contamination	0
`211.122`	Materials Examination and Usage Criteria	1
`211.130`	Packaging and Labeling Operations	0
`211.142`	Warehousing Procedures	1
`211.150`	Distribution Procedures	0
`211.165`	Testing and Release for Distribution	0
`211.166`	Stability Testing	0
`211.180`	General Records Requirements	1
`211.192`	Production Record Review	1
`211.198`	Complaint Files	0
`211.204`	Returned Drug Products	0
`211.22`	Responsibilities of Quality Control Unit	1
`211.25`	Personnel Qualifications	1
`211.28`	Personnel Responsibilities and Hygiene	1
`211.42`	Design and Construction of Buildings	1
`211.46`	Ventilation, Air Filtration, Air Heating and Cooling	0
`211.67`	Equipment Cleaning and Maintenance	1
`211.68`	Automatic, Mechanical, and Electronic Equipment	1
`211.84`	Testing and Approval of Components	1
`CFR211-A-1`	Section 211.1 - Scope	0
`CFR211-A-3`	Section 211.3 - Definitions	157
`CFR211-B-22`	Section 211.22 - Responsibilities of Quality Control Unit	0
`CFR211-B-25`	Section 211.25 - Personnel Qualifications	0
`CFR211-B-28`	Section 211.28 - Personnel Responsibilities	0
`CFR211-B-34`	Section 211.34 - Consultants	0
`CFR211-C-42`	Section 211.42 - Design and Construction Features	0
`CFR211-C-44`	Section 211.44 - Lighting	0
`CFR211-C-46`	Section 211.46 - Ventilation, Air Filtration, Air Heating and Cooling	0
`CFR211-C-48`	Section 211.48 - Plumbing	15
`CFR211-C-50`	Section 211.50 - Sewage and Refuse	0
`CFR211-C-56`	Section 211.56 - Sanitation	0
`CFR211-C-58`	Section 211.58 - Maintenance	0
`CFR211-D-63`	Section 211.63 - Equipment Design, Size, and Location	0
`CFR211-D-65`	Section 211.65 - Equipment Construction	0
`CFR211-D-67`	Section 211.67 - Equipment Cleaning and Maintenance	0
`CFR211-D-68`	Section 211.68 - Automatic, Mechanical, and Electronic Equipment	0
`CFR211-D-72`	Section 211.72 - Filters	0
`CFR211-E-80`	Section 211.80 - General Requirements	0
`CFR211-E-82`	Section 211.82 - Receipt and Storage of Untested Components	0
`CFR211-E-84`	Section 211.84 - Testing and Approval or Rejection of Components	0
`CFR211-E-86`	Section 211.86 - Use of Approved Components	0
`CFR211-E-94`	Section 211.94 - Drug Product Containers and Closures	0
`CFR211-F-100`	Section 211.100 - Written Procedures and Deviations	0
`CFR211-F-101`	Section 211.101 - Charge-in of Components	0
`CFR211-F-103`	Section 211.103 - Calculation of Yield	0
`CFR211-F-105`	Section 211.105 - Equipment Identification	0
`CFR211-F-110`	Section 211.110 - Sampling and Testing of In-Process Materials and Drug Products	0
`CFR211-F-111`	Section 211.111 - Time Limitations on Production	0
`CFR211-F-113`	Section 211.113 - Control of Microbiological Contamination	15
`CFR211-F-115`	Section 211.115 - Reprocessing	0
`CFR211-G-122`	Section 211.122 - Materials Examination and Usage Criteria	49
`CFR211-G-125`	Section 211.125 - Labeling Issuance	49
`CFR211-G-130`	Section 211.130 - Packaging and Labeling Operations	49
`CFR211-G-132`	Section 211.132 - Tamper-Resistant Packaging Requirements	0
`CFR211-G-134`	Section 211.134 - Drug Product Inspection	0
`CFR211-G-137`	Section 211.137 - Expiration Dating	0
`CFR211-H-142`	Section 211.142 - Warehousing Procedures	0
`CFR211-H-150`	Section 211.150 - Distribution Procedures	0
`CFR211-I-160`	Section 211.160 - General Requirements	0
`CFR211-I-165`	Section 211.165 - Testing and Release for Distribution	0
`CFR211-I-166`	Section 211.166 - Stability Testing	0
`CFR211-I-167`	Section 211.167 - Special Testing Requirements	0
`CFR211-I-170`	Section 211.170 - Reserve Samples	0
`CFR211-I-173`	Section 211.173 - Laboratory Animals	0
`CFR211-I-176`	Section 211.176 - Penicillin Contamination	15
`CFR211-J-180`	Section 211.180 - General Requirements	0
`CFR211-J-182`	Section 211.182 - Equipment Cleaning and Use Log	0
`CFR211-J-184`	Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records	68
`CFR211-J-186`	Section 211.186 - Master Production and Control Records	0
`CFR211-J-188`	Section 211.188 - Batch Production and Control Records	0
`CFR211-J-192`	Section 211.192 - Production Record Review	0
`CFR211-J-194`	Section 211.194 - Laboratory Records	0
`CFR211-J-196`	Section 211.196 - Distribution Records	0
`CFR211-J-198`	Section 211.198 - Complaint Files	0
`CFR211-K-204`	Section 211.204 - Returned Drug Products	0
`CFR211-K-208`	Section 211.208 - Drug Product Salvaging	0

Tell me when 21 CFR Part 211 files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What an auditor will ask you to produce

The artefacts named on the failure modes this framework speaks to.

Complaint trend analysis
Complaints procedure
Complaints register with categories
Investigation and response records
Complaint handling SOP
Complaint intake and triage records
Sampling procedure and plan
Sampling records linked to items
Deviation records during sampling
Sampling competence evidence

How programmes fail on this

Failure modes named by this framework and others. Each opens the full record.

Trends not reviewed in management review named by 3 frameworks
Sampling plan not statistically justified named by 3 frameworks
Sampling not representative named by 3 frameworks

What this page is

A control-level reference for 21 CFR Part 211, drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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