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21 CFR 211.56 - Sanitation

(a) 

Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.

(b) 

There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.

(c) 

There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).

(d) 

Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations.

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Signify helps regulatory and product compliance teams in CPG and durables manufacturing launch products faster by automating global compliance.

Signify is the leading compliance system for consumer products—leveraging AI agents to automate gap analysis, streamline conformity checks, and accelerate safe, high-quality product launches.

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21 CFR

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© 2025 Signify Technologies, Corp.

Compliance AI Agents

for consumer products

Signify helps regulatory and product compliance teams in CPG and durables manufacturing launch products faster by automating global compliance.

Signify is the leading compliance system for consumer products—leveraging AI agents to automate gap analysis, streamline conformity checks, and accelerate safe, high-quality product launches.

Signify SOC2 Type 2 Compliant

© 2025 Signify Technologies, Corp.

Use Cases

Supplier Check

Labeling

Internal Audits

Quality & Safety

Import & Export

Resources

Blog

Guides

Why Now

21 CFR

Company

About Us

Terms of Service

Privacy Policy

DPA

Compliance AI Agents

for consumer products

Signify helps regulatory and product compliance teams in CPG and durables manufacturing launch products faster by automating global compliance.

Signify is the leading compliance system for consumer products—leveraging AI agents to automate gap analysis, streamline conformity checks, and accelerate safe, high-quality product launches.

Use Cases

Supplier Check

Labeling

Internal Audits

Quality & Safety

Import & Export

Resources

Blog

Guides

Why Now

21 CFR

Company

About Us

Terms of Service

Privacy Policy

DPA

Signify SOC2 Type 2 Compliant

© 2025 Signify Technologies, Corp.