21 CFR Part 111 – The Skalli Group

Overview

21 CFR Part 111 is the FDA’s regulation establishing Current Good Manufacturing Practices (cGMPs) for dietary supplements. It outlines specific requirements for manufacturing, packaging, labeling, and holding operations to ensure product quality, identity, purity, strength, and composition.

General Provisions

Establishes scope, definitions, and applicability of Part 111.
Details roles and responsibilities within the organization regarding compliance.

Personnel

Personnel must have education, training, or experience to perform assigned functions.
Personal hygiene practices must be maintained to prevent contamination.

Physical Plant and Grounds

Facilities must be of suitable size, design, and construction.
Prevent pest contamination, ensure sanitation, and manage waste.

Equipment and Utensils

Equipment must be appropriately designed, maintained, and cleaned.
Calibration and maintenance logs must be retained.

Requirements for Components, Packaging, and Labels

Identity testing of all incoming dietary ingredients.
Establish written specifications for each component used.

Production and Process Control System

Requires Master Manufacturing Records (MMRs) and Batch Production Records (BPRs).
In-process specifications and controls must be implemented.

Packaging and Labeling Control System

Prevent mislabeling and ensure proper label reconciliation.
Finished product labels must meet established specifications.

Holding and Distribution

Storage must prevent contamination and deterioration.
Procedures for transportation must ensure product integrity.

Returned Products

Evaluate returned products to determine if they may be salvaged or destroyed.
Prevent re-entry of unsafe products into the market.

Product Complaints

Establish a product complaint handling system.
Investigate complaints and maintain documentation for FDA review.

Records and Recordkeeping

Maintain documentation for all activities required by Part 111.
Retain records for 1 year past product expiration or 2 years beyond distribution.