Frequently Asked Questions: 21 CFR Part 211
What is 21 CFR Part 211?
21 CFR Part 211 is a common way to refer to the U.S. Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. Also known as cGMP, it is the primary standard outlining the steps for meeting minimum good manufacturing practice (GMP) standards for finished pharmaceuticals in the United States.
What is 21 CRF Part 210?
FDA 21 CFR Part 210 is used in conjunction with Part 211. Where Part 211 focuses on process control for finished pharmaceuticals, Part 210 outlines minimum standards for manufacturing, facilities and controls.
Why is 21 CFR Part 211 Important?
The goal of 21 CFR Part 211 is to protect consumers by establishing a quality management system that pharmaceutical companies must follow to demonstrate the integrity of drug manufacturing from beginning to end. Being able to meet its standards is required for FDA approval, with the goal of assuring that “the drug products have the identity, strength, quality, and purity they purport.”
What are the key requirements of FDA CFR Part 211?
Meeting the FDA standards for pharmaceutical manufacturing is a complex endeavor, but the major elements involve:
- Qualifications and skills of personnel
- Equipment and facilities maintenance
- Control of components, product containers and closures
- Production and process controls
- Packaging and labeling controls
- Warehousing and distribution
- Laboratory controls
- Records and reports
- Returned and salvaged drug handling procedures
Is FDA 21 CFR Part 211 compliance mandatory?
Compliance with 21 CFR Part 211 is mandatory for pharmaceutical companies operating in the United States and is enforced by the FDA through inspections and audits of manufacturing facilities. Noncompliance can lead to severe consequences, including warning letters, product seizures, recalls, import bans and criminal charges.
How do I get started with FDA 21 CRF 211 compliance?
Quality Management System (QMS) software can streamline and centralize pharmaceutical compliance, improving quality and speeding delivery to consumers. QT9 QMS is a highly rated solution, with 23+ standard modules, including risk management, document control, employee training and audit management, backed by full customer support, an available ERP integration and Business Intelligence tool.
