FDA 21 CFR Part 211 establishes several requirements for pharmaceutical manufacturers to ensure the quality, safety, and effectiveness of drug products.
General provision
The general provision section defines the scope of 21 CFR Part 211, stating that it applies to “manufacturing, processing, packing, and holding drug products intended for human use.” In addition, it clarifies that these regulations apply to prescription and over-the-counter drugs, ensuring that all pharmaceutical manufacturers adhere to the same quality standards.
Personnel qualifications
The personnel qualifications section demands that you employ personnel with education, training, and experience in manufacturing and quality control functions. Further, you should define roles and responsibilities and train all personnel on CGMP requirements and their specific tasks.
Facilities and equipment
Pharmaceutical manufacturing facilities must be designed, constructed, and maintained to facilitate proper operations and prevent contamination. Adequate space, lighting, ventilation, and control systems are required. Equipment used in manufacturing, processing, and packaging must be designed appropriately, sized properly, and be capable of ensuring product quality.
Control of components and drug product containers
Procedures must be in place to ensure that all components and containers used in drug product manufacturing are high-quality and meet established specifications. Proper storage, handling, and identification of components is essential to prevent errors, cross-contamination, and deterioration.
Production and process controls
Manufacturers must establish written procedures and controls for the production and processing of drug products. These controls include ensuring accurate weighing and measuring, proper mixing, adequate monitoring of critical parameters, and correct packaging and labeling.
Laboratory controls
Laboratories used for testing and analyzing drugs must follow documented procedures to ensure accurate and reliable results. Additionally, you should establish and follow practices on equipment calibration, method validation, sample handling, and record keeping.
Packaging and labeling controls
Packaging and labeling operations must be performed under written procedures to prevent labeling errors and product contamination. In addition, specifications must be established and followed for clear labeling content, format, and placement.
Holding and distribution
You’ll need procedures to ensure that you’re storing, handling, and distributing drugs under conditions that will maintain their quality and integrity. This includes preventing unauthorized access, contamination, and deterioration during storage and transportation.
Records and documentation
You must maintain detailed records of all manufacturing, processing, packaging, labeling, and testing activities. These records should include information about batch production, testing results, equipment cleaning, calibration, maintenance, distribution, and complaint handling.
Out-of-specification (OOS) investigations
Out-of-specification investigations ensure that any testing or manufacturing results outside established specifications are investigated. The inquiry should identify the root cause of the problem, assess its impact on product quality, and implement corrective and preventive actions.