FDA 21 CFR Part 211.142 Package Testing

FDA 21 CFR part 211.142 package integrity testing is a regulation that governs the handling, storage, and distribution of drug products. This regulation is part of the Current Good Manufacturing Practices (CGMP) regulations, which are designed to ensure that drug products are safe, effective, and of high quality.

The 21 CFR part 211.142 pharma test standard addresses the requirements for the storage and distribution of drug products. The regulation requires that drug products be stored under appropriate conditions to ensure their stability, and that they be distributed in a manner that prevents contamination, deterioration, and damage.

Specific Requirements for Drug Product Storage

This drug packaging regulation establishes several requirements for drug product storage and distribution, including:

• Storage Conditions: The 21 CFR regulation requires manufacturers to store drug products under conditions that preserve stability and prevent deterioration or contamination. These requirements address temperature, humidity, light, and other environmental factors.

• Container and Closure Systems: Container and closure systems must prevent leakage and maintain the integrity of the drug product throughout storage and distribution.

• Distribution Practices: Manufacturers must distribute drug products in a way that prevents contamination, deterioration, and physical damage. Therefore, the regulation includes requirements for packaging, labeling, handling, and transportation.

• Recordkeeping: Manufacturers must maintain records documenting storage dates and locations, product condition, and any deviations from required storage conditions.

Overall, this regulation helps ensure that drug products remain safe, effective, and high quality throughout storage and distribution. Consequently, failing to comply can result in product recalls, legal and financial penalties, regulatory action, and potential harm to patients.

To comply with 21 CFR Part 211.142, manufacturers must take a comprehensive approach to storage and distribution. In addition, they need appropriate facilities and equipment, validated packaging and labeling systems, and processes that continuously monitor and maintain required storage conditions.

Expert 21 CFR Part 211.142 Transportation Testing

Keystone Compliance is recognized as an industry leader in pharma package testing. Our lab features dozens of temperature and humidity chambers of various sizes and capabilities and a full suite of other package testing equipment. We can test packages ranging in sizes of small vials and boxes to multiple oversized pallets.

Contact us to receive a quote on your next pharmaceutical package test program.