Pharmaceutical Package Integrity Testing

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.

This drug packaging regulation sets forth several specific requirements for drug product storage and distribution including:

Storage conditions: The 21 CFR regulation requires that drug products be stored under conditions that ensure their stability. Specific storage conditions also protect them from deterioration or contamination. This includes requirements for temperature, humidity, light, and other environmental factors.

Container and closure systems: The container and closure systems must be designed to prevent leakage. Enclosures must assist in maintaining the integrity of the drug product.

Distribution practices: Drug products must be distributed in a manner that prevents contamination, deterioration, and damage including requirements for packaging, labeling, and handling of the drug products during transportation.

Recordkeeping: Records must be kept that include information on the date and location of storage, the condition of the drug product, and any deviations from the required storage conditions.

This packaging test standard helps determine if drug products are stored and distributed in a manner that maintains their quality and safety. Failure to comply with this regulation can lead to serious consequences, including product recalls, legal and financial penalties, and harm to patients.

Compliance with the 21 CFR part 211.142 transportation testing standard requires a comprehensive approach to drug product storage and distribution. This includes proper facilities and equipment for storage, appropriate packaging and labeling for transportation, and a system for monitoring and maintaining the 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.