21 CFR Part 211.94 Specific to Drug Product Containers and Closures clearly outlines the following requirements:

  • Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.
  • Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
  • Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
  • Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures.

The FDA’s 1994 Guidance for Industry for the Submission of Sterilization Process Validation in Applications for Human and Veterinary Drug Products requires that companies / manufacturers evaluate the tests and studies performed to ensure and demonstrate that the containers and associated package system for all drug product meets qualification requirements outlined as follows:

  • Verify that all incoming container-closure components meet specifications, including all appropriate dimensions.
  • Ensure qualification studies adequately simulate the stress conditions of the sterilization process, handling and storage.
  • Verify that the units tested in validation are appropriate for drug product and package system intended use.
  • Sensitivity of the test program implemented is specified.
  • Container-closure integrity is demonstrated during validation and as part of the stability program (in lieu of sterility testing) over the shelf life of the product.

The ultimate and required goal of an effective container and package system qualification testing program is demonstration that the system is suitable for its intended use, avoiding the receipt of an FDA generated warning letter that opens with the following sentence:

“Your firm failed to ensure your container and/or package system provided adequate protection against foreseeable factors in storage and use that can cause deterioration or contamination of the drug product”.

The CS Analytical Team of Experts is committed to assisting and ensuring that you understand and meet the strict regulatory requirements when it comes to your container and package system testing needs. We possess the experience, regulatory knowledge and cGMP laboratory facilities and instrumentation to ensure that all of your container and package system requirements will be met.