By Erica Stolz

The International Society for Pharmaceutical Engineering (ISPE) recently published a new Packaging Validation Discussion Paper.  The paper is intended to help bridge a gap spanning between manufacturing process validation and packaging process validation.  Unlike commissioning and qualification (C&Q), packaging process validation aims to provide a high level of assurance that the packaging process produces product meeting all acceptance criteria specified for it.  A high level of assurance is demonstrated through longer-term statistical analyses such as statistical process control (charting) of critical process parameters and process capability analyses.  Packaging process validation considers not just risk to the product, but risk to the patient as well.

If you are interested in learning more about how packaging validation may be approached using tools already available industry-wide, click here and select the discussion paper “Overview of Packaging Validation for Drug Products.”  ISPE membership is not necessary to access the paper.  Seasoned packaging validation professionals are also encouraged to review and provide feedback on the contents of the paper by submitting all comments or questions to  Be sure to reference the title of the paper, when submitting feedback.

With further demands for drug package serialization, a requirement of the United States Drug Supply Chain Security Act, the timing of this paper could not be more critical.  A basic understanding of requirements for successful packaging validation of primary, secondary, and tertiary packaging is paramount.

Clarke Solutions can provide customized packaging validation services to your business.  For more information, contact a member of our team for a free consultation.