There are numerous regulations and guidance documents governing drug product labeling intended to guarantee label process validation according to regulations laid out in US 21 CFR Part 11. Critical factors such as materials of use, especially around adhesives, readability and accuracy of content, adhesion of label to its assigned package system, and potential migration of label materials to leach or contaminate the drug product or device must be addressed. As this is a frontline issue impacting patient and end user safety, the FDA and EU are consistently addressing label issues as part of their normal inspection and review process.
There are no defined set standards or published test methods that universally address label qualification issues across the drug product or medical device industries. Due to the uniqueness of not only the various drug products and devices, but also their package systems, test strategies must be developed on a company-to-company and product-to-product basis.
As part of its Comprehensive and Complimentary Service offering, the CS Analytical Team has the experience and knowledge to assist with label compliance requirements. The service offering specific to label issues includes:
- Development of a Comprehensive Test Plan
- Formal Test Protocol Development
- Validation of Test Methods
Common Tests Performed by the CS Analytical Laboratory staff specific to label issues:
Label Adhesion Studies
Protocol driven, this test program typically subjects the labeled package system to varying environmental stressors for defined time periods and is intended to evaluate label adhesion consistency over time.
Typically using a Mil Spec defined sample set based upon total production units, the objective of this type of study is to ensure accuracy and readability of printed materials on the label.
Adhesive Migration Studies
Designed to evaluate the potential for substrates of the adhesive chemicals to extract and leach into the container interior thus impacting or degrading actual drug product.
Ink Migration Studies
Similar to Adhesive Migration Studies, ink migration studies can be developed and performed to ensure that ink materials are not impacting the package drug product or device.