Compatibility
Packaging components that are compatible with a dosage form will not interact sufficiently to cause unacceptable changes in the quality of either the dosage form or the packaging component.
Examples of interactions include loss of potency due to absorption or adsorption of the active drug substance, or degradation of the active drug substance induced by a chemical entity leached from a packaging component; reduction in the concentration of an excipient due to absorption, adsorption or leachable-induced degradation;recipitation;
changes in drug product pH; discoloration of either the dosage form or the packaging component; or increase in brittleness of the packaging component.
Some interactions between a packaging component and dosage form will be detected during qualification studies on the container closure system and its components. Others may not show up except in the stability studies.
Therefore, any change noted during a stability study that may be attributable to interaction between the dosage form and a packaging component should be investigated and appropriate action taken, regardless of whether the stability study is being conducted for an original application,a supplemental application, or as fulfillment of a commitment to conduct postapproval stability studies.