Effective sweat management is crucial for the success of medicinal patches, as it impacts both their adhesion and patient safety. Sweat accumulation at the patch-skin interface can compromise therapeutic efficacy by causing the patch to detach prematurely, preventing the release of the required drug dose. Additionally, prolonged moisture can lead to skin maceration, characterized by softening, wrinkling, and increased infection risk. To address these issues, adhesive matrices with materials such as acrylates or hydrocolloids are designed to manage sweat effectively, ensuring adhesion and safety throughout use. These characteristics are rigorously evaluated in clinical tests to meet global health standards, highlighting the importance of proper sweat management in delivering safe, effective, and reliable medicinal patches.

Interchangeability guidances for transdermal systems need harmonization, as the next challenge to add uniformity and scientifical sense to the regulatory process. There are key differences among current guidances for interchangeability of transdermal systems, which could mean that a same clinical study is approved in one region and rejected in another one. The experience gathered till now seems to be enough to start considering a harmonization process.

In the pharmaceutical industry, computerized systems impacting GxP environments must adhere to strict regulations to ensure product quality and patient safety. A documented inventory is essential for controlling these systems, identifying their GxP impact, and assessing their associated risk levels. This inventory supports regulatory compliance, facilitates audits, and enables strategic planning of systems, contributing to transparency and data integrity.