The pharmaceutical and medical device industry is responsible for producing and distributing life-saving products that are critical to the health and well-being of individuals. However, the effectiveness of the supply chain relies heavily on efficient transportation and logistics management.
Products can be sensitive to temperature, humidity, light and mechanical stress. Any deviation from the required conditions can affect the product’s quality (potency, identity, efficacy and safety). Therefore, it is essential to maintain the integrity of the product throughout the entire transportation process.
SeerPharma has extensive experience auditing warehousing and logistics operations against requirements laid out by companies and GDP regulations.
The following are the typical regulations and standards SeerPharma is requested to audit against:
Regulations and Standards
- PIC/S Guide to Good Distribution Practice for Medicinal Products
- PDA TR 39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Sensitive Medicinal Products Through the Transportation Environment
- PDA TR 52 Guidance for Good Distribution Practices (GDPs) for the Pharmaceutical Supply Chain
Contact us to learn more about our GDP auditing services, or click the below button to learn about our range of GxP auditing services.
