What is the Origin of GDP?

The concept of Good Distribution Practice evolved from the broader Good Manufacturing Practice (GMP) guidelines, extending quality assurance principles beyond the manufacturing floor to the entire distribution network. These regulations were developed by international bodies and adopted by regulatory agencies to address risks associated with storage, transport, and handling of pharmaceuticals. This formalization ensures a consistent standard of quality across global supply chains.

What is the Mechanism of GDP?

GDP mandates rigorous controls over key aspects of the distribution process, including personnel training, proper documentation, facility security, and strict temperature control during storage and transit. A core function is the qualification and continuous monitoring of transportation and storage environments, often utilizing devices to track Mean Kinetic Temperature, ensuring the hormonal product's stability is never compromised before reaching the patient.

GDP ∞ Area

GDP

Meaning

In the pharmaceutical context, GDP stands for Good Distribution Practice, which is a set of quality guidelines governing the wholesale distribution of medicinal products. These guidelines ensure that the quality and integrity of medicines, including temperature-sensitive hormonal preparations, are maintained throughout the entire supply chain, from the manufacturing site to the pharmacy or dispensing unit. Adherence to GDP is paramount for ensuring patient safety and therapeutic efficacy of hormone replacement therapies.