GDP

That definition is taken from the EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01), which are based on Article 84 and Article 85b(3) of Directive 2001/83/EC.

The guidelines state that, under Article 80(g) of the directive, distributors holding a wholesale distribution authorisation must comply with GDP. So must manufacturers performing any distribution activities with their own products. People brokering medicinal products must be subject to certain provisions applicable to wholesale distributors. Other parties involved in distribution should also adhere to relevant sections, though the guidelines do not name those sections. According to the PIC/S guidance PIC/S PIC/S, the Pharmaceutical Inspection Co-operation Scheme, describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicines. Read in the glossary → document PI 011-3, GDP sets out which compliance requirements apply to wholesaling and distribution.

For software, the passage that matters is section 3.3.1 on computerised systems. It says that before such a system is brought into use, appropriate validation Validation In the EU GMP and GDP glossaries, validation is the action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results. Read in the glossary → or verification studies should demonstrate that it is capable of achieving the desired results accurately, consistently and reproducibly.

For more than ten years we have worked with a pharma logistics provider Pharma logistics Pharma logistics is the term we use for storing, transporting and delivering medicinal products and other pharma-sector goods, such as promotional material and supplies for patients. Read in the glossary → whose work is shaped by GDP, developing and maintaining business applications Business application In general terms, a business application is software used to perform or support business functions. Read in the glossary → for its own use and for its clients, the pharma companies it serves. Where our case studies cite GDP sections, they do so as further reading, not as a statement about the software described.