The pharmaceutical quality of medicinal products is of utmost importance to patient health and outcome: poor quality can lead to adverse effects - which can sometimes be severe enough to lead to morbidity and death, as well as treatment failure and hence, prolonged illness, lack of trust in the healthcare system, distributor and manufacturer, and a waste of financial resources.
What is a quality medicine? High quality medicines comply with offcial standards for strength, purity, identity, effcacy, packaging and labelling. They are safe, free from contamination and protected against temperature extremes and tampering from the point of manufacture, throughout the distribution chain and eventual administration to the patient.
The pharmaceutical supply chain has stretched around the world to the remotest, previously inaccessible places, and so has the presence of substandard (products that have been improperly produced, handled or stored) and counterfeit products (products whose identity, strength or source have been deliberately tampered with). Good distribution practice (GDP) refers to all the activities designed and implemented to ensure that the high quality levels achieved during the manufacture of medicines are maintained at every point throughout the distribution chain from manufacturer to patient, and ensuring compliance with regulatory requirements at all stages. All patients would like to be certain that the excellent quality under which medicines are made in the manufacturing industry has been maintained all along the legitimate supply chain and that they are always safe. This is particularly true for time-and-temperature-sensitive pharmaceutical products. The biggest issue facing the pharmaceutical industry is temperature control because the pharmaceutical supply chain is becoming very complex, involving a number of different storage and transit locations that include airports and docks.