Stability data aren’t only essential in ensuring effective drug substance and product fabrication, since the supply chain for medicinal products and materials is itself highly controlled, with SOPs giving advice regarding the processes to be followed. Qualified equipment has to be used for transportation too. Evidently, during fabrication, the monitoring and control of manufacturing steps and process conditions is controlled, and any deviations from standards registered and assessed; constant improvement is a natural effect of such activities. When transporting medication material, nevertheless, it needs to be determined whether there is a risk for chemical or product stability, and together with the API, excipient quality and stability also has to be taken under account.
Drug substance stability needs to be considered through the drug development process, in the pre-clinical stage to final product acceptance. Analytical development, forced degradation studies and majority API stability studies form the basis of pre-clinical work, with Phase I research covering additional analytical development and method validation, first formulation stability studies, and stress tests. For container characterization, extractables studies need to be carried out so as to detect potential dangers of chemicals leaching into the product, and help to decide on the best container material. Normal studies performed in Stage II and III include comparator release and stability studies, through to in-use and compatibility studies to enrolment stability and the conclusion of final method validation. Phases II and III are also the phases in which transport stability studies should take place. At length, after market acceptance, certain leachable studies and follow-up stability tests are performed.
Apparently, the stability of goods need to be Stability Testing under different conditions based on where the item is to be sent. Because of high variations over climatic zones, transport simulation studies will need to be accommodated to ensure quality of drug products and drug substances reflect local market equilibrium requirements. The World Health Organization describes four climatic zones — temperate, subtropical and Mediterranean, hot and dry and humid and hot. It has to be conscious of mechanical influences like pressure variation, vibrations, and physical effects, and climatic influences like temperature variation, light and humidity. Chemical influences contain gases and cross-contamination by other products, while biological influences include microbial contamination and insect infiltration. Criminal factors also need to be considered, such as manipulation of products and burglary.