The WHO is look­ing for com­ment on its pro­pos­al to com­bine the fea­tures of good stor­age and dis­tri­b­u­tion for med­ical prod­ucts into a sin­gle guid­ance doc­u­ment and will be applic­a­ble to indi­vid­u­als and out­lets involved in stor­ing and dis­trib­ut­ing med­ical products.

It is rel­e­vant in every stage of the sup­ply chain from man­u­fac­ture to administration.

When com­plet­ed, it will be valid for all med­ical prod­ucts that patients can obtain with or with­out a pre­scrip­tion, includ­ing drugs, bio­log­i­cals, vac­cines and med­ical devices. It is rel­e­vant in every stage of the sup­ply chain from man­u­fac­ture to admin­is­tra­tion. Par­tic­u­lar sec­tions of the guide­line may also be employed, by gov­ern­ments, reg­u­la­to­ry bod­ies, inter­na­tion­al pur­chas­ing organ­i­sa­tions, donor agen­cies cer­ti­fy­ing groups, health­care employ­ees and any oth­er peo­ple involved in the sup­ply chain.

The organ­i­sa­tion advis­es on how the dif­fer­ent stake­hold­ers can exe­cute their respon­si­bil­i­ties and evade the intro­duc­tion of infe­ri­or and unre­li­able prod­ucts into the mar­ket. It believes that the prin­ci­ples of good stor­age and dis­tri­b­u­tion prac­tices should be incor­po­rat­ed in nation­al law. The guide­line gives advice on, among oth­er top­ics, qual­i­ty man­age­ment, com­plaint man­age­ment, stock con­trol, per­son­nel, main­tain­ing doc­u­men­ta­tion and inspec­tion of stor­age and dis­tri­b­u­tion facilities.

The final guid­ance should be pre­sent­ed for adop­tion at the WHO’s Expert Com­mit­tee on Spec­i­fi­ca­tions for Phar­ma­ceu­ti­cal Prepa­ra­tions next meet­ing in October. 

Source: Medtech Insight (an Infor­ma product)