Fer­ry­ing medicines & sav­ing lives

Pro­duc­ing medicine is only the first step, procur­ing it to the re­quired ar­eas is a highly com­plex trans­port ef­fort, where lives can be at stake if any­thing works less than per­fectly. We seek ex­pert views on how main­tain­ing a phar­ma­ceu­ti­cal lo­gis­tics is se

Cargo Talk - - Contents - Kal­pana Lo­humi

Lo­gis­tics of phar­ma­ceu­ti­cals is not only a com­plex, but de­mand­ing and of­ten chal­leng­ing, as tem­per­a­ture is a vi­tal com­po­nent that needs to be main­tained con­stant. It is cru­cial to as­sure the prod­uct’s in­tegrity at ev­ery point.

ex­plores the dis­tri­bu­tion prac­tices for main­tain­ing qual­ity and prod­uct in­tegrity of tem­per­a­ture-sen­si­tive phar­ma­ceu­ti­cal prod­ucts to achieve end-to-end vis­i­bil­ity. We also delve into com­pli­ance of cer­ti­fi­ca­tions like IATA CEIV Pharma (the Cen­tre of Ex­cel­lence for In­de­pen­dent Val­ida­tors in Phar­ma­ceu­ti­cal Lo­gis­tics) and good dis­tri­bu­tion prac­tices that will help stake­hold­ers in han­dling phar­ma­ceu­ti­cals holis­ti­cally.

FIRST EX­PIRY, FIRST OUT

Vaib­hav Vohra, Man­ag­ing Di­rec­tor, Con­ti­nen­tal Car­ri­ers, be­lieves, “Since the pharma prod­ucts are highly sen­si­tive to heat, hu­mid­ity, di­rect sun­light and other ex­ter­nal fac­tors damp­en­ing the qual­ity, the han­dling in­struc­tions needs to be ex­plic­itly men­tioned on the prod­ucts or pack­ing ma­te­rial while trans­port­ing the goods. At­ten­tion should be paid to prod­ucts re­quir­ing spe­cific stor­age con­di­tions and the stock should be ro­tated

ac­cord­ing to the ‘First Ex­piry, First Out’ (FEFO) prin­ci­ple to main­tain the sanc­tity of the prod­uct.” Shar­ing his ex­pe­ri­ence, he in­forms, “Ap­pro­pri­ate tem­per­a­ture for medic­i­nal prod­ucts should be main­tained dur­ing the trans­porta­tion and stor­age of the goods as de­scribed by the man­u­fac­tur­ers or ship­per. The han­dling of the goods must be in a spe­cific way so that the la­belling is not lost, suf­fi­cient safe­guards against leak­age, theft, break­age, etc. ex­ists along with the record­ing/con­trol­ling fa­cil­i­ties of the crit­i­cal pa­ram­e­ters per­tain­ing to each ship­ment.”

Ra­hat Sachdeva, Vice Pres­i­dent, Ra­hat Con­ti­nen­tal, men­tions four prac­tices that play a ma­jor role in ef­fec­tive dis­tri­bu­tion of tem­per­a­ture-sen­si­tive phar­ma­ceu­ti­cal prod­ucts, i.e. ap­pro­pri­ate pack­ing, mov­ing through the chain, keep­ing track to stay on track and get­ting ed­u­cated and reg­u­lated. He con­tin­ues, “Phar­ma­ceu­ti­cal com­pa­nies tend to ei­ther over en­gi­neer or un­der en­gi­neer pack­ag­ing. There are two types; ac­tive and pas­sive. Ac­tive ranges from a sep­a­rate, in­di­vid­ual pack­age and full con­tainer to en­tire trail­ers and air­craft. Since ac­tive pack­ag­ing re­lies on its own ther­mo­static-con­trolled en­ergy source, the out­side tem­per­a­ture gen­er­ally doesn’t af­fect prod­ucts. But ex­ter­nal con­di­tions can af­fect pas­sive pack­ag­ing, which uses con­ven­tional pack­ag­ing com­bined with wet ice, gel packs, dry ice, or liq­uid ni­tro­gen (LN2), depend­ing on the tem­per­a­ture con­trol needed.”

Shankar Iyer, Di­rec­tor (Cargo) In­dia, Mid­dle East & Africa, Swiss WorldCargo, shares, “To main­tain qual­ity and prod­uct in­tegrity of tem­per­a­ture-sen­si­tive phar­ma­ceu­ti­cal prod­ucts, seam­less co­or­di­na­tion and col­lab­o­ra­tion among all par­ties in­volved is cru­cial. At Swiss WorldCargo, a first ini­tia­tive from our side was done through con­tin­ued in­vest­ment in our ‘

At­ten­tion to prod­ucts re­quir­ing spe­cific stor­age con­di­tions and the stock should be on the FEFO prin­ci­ple

qual­ity cor­ri­dors’ or net­work of cer­ti­fied trade lanes cov­er­ing global pharma routes. Out­side of these trade lanes and of our net­work, we place im­por­tance on all points along the sup­ply chain, es­pe­cially on the ground.” Ac­cord­ing to Ajay Khosla, Gen­eral Man­ager (NORO), Scor­pion Ex­press, “The cur­rent phar­ma­ceu­ti­cal sup­ply chain sce­nario in In­dia is ex­tremely com­plex. One of the main rea­sons for this com­plex­ity is the pres­ence of 60,000 plus re­tail phar­ma­cies which are spread across coun­try but ship­ment can be trans­ported to these dis­tant ar­eas through poorly con­nected routes and poor trans­port fa­cil­i­ties, this make cost of drugs much higher than the other de­vel­oped coun­tries. Presently, the cost of trans­porta­tion is more than 25-30 per cent of rev­enue gen­er­ated by phar­ma­ceu­ti­cal com­pa­nies but ef­fi­ciency of the cur­rent sys­tem has clearly not been demon­strated, still more than three-fifths of In­di­ans still do not have ac­cess to mod­ern medicines. This in­crease in pharma man­u­fac­tur­ing re­quires need of changeover present way of LSP work­ing and strengthen re­la­tion­ship among LSPs, fac­to­ries and mar­ket places.”

EN­SUR­ING EX­CEL­LENCE VIA CER­TI­FI­CA­TION

Ac­cord­ing to Ramesh Mami­dala, CEO, Celebi Delhi Cargo Ter­mi­nal Man­age­ment In­dia, “The prepa­ra­tion to achieve these cer­tifi­cates help and push the com­pa­nies (that seek the cer­ti­fi­ca­tion) to achieve some very strin­gent stan­dards for fa­cil­ity, pro­cesses, sys­tems, train­ing, staff and equip­ment.” “GDP and IATA CEIV Pharma guide­lines both are linked to qual­ity as the ob­jec­tive is to en­sure that in­tegrity of the prod­uct is main­tained through­out the sup­ply chain. Their han­dling guide­lines clearly de­fines re­spon­si­bil­ity and ac­count­abil­ity of each stake­holder in­volved in sup­ply chain while the goods are in their cus­tody and dur­ing chang­ing hands. These guide­lines help to meet cus­tomer ex­pec­ta­tion of com­pli­ance, stan­dard­i­s­a­tion, ac­count­abil­ity, transparency across the sup­ply chain with prop­erly trained

Phar­ma­ceu­ti­cals with tem­per­a­ture­sen­si­tive and shelf-life con­cerns ex­pe­di­ent ship­ping at­ten­tion

To main­tain qual­ity and prod­uct in­tegrity, seam­less co­or­di­na­tion and col­lab­o­ra­tion among all par­ties is cru­cial De­pen­dency on air lo­gis­tics need ad­di­tional air­ports, new reg­u­lar routes and ad­di­tional fa­cil­i­ties

stake­hold­ers on reg­u­la­tions and stan­dards with ad­e­quately equipped fa­cil­i­ties. More­over, IATA’s – Tem­per­a­ture con­trol reg­u­la­tions (TCR) chap­ter deals with pack­ag­ing, la­belling and han­dling of tem­per­a­ture con­trol phar­ma­ceu­ti­cal and health care goods. It would be a win-win sit­u­a­tion for the cus­tomers and in­dus­try if these guide­lines are prac­tised and fol­lowed,” trusts

Man­ish T Shah, Man­ag­ing Di­rec­tor, Mag­num Cargo. “IATA has recog­nised the air trans­porta­tion in­dus­try’s ef­fort to ad­dress phar­ma­ceu­ti­cal man­u­fac­tur­ers’ needs by de­vel­op­ing CEIV Pharma. This glob­ally recog­nised and stan­dard­ised cer­ti­fi­ca­tion for phar­ma­ceu­ti­cal air ship­ments en­sures that the right pro­cesses, peo­ple and in­fra­struc­ture are in place to han­dle and trans­port sen­si­tive ship­ments in com­pli­ance with ex­ist­ing in­ter­na­tional and na­tional reg­u­la­tory re­quire­ments,” tells Sachdeva. “Cer­ti­fi­ca­tions such as the IATA CEIV Pharma and GDP are im­por­tant through­out the in­dus­try as they pro­vide a ‘stamp of ap­proval’, of sorts, im­ply­ing that a car­rier is able to suf­fi­ciently carry out the safe han­dling and ship­ping of phar­ma­ceu­ti­cal prod­ucts,” feels Iyer. “CEIV clearly ad­dresses the need of the hour of pharma in­dus­try in terms pro­vid­ing glob­ally recog­nised and con­sis­tent prod­uct han­dling cer­ti­fi­ca­tions to en­sure more safety, se­cu­rity, com­pli­ance and ef­fi­ciency of goods. GDP is a qual­ity sys­tem for ware­house and dis­tri­bu­tion cen­ters ded­i­cated for medicines. The scheme en­sures that con­sis­tent qual­ity man­age­ment sys­tems are in place through­out your en­tire sup­ply chain, from the early de­liv­ery of raw ma­te­ri­als to the man­u­fac­tur­ing plants, to the fi­nal ship­ment of fin­ished drugs to the end user,” notes Vohra. “Ship­ping tem­per­a­ture and time-sen­si­tive phar­ma­ceu­ti­cals has al­ways been a tricky is­sue. As vol­ume in sin­gle trans­ac­tions are not very big to use much of cold chain sur­face trans­porta­tion so at still phar­ma­ceu­ti­cal in­dus­try re­lies and will con­tinue to rely on for some more time on air cargo for its speed and trust­wor­thi­ness and com­pe­tence in time sen­si­tiv­ity and tem­per­a­ture-con­trolled ship­ments. This in­creas­ing de­pen­dency on air lo­gis­tics re­quires ad­di­tional air­ports, new reg­u­lar routes and ad­di­tional fa­cil­i­ties at air­port ware­houses, con­ducive for car­ried prod­ucts,” says Khosla. “Cer­ti­fi­ca­tions such as GDP or the IATA CEIV scheme are hugely ben­e­fi­cial, as find­ing a di­rect route is the ideal thing to move tem­per­a­ture­sen­si­tive cargo, but most of time this is not pos­si­ble, so LSPs do their best to en­sure they have the right pro­ce­dures in place at tran­sit points and vis­i­bil­ity at des­ti­na­tion, not just at the point of ori­gin. Also, the use of tech­nol­ogy also helps re­duce the need to ded­i­cate man­power to fol­low ship­ments. Real-time re­port­ing of data such as lo­ca­tion tem­per­a­ture, hu­mid­ity or drops can help prob­lems to be iden­ti­fied quickly and re­act the sit­u­a­tion im­me­di­ately,” he adds. Adds Shah, “How­ever, in spite of these cer­ti­fi­ca­tions dwell time of prod­uct ex­posed to out­side tem­per­a­ture at the air­port tar­mac at ori­gin, hub and des­ti­na­tion, will still re­main a chal­lenge which is the ma­jor area of con­cern for

tem­per­a­ture con­trol prod­ucts. Also, CEIV cer­ti­fi­ca­tion has to still make its pres­ence in In­dia and it is very im­por­tant that all the stake­hold­ers in han­dling should be a part of this cer­ti­fi­ca­tion, ab­sence of any one in the sup­ply chain may de­feat the pur­pose.”

EVOLV­ING TECH­NOLO­GIES

“In air­freight busi­ness, there are sev­eral tech­nol­ogy-driven so­lu­tions avail­able that range from tem­per­a­ture probes to smart GPS RFID tags and to pack­ag­ing ma­te­rial that even changes the colour when not man­aged ap­pro­pri­ately. Probes have been very pop­u­lar as the cost is much lower as com­pared to other tech­nol­ogy so­lu­tions. How­ever, smart tags are be­com­ing pop­u­lar and get­ting cheaper. While probes only fa­cil­i­tate post-de­liv­ery anal­y­sis, the tags of­fer real-time mea­sure­ment and com­mu­ni­ca­tion which is a lot bet­ter if any process cor­rec­tions need to be made. For sur­face trans­port, the Blue­tooth-based tags work in tan­dem with a smart phone be­ing used by the driver who will be alerted to cor­rect when a de­vi­a­tion is about to hap­pen,” elu­ci­dates Mami­dala. “Op­ti­cooler is the lat­est de­vice which uses com­pres­sors in­stead of dry ice for cool­ing. In com­bi­na­tion with elec­tri­cal heat­ing, this can en­sure a con­stant in­side tem­per­a­ture of be­tween +2 and +30 de­grees Cel­sius. It has both the fea­tures of cool­ing as well as heat­ing which makes it unique. Also, data log­gers are adding value to the mon­i­tor­ing process in an­other pe­cu­liar way by record­ing the tem­per­a­tures vis-a-vis lo­ca­tion so that proper ac­tion can be taken at later point of time,” shares Vohra. Sachdeva points few tech­nolo­gies presently be­ing used to mon­i­tor tem­per­a­ture:

™ Elec­tronic tem­per­a­ture mon­i­tor­ing and event log­ger sys­tem for record­ing and re­port­ing air and/ or prod­uct tem­per­a­tures, with op­tional fa­cil­i­ties for record­ing and re­port­ing spe­cific events such as door-open­ing or de­frost cy­cles, and for is­su­ing alarms. Such sys­tems may be user-pro­gram­mable and may also be re­motely mon­i­tored via satel­lite link.

™ Map­ping doc­u­mented mea­sure­ment of the tem­per­a­ture and/ or rel­a­tive hu­mid­ity dis­tri­bu­tion within a stor­age area, in­clud­ing iden­ti­fi­ca­tion of hot and cold spots.

™ Air tem­per­a­ture mon­i­tor­ing sys­tems and de­vices should be in­stalled in all tem­per­a­ture- con­trolled rooms, cold rooms, freezer rooms, re­frig­er­a­tors and freez­ers used to store TTSPPs. Elec­tronic sen­sors should be ac­cu­rate to ± 0.5°C or bet­ter. Sen­sors should be in ar­eas where the great­est vari­abil­ity in tem­per­a­ture is ex­pected to oc­cur within the qual­i­fied stor­age vol­ume and they should be po­si­tioned so as to be min­i­mally af­fected by tran­sient events such as door open­ing.

™ Hu­mid­ity mon­i­tor­ing sys­tems and de­vices should be used in tem­per­a­ture-con­trolled rooms that are used to store TTSPPs that re­quire a hu­mid­ity-con­trolled en­vi­ron­ment. Mon­i­tor­ing sen­sors should be ac­cu­rate to ± 5 per cent RH and lo­cated to mon­i­tor worstcase hu­mid­ity lev­els within the qual­i­fied stor­age vol­ume.

™ Tem­per­a­ture and where nec­es­sary, hu­mid­ity alarm sys­tems should be linked to the mon­i­tor­ing sys­tem(s) with high and low alarm set points. There should be a vis­ual alarm and prefer­ably an au­di­ble alarm, to­gether with au­to­matic tele­phone dial-up or SMS text warn­ings to key per­son­nel. Men­tion­ing pack­ag­ing, track­ing and trace­abil­ity as an im­por­tant part of phar­ma­ceu­ti­cal end-to-end sup­ply chain for tem­per­a­ture con­trol goods, Shah says, “Tech­nol­ogy like RFID (Ra­dio fre­quency iden­ti­fi­ca­tion) in use is seen as a way to im­prove safety and se­cu­rity of the phar­ma­ceu­ti­cal sup­ply chain.” “Our di­verse range of so­lu­tions, in­clud­ing our SWISS Cel­sius Ac­tive, SWISS Cel­sius Pas­sive and SWISS Cel­sius Pas­sive So­lu­tions prod­ucts, are de­signed to help ef­fec­tively mon­i­tor tem­per­a­tures for global ship­ments. Our var­i­ous part­ners, in­clud­ing En­vi­ro­tainer, cSafe, Dokasch and vaQtec each play an im­por­tant role for us in pro­vid­ing over­sight and car­ry­ing out safe han­dling,” no­ti­fies Iyer.

The prepa­ra­tion to achieve these cer­tifi­cates help and push the com­pa­nies to achieve some very strin­gent stan­dards

GDP and IATA CEIV Pharma are linked to qual­ity as the ob­jec­tive is to en­sure that in­tegrity is main­tained

Vaib­hav Vohra In­dia Cargo Awards - Face of the Fu­ture 2017 & Man­ag­ing Di­rec­tor, Con­ti­nen­tal Car­ri­ers

Ra­hat Sachdeva In­dia Cargo Awards - Face of the Fu­ture 2017 & Vice Pres­i­dent, Ra­hat Con­ti­nen­tal

Gen­eral Man­ager (NORO) Scor­pion Ex­press Ajay Khosla

Shankar Iyer Di­rec­tor (Cargo) In­dia, Mid­dle East & Africa Swiss WorldCargo

Ramesh Mami­dala In­dia Cargo Awards - DDP Game Changer 2016 & CEO, Celebi Delhi Cargo Ter­mi­nal Man­age­ment In­dia

Man­ish T Shah Man­ag­ing Di­rec­tor Mag­num Cargo

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