< PreviousPACKAGING20Pharma Business International www.pbiforum.netPharmaceutical packaging has comeunder pressure lately to do more to preventcounterfeit drugs being pushed as branded.With so many requirements already in place,the industry is being squeezed from everyangle. The industry relies on innovation,which is itself driven by the need forproducts to give across more informationthan ever before, remain totally securethroughout and also shrink the carbonfootprint as much as possible. In manymarkets, government regulations are alreadystipulating the traceability of pharmaceuticalpackaging, or will do so in the near future.This has led to major overhauls of thepackaging process in many companies -and some find this a challenge.Manufacturers can spend a lot of money tobe theoretically compliant and then throughsimple operational or product changeovererrors do something like putting the wrongCheckthe fine printThe pharmaceutical packaging industryremains at the forefront of innovation,despite how some may claim the look ofdrug packaging hasn’t changed.20-23_Layout 1 08/02/2017 16:18 Page 1PACKAGINGPharma Business International 21www.pbiforum.netlabel on the package. When there aremultiple changeovers, short batch runsand often a large product portfolio tomanage, there are certainly manypotential flashpoints.Consumer demand and changes inhow people use pharmaceuticalproducts, leading to a rise in smaller sizepacks, has also driven innovation in thepackaging sector and this means therehas been a rapid growth in thin walledpackaging, mostly for injection mouldingand thermoforming applications.Packaging also has a larger role to playin anti-counterfeit measures than manyother aspects of the supply chain. Withbootleg or counterfeit pharmaceuticalproducts being a multi-billion poundblack market, there is a need to crackdown on it where possible. Counterfeit-proof packaging is one such approach,with seals and locks to show a consumerwhen something has already beenopened. But there are other aspects tokeep in mind, namely that as the industrybecomes more proficient - so too dothose operating on the illegal side ofthings. Authorisation signs such ashologram stamps can be harder tomimic, but it’s important that theconsumers know to look for these -otherwise there isn’t going to be anybenefit. One way to draw attention to it isthrough marketing - perhaps with somekind of ‘always look for the stamp’campaign to draw attention to the threat.Visible holograms with company logos,combinations of letters and digits,22 Á20-23_Layout 1 08/02/2017 16:18 Page 2PACKAGING22Pharma Business International www.pbiforum.netinstantly identify the blister packs as originals.Invisible codes that can be verified quickly andeasily can also be incorporated into thehologram. All that is required for verification ofa hidden logo or data matrix code is a simplelaser pointer.The need for effective labelling andserialisation are also major concerns forinnovation in pharmaceuticals packaging. Forexample, this year will see the implementationof new guidelines in Saudi Arabia, where drugpackaging must be equipped with a data matrixcode step by step, with serial numbers havingbecome required in 2016. In Brazil, individualbatches must now be serialised, while the USFood and Drug Administration aspires toimplement a standardised identification for allprescription drugs in form of a 2D data matrixcode in a step-by-step approach until the endof 2023. The European Union’s FalsifiedMedicines Directive, meanwhile, stipulatescoded packaging with a 2D data matrix codeand a unique serial number for nearly allprescription drugs, which is expected to berequired by 2018. The aim is all cases is toensure consumers and dispensers can becertain that the products are official.For several years its been possible tocompletely automate the remote setting up ofdate code and barcode scanners, ensuring thelabel is correct, and correctly applied, right firsttime, every time. To virtually eliminate theoperator risk, such systems, as one mightexpect, are not cheap, but compared with therisk of batch rejection, rework, scrap, fines fornon-compliance and upset customers, thisautomation should be seen as a manufacturingnecessity.It’s not enough to have a single line, however,and a certain degree of flexibility will berequired in order to cater to the varied andstringent labelling requirements of differentmarkets. Perhaps, with all that in mind, it’s easyto see why many have turned to outsourcedcontract packagers within the industry.20-23_Layout 1 08/02/2017 16:18 Page 3Pharma Business International 23www.pbiforum.netPACKAGINGThe US Food and Drug Administrationaspires to implement a standardisedidentification for all prescription drugs inform of a 2D data matrix code in a step-by-step approach until the end of 202320-23_Layout 1 08/02/2017 16:18 Page 4COMPLIANCE24Pharma Business International www.pbiforum.netApprovedfor successApprovedfor success24-27_Layout 1 08/02/2017 16:19 Page 1Pharma Business International 25www.pbiforum.netCOMPLIANCEEnsuring new products meet with the approval of governing bodies can be along and frustrating process, but ensures greater success in the long runThe pharmaceutical sector is one of the mosttightly regulated of all – unsurprising whenproduct safety has to be absolutely intense toensure products reach consumers at the highestquality and avoid potential flashpoints. Happily,manufacturers and distributors are meeting theserequirements; ensuring products are produced ina clean and secure environment.Pharmaceutical companies are expected tocomply with the various criteria introduced byorganisations such as the FDA and the EU. Oneway in which they can do this is by making useof high quality inspection and detection systems.Chief among the requirements from many bodiesis that the clinical trials stages of a drug’sdevelopment are adhered to as stringently aspossible.Clinical trials often make or break a newproduct, with much of the future success ofhuge investments being determined on how theproduct interacts with humans. While there isalways vast amounts of tests that should – andwill – have been undertaken on the product,there is always the disastrous possibility thatthere will be an adverse reaction when it isintroduced to volunteers in the clinical trials.26 Á24-27_Layout 1 08/02/2017 16:19 Page 2COMPLIANCE26Pharma Business International www.pbiforum.netClinical trials only come into play oncethe preclinical and testing procedureshave been completed, and in most casescan only be undertaken after receivingapproval by an authorised body such asthe FDA. Figures suggest that it can takeup to ten years on average, and cost anincredible $2.6 billion for a drug to makeit through all the stages of clinical trials.And less than 12% of new medicineseven make it past FDA screening, andinto phase 1 of clinical trials. And it is amulti-phase process, of course. In mostcases it will first be tested on a smallnumber of volunteers, with the results ofsuch being monitored before it is thentested on hundreds – and eventuallythousands of volunteers.Compliance with these requirements isa difficult hurdle, but one all companiesare faced with and must adhere to. It’snot just trials where compliance need beobserved, however, and there isincreasing focus on high standards withinthe laboratory now as well. For manycompanies this takes the form of the GLPor Good Laboratory Practice.In most cases GLP refers to a qualitysystem of controls and management forlaboratories, which helps to make surethat there is a certain reliability andintegrity to any results. This involves anumber of requirements, as any goodnon-clinical research must be consistent,reliable and above all reproducible. GLP was born in 1972 in New Zealandand Denmark, but only spread to the USin 1978 following a BioTest Labs scandal.The Organisation for Economic Co-operation and Development (OECD)helped to spread the principles of GLP tomany other countries, and now it iscommon around the world. Obviously GLP does not refer to thebasic safety necessities of lab health andsafety, such as gloves, glasses and PPE.These are basic requirements that shouldcome as standard in every way. GLP is split into many differentcategories, all of which carry equalimportance in the eyes of the OECD. Theresponsibilities of individual personneland their roles are clearly defined, as isthe need for these members of a team ifany are not present. The guidelines are mostly broken downinto the different stages of research,including test facility organisation andpersonnel – which looks into theresponsibilities of the Study Director,Principal Investigator and StudyPersonnel. These aim to ensure thatstudies are carried out in a way thataligns with conduct requirementsexpected of the positions. There are alsoguidelines to indicate and set upexpectations for the recording,documenting and archiving process. Following after that is QualityAssurance programmes, including theresponsibilities of QA Personnel withinthe lab. Facilities in general, whichinvolves not just test system facilities butalso facilities for handling tests andarchiving. Waste disposal is also covered,particularly with the hazardous anddangerous nature of many by-productscreated in the lab. When it comes to study plans andreports, the GLP lays out requiredcontent for the study plan in terms ofaims and goals, details of the sponsorand any additional test facilities involvedin the tests, and much more. The goalhere is to ensure that any and alltransparency is observed when it comesto looking over or publishing the resultsof any tests. Scandals in past years haveshown that labs sponsored by individualcompanies may find results that benefitthose companies to the detriment ofscientific protocol. GLP can help reducethis, or at least put safeguards into placethat allow investigators to look back overthe process and identify if this might bethe case.GLP has always been referenced assomething of a guideline, but for manycountries certain aspects – or the entirety– of it have been put into law. TheEuropean Union adopted two basicDirectives and a Decision relating to theapplication of the GLP principles in 1987,while some changes were made to this in2004, much of it still does apply. Theseinclude compulsory audits andinspections to ensure that lab facilitiesconform to GLP rules and regulations –so it is very much an issue ofcompliance.24-27_Layout 1 08/02/2017 16:19 Page 3Pharma Business International 27www.pbiforum.netCOMPLIANCE24-27_Layout 1 08/02/2017 16:19 Page 4TRANSPORT & LOGISTICS28Pharma Business International www.pbiforum.netTransport remains one of the mostcostly and complicated parts of thesupply chain for many in thepharmaceutical manufacturing industry,and is often scene as the go-to locationfor cutting costs, improving efficiency –or limiting environmental waste. Over the years however the industryhas been squeezed so much, not only bycompanies looking to cut costs – but alsoever-increasing costs of fuel and taxrelated to it. While more recent cuts inthe cost of oil have had a beneficial effecton the industry, suppliers were quicklyexpected to pass those savings on totheir customers. One of the big questions faced bymany manufacturers in this situation –one of needing to transport fragile andstrictly-regulated goods more often tomeet quotas, is whether they should seekto increase their transport fleet – and allthe costs associated with it, or whetherthey should look to invest in morefacilities closer to the destination, usuallyin the form of warehouse or storagespace.While the latter certainly sounds likethe most efficient long-term option, it isby far the more costly one – which is adirect result of the supply and demandfor high quality warehouse space at thistime. Simply put, there is not enoughGrade A warehouse space to go around,and when companies are dealing withlarge quantities of pharmaceutical goodsthat need to be kept at a regulatedtemperature – there really is a necessityfor the warehouse space to be of thehighest quality. As the available space decreases,chances are the cost of rental willincrease. And this only gets worse whenwe consider that consumer demand forgoods is not likely to slow in comingyears. In fact, with it being predicted thatby 2050 the population of the world willtop nine billion, with over 65% of thatFrom pointto point Transport is a go-to location for cutting costs, but howmuch further can the industry be stretched?30 Á28-31_Layout 1 08/02/2017 16:19 Page 1Pharma Business International 29www.pbiforum.netTRANSPORT & LOGISTICS28-31_Layout 1 08/02/2017 16:19 Page 2Next >