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www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 25 wholesale distributors and their compli- ance with the guidelines. For now, there is no single global GDP standard despite the harmo- nization efforts of bodies such as the International Council for Harmonisation (ICH), European Compliance Academy ( E CA) a nd t he P h a r m a c e ut ic a l Inspection & Co-operation Scheme (PIC/S). There are literally dozens of national and regional GDP standards in operation around the world. And although most of these are similar and operate under Marketing Authorization Holder (MAH) and Wholesale Dealer Authorization (WDA) type licensing systems, there can be much difference when it comes to detail and enforcement. SYSTEMIC FLAWS GDP guidelines are basically an exten- sion to the GMP regulations which are in force around the world to govern the quality of manufacture of pharma- ceuticals and their ingredients. These guidelines cover clinical trials as well as commercial drugs, APIs, and veterinary products. However, despite this common starting point, GMP is fundamentally different from GDP in that the GMP process takes place within a relatively controlled environment whereas GDP processes largely take place at arm's length, outside the direct control of the manufacturer and involving numerous organizations of varying competence, expertise, and scale. These supply chain dependencies are both critical and unavoidable, creating a high number of dilemmas and vexations that are endemic to the pharma-logistics process. These include: • Supply chain fragmentation— logistics is one of the world's most fragmented business sectors ren- dering it notoriously difficult to control and change. • Fragility and low resilience—the vulnerability of the global logis- tics chain to large-scale disruption has been cruelly exposed by the COVID-19 pandemic. • Variable infrastructure—huge handling and storage variabilities in terms of both capability and capacity, especially cold-chain, are apparent across countries and markets. • Duplication of effort—collec- tively the industr y unneces- sarily replicates an enormous swathe of work especially in relation to asset utilization and quality compliance. • Security vulnerabilities—these especially relate to counterfeit product, which is driving track- and-trace legislation. • Poor consignment visibility— another product of structural fragmentation which precludes dynamic product monitoring and timely interventions. • Supply chain opacity—the indus- try's congenital 'silo mentality' and protectionism curtails co-op- eration and inhibits the develop- ment of supply chain trust. • Training shortages—rising stan- dards and regulatory demands have highlighted a dearth of good GDP training in many locations. • Sustainability issues—the car- bon footprint of shipping med- icines (especia l ly by air) is a growing concern. • Technical standards—the absence of universal technical standards is an impediment to sustained improvement across the sector. • R ising costs—t he e x plosion in freight rates, both air and sea, over the past 12 months is forcing pharmaceutical companies to look closely at long-haul distri- bution costs. Taken together, these factors create a degree of complexity that makes the consistent and reliable execution of GDP across the pharma supply chain a very elusive goal. Indeed, a survey (5) had no less than 40% of pharmaceutical ship- pers and logisticians citing the reduction of complexity as one of the biggest per- ceived benefits of greater GDP collabo- ration and harmonization (see Figure 1). All this points to the existence of a huge amount of unnecessary replication, regulatory revisionism, compliance ambi- guity, and reinventing of wheels when it comes to good distribution practice. QUESTIONING THE LOGIC OF LOGISTICS Any system for improving and stream- lining GDP compliance is contingent on a comprehensive review of contem- porary quality policies and procedures, for example, by questioning the ratio- nale behind each individual pharma- ceutical company: • finding, assessing, and validating large numbers of different carri- ers and suppliers • developing and maintaining dis- crete operational qualif ication (OQ ) and performance qualifi- cation (PQ ) test protocols • designing multiple system and product evaluation and qualifica- tion programs • conducting rigorous training pro- grams for ever-changing products and pack-out permutations • continuously replicating arguably interchangeable lane validations? • generating la rge numbers of proprietary standard operating procedures (SOPs) and key per- formance indicators (KPIs) • using/developing digital quality monitoring systems that are not interoperable. GDP EXCEPTIONALISM Whether or not it is possible to prag- matically address all the various issues at play in the world of pharma, GDP is down to questioning embedded beliefs and practices as well as having a good understanding of the context in which they have developed. For instance, the notion that each and every medical product and shipping lane requires a dedicated transportation protocol needs to be challenged in the light of the lat- Quality and Regulatory Sourcebook Regulations: Supply Chain