Regulatory bodies have increased awareness about falsified drugs and subsequently worked out requirements to prevent falsified drugs entering the legal pharmaceutical supply chain.
The basic idea is about “knowing its supply chain”. It appears simple in principle, but it is not in reality.
How come that in one of the most regulated industries in the world, 100% of the stakeholders ignore their full supply chains? Numerous aspects explain this matter of fact.
In general, downstream value chain is known and traceable since Pharmacovigilance has to be ensured. On the other hand, upstream value chain is far less mastered. Stakeholders know well their tier one suppliers and suppliers beyond become (almost) distant satellites.
There is one exception imposed by regulatory bodies regarding active pharmaceutical ingredients. That is the only supplied category for which a market authorization holder is requested to have in depth-knowledge. This means, focus and efforts are primarily targeted to this supplier category.
Companies put in place various processes and tools to ensure accurate Supplier Management Systems. These systems currently suffer from scattered information throughout IT systems, servers, MS Excel files, emails, papers, etc. Which in return means a clear lack of traceability, hence a clear lack of access to information, hence a clear lack of transparency and integrity of data.
On what exactly are the decisions taken by the Qualified Persons?
Not only companies lose immense time (hidden costs at all levels of the upstream supply chain) on putting bits and pieces together when needed, but how is this acceptable in case of an inspection or worse, a drug recall?
Increased volumes of data combined with ongoing shifts in supply chains and existing manufacturing complexities bring out five important reasons why supplier compliance information flows should be digitized.
Pre-requisite to digitization is very often data cleaning and structuring. That is because data is spread among various sites, departments, formats, systems.
Digitizing supplier compliance information enables a) to work with homogeneous information throughout the company more efficiently, b)to provide access to all employees to the information and c) to automate certain processes.
Because the information flows are harmonised and available to all relevant stakeholders within the company, it dismantle existing siloes between the sites and/or between the departments.
Whether the pharmaceutical company - or any supplier - is audited by authorities or clients, it is requested to demonstrate that the supply chain works according to GMPs. Practice shows this is a painful exercise as it takes numerous people to collect a big amount of documents.
It becomes clear that digitizing supplier compliance information will simplify the demonstration as it enables full traceability of information flows between suppliers and their clients. It also enables to easily share down and up-stream information with relevant stakeholders, necessarily speeding up the whole process.
Because information is no longer scattered, information is harmonised avoiding multiple entries, and traceable, it drastically improves supplier assessments and helps to identify possible bottlenecks or risk factors on suppliers and/or on finished dosage forms.
Digitized supplier compliance information helps to keep a dynamic, hence proactive approach on changes, which immediately enhances change control for the market authorization holder.
Since digitized supplier compliance information enables access to all relevant stakeholders withing the company, it eliminates siloes. By doing so, it enables to build a big picture of the happenings related to Supplier compliance matters, then again improving risk management.
It seems evident that digitizing the supply chain compliance data is a win-win-win undertaking for the industry, the regulatory bodies and the patients.
Yet, we see there is a major constraint: in order to achieve those significant benefits, such a digitizing system should be able to communicate with numerous existing IT-systems.
Rephine Sourcing Ltd has been investigating this topic among the industry for years now and collected valuable expertise on how to efficiently alleviate processes related to supplier compliance. Feel free to check it out: www.rephinecatena.com