To make the complex pharmaceutical supply chain safer and more efficient, manufacturers are looking at streamlining labelling operations to minimise recalls and line interruptions while enhancing quality and safety.
The primary function of pharma labelling is to provide the correct information to both the medical practitioner and patient. It is used to ensure rigorous quality control procedures and correct inspection and numbering in accordance with the requirements of the country where it will be distributed coupled to their regulatory labelling standards for pharmaceuticals. 1
In today’s supply chain, the printer is arguably the final element in the validation process, and with regulatory complexity increasing, not to mention industry-wide movement towards last-minute production processes, organisations cannot afford to omit this final stage of compliance.
With multi-territory ingredient sourcing and manufacturing, new products are continually entering the market, but the complex ecosystem of regulations and standards for different territories means
it is challenging to keep track of a highly integrated supply chain – from validated raw material and ingredient sourcing to the final label on pack. Patient safety is the most important consideration for a pharma manufacturer: no one should drop the ball at the final labelling stage.
Track & trace & central database
When looking at critical vulnerabilities in a pharma supply chain, sole sourcing comes up trumps, with nearly 50% of pharma executives surveyed in a McKinsey Global Institute Survey citing this as a major concern, while another 25% pointed to a lack of visibility into supplier risk. Companies can minimise disruptive effects through greater visibility, rigorous risk management and newer technologies to better anticipate and respond to shocks, including supply chain disruption caused by faulty labelling. One of the ways in which to achieve this is to implement a central database. 2
Pharma logistics are often multi-tiered, as numerous borders are crossed. Adopting a centralised approach to labelling could assist when working within an existing enterprise resource planning and project lifecycle management system.
One of the biggest benefits of a central database is that it allows you to replicate data, which could lead to a reduction in errors and improved consistency for plant and distribution partners internationally. This could ultimately drive greater supply chain efficiency and the ability to trace pharmaceuticals to verify legitimate products, pick up any illegitimate products or to action a recall.
This is no longer a nice to have, but a critical component to build consumer confidence. When coupled with a comprehensive enterprise labelling solution, pharma companies can now rapidly respond to changing regional and international regulatory requirements with regards to labelling and data-driven label content – with the flexibility to address requirements quickly while minimising validation and approval times.3
Label compliance & GMP
Pharma companies that do not want to be caught on the back foot must constantly respond to customer and supplier label demands. These requirements are varied, including 2-D and linear barcodes, serialisation, updated regulatory symbols, logo placement or other branding demands, language variations, location specific information, country-specific regulation and labelling that enables healthcare providers to better monitor patients. 4
Comprehensive enterprise labelling enables pharmaceutical companies to respond rapidly to changing regional and international regulatory requirements – streamlining workflow. Should formulations change quickly, implementing an enterprise labelling solution will enable you to change product data in real time while standardising labels and templates, making it simpler for global compliance audits. A sole source of information will furthermore ensure uniformity and conformity.
It is especially important to validate pharmaceutical labelling compliance to ensure good manufacturing practice. In fact, it impacts on every process and component of pharmaceutical production, including machines, systems, equipment, and computer systems. A large part of the validation and compliance process lies in the documentation – requiring integrated support for documentation with complete clarity and traceability.5
Good manufacturing practice (GMP) validation is an essential element of quality assurance underpinning the safety of pharmaceutical and biotech products and processes as set out initially by the FDA and now widely adopted by regulatory bodies globally, such as the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA). Increasingly, other international regulators have followed suit, including Australia’s Therapeutic Goods Administration (TGA) and India’s Schedule M, with new regulatory requirements around pharmaceutical serialisation due to come into force in Russia, Brazil, Indonesia, and China within the next two years – this could further impact the pharmaceutical supply chain. 7
The risk of non-compliance is significant. From the potential regulatory fines and loss of brand reputation to the temporary forced shutdown of a full production line and cost of remediating the situation, not having validated systems and processes in place could have a potentially catastrophic impact on any business.
Every pharmaceutical manufacturer will be aware of the requirement for GMP validated products and processes, whereby the company must demonstrate in a documented form that the processes, methods, tests, activities, and equipment they utilise are capable of repeatedly producing the desired product.
Labelling and label printing are critical final components of the validation process, and it only takes one stray instruction for use to cause a product recall – an action no company wants to risk.8
As a trusted partner in pharma distribution, Clarity Pharma’s team of experts are on hand to assist you through every step of your pharmaceutical product’s journey. Do not hesitate to contact our sales team on +44 (0) 3332 413520 for more information.