Validation impacts every process and component of pharmaceutical production, including machines, systems, equipment and computer systems. Part of the validation process is in the documentation—there needs to be integrated support for documentation with 100% clarity and traceability. In today’s supply chain, the printer is arguably the final key element in the validation process – and with regulatory complexity increasing – not to mention industry-wide moves towards just-in-time production processes, no organisation can afford to omit this final stage of compliance. Yet, the unfortunate reality is that many organisations may not realise that their printer validation packs are incomplete and therefore not meeting the FDA regulatory requirements. With the considerable risk and implications of non-compliance, Bart Vansteenkiste, life science sector manager, Domino Printing Sciences, outlines how pharmaceutical companies can ensure their User Requirement Specification (URS) covers the final element of the production process.
Market context
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 US FDA and now widely adopted by regulatory bodies globally such as Europe’s EMA and the UK’s MHRA. Increasingly, other international regulators have followed suit, including Australia’s TGA and India’s Schedule M, with new regulatory requirements around pharmaceutical serialisation due to come into force in Russia (1st January 2020), Brazil and Indonesia (2021) and China (2022) that will further impact the pharmaceutical supply chain.