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 Sciences Sector Manager, Domino Printing Sciences, outlines how pharmaceutical companies can ensure their 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. New regulatory requirements around pharmaceutical serialisation came into force in Russia (1st July 2020) and are due soon in Brazil and Indonesia (2021) and China (2022) that will further impact the pharmaceutical supply chain.
The risk of non-compliance is significant, albeit difficult to measure. From the potential regulatory fines and loss of brand reputation, to the temporarily forced shutdown of a full production line and the cost of remediating the situation, not having validated systems and processes in place could adversely impact any business.
Every pharmaceutical manufacturer will be aware of the requirement for GMP validated products and processes, whereby the company has to demonstrate in a documented form that the processes, methods, tests, activities, and equipment they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be validated to perform as intended under defined conditions.
The documentation associated with validation includes:
- Standard operating procedures (SOPs)
- Specifications
- Validation master plan (VMP)
- Qualification protocols and reports
- Validation protocols and reports
Critical components
Labelling and label printing are critical final components of the validation process. In 2018, 9% of all medical device recall events – and the return of over a million units – were due to labelling issues, with printing errors undoubtedly a factor. It only takes one stray label, IFU or printing error to cause a product recall. A trivial issue like a faulty print ribbon, for example can lead to missing, unreadable, or misinterpreted content. When this goes undetected and products reach the supply chain, regulations are breached, and patient safety is put at risk. Moreover, with an increasing move towards just-in-time production processes, organisations need to ensure they’ve got robust mechanisms in place to assure batch integrity. Concerningly, most organisations are unlikely to realise that their printing systems don’t comply, until the regulators come knocking.
The most reliable suppliers will be proactive in ensuring system validation, checking that what is required in the User Requirement Specification (URS) is delivered without errors; providing a risk assessment; test strategy; good document standards; and training protocols. A dedicated, GAMP V trained expert will know exactly what is needed to achieve validation in a pharmaceutical production environment, including validating any additional systems’ integration – such as a labelling or ERP system – and will provide the validation pack to support that.
It’s ever more important that a company’s printing systems’ rationale can stand up to the scrutiny of an audit. So why leave the compliance of the final component of the validation process to chance?