Pharmaceutical validation impacts every quality critical aspect of the pharmaceutical drug manufacturing process, including all equipment, components and computer-controlled systems that are used within the industry. A major part of the pharmaceutical validation process is in the documentation that is used to record and provide regulatory evidence that 100% clarity and traceability has been achieved.
In today’s supply chain, the printer would be considered a critical component in the manufacturing process and a key element of pharmaceutical equipment validation when located within a pharmaceutical production line – and with regulatory complexity increasing – not to mention industry-wide moves towards just-in-time production processes, no organisation can afford to omit this critical component.
Yet, the unfortunate reality is that many organisations may not have the resources or in-house technical knowledge to create validation documentation that would help them to meet the industry regulatory requirements needed for ongoing compliance.
With the considerable risk and implications of non-compliance, this article, outlines how pharmaceutical companies can ensure their user requirements can be met when integrating Domino printers and lasers within their production processes.
What is pharmaceutical validation?
Pharmaceutical validation is the documented process of proving that equipment, systems, and manufacturing processes consistently perform as intended and comply with regulatory requirements.
Market context
Good Manufacturing Practice (GMP) Validation is an essential element of quality assurance and pharmaceutical manufacturing compliance underpinning the safety of pharmaceutical and biotech products and processes.
GMP was initially set out by the US FDA and the Code of Federal Regulations and has now been widely adopted by regulatory bodies globally such as Europe’s EudraLex and the UK’s MHRA. In Europe, validation activities are further defined through EU GMP Annex 15. Increasingly, other international regulators have followed suit, including Australia’s TGA and India’s Schedule M.
The risk of non-compliance is significant, albeit difficult to measure. From potential regulatory fines and loss of brand reputation, to the forced shutdown of a full production line and associated 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 must demonstrate in a documented form that the processes, methods, tests, activities, and equipment they deploy are capable of repeatedly producing the desired product. Each critical step in the manufacturing process must be validated to perform as intended under defined conditions, forming a core part of pharmaceutical process validation activities.
What documentation is typically required?
The documentation associated with pharmaceutical validation includes:
- Standard operating procedures (SOPs)
- User requirement specifications (URS)
- Risk assessments (failure mode and effects analysis [FMEA], data integrity assessment)
- Validation master plan (VMP)
- Qualification protocols and reports (design, installation, operation, performance, [DQ, IQ, OQ, PQ])
- Validation protocols and reports (process and computer systems [PV, CSV])
Critical components
Labelling and label printing are critical final components of the pharmaceutical validation process and play an important role in maintaining ongoing pharmaceutical manufacturing compliance.
It only takes one stray label, instruction for use, 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.
How can pharmaceutical manufacturers simplify printer validation and compliance?
The most reliable suppliers will be proactive in ensuring system validation and supporting pharmaceutical equipment validation; checking that what is required in the user requirement specification (URS) is delivered without errors; and providing a risk assessment, test strategy, good document standards, and training protocols.
A dedicated, validation-trained expert will know exactly what is needed to achieve pharmaceutical 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?
Domino provides the expertise and guidance needed for pharmaceutical manufacturing compliance and validation. Learn more about Domino’s solutions for the life sciences sector to see how we can support your compliance journey.