The Importance of Pharmaceutical Labelling Compliance

1. The Importance of Pharmaceutical Labelling Compliance

2. Impacting every single process and every minute component of the production of pharmaceutical products, validation and compliance extends to machines, systems, equipment and computer systems. Documentation forms a significant element of the compliance process, and pharmaceutical companies typically require integrated support for this, with clarity and 100% traceability. In modern pharmaceutical supply chains, the printer is at the end of the validation and compliance process, but is no less important than any other element. With the complexity and speed with which regulatory compliance is growing, and an industry shifting towards last-minute production processes, no company can afford to omit this final stage, or cut corners in any way.

3. That said, many companies producing pharmaceutical goods, have no clue that their printer validation packs are not complete and are not in compliance with US Food and Administration (FDA) regulatory requirements. There are significant risks and implications involved with any form of non-compliance when it comes to pharmaceutical labelling, so it’s vital that organizations ensure their User Requirement Specification (URS) adequately cover the final stage of the production process: labelling.

4. Let’s put this in a market context: GMP, or Good Manufacturing Practice validation underpins the safety of pharmaceutical products and processes as outlined by the FDA, and adopted by regulatory bodies like the European Medicines Agency (EMA), and UK Medicines and Healthcare products Regulatory Agency (MHRA). When an organization is non-compliant, they risk incurring a hefty regulatory fine, and damaging their brand’s very own reputation, too. In some cases, a company may be forced to temporarily cease all production, and then spend thousands of dollars remediating the situation. Non-validated systems and processes have the potential to cause significant damage to a company in more ways than one, hence it pays to have GMP validation from the outset.

5. What documentation is associated with pharmaceutical validation? It’s essential that each and every step in the entire manufacturing procedure is validated to perform as required under certain, defined conditions, and the documentation associated with this includes the following: • SOP’s or Standard Operating Procedures • Specifications • VMP or Validation Master Plan • Qualification protocols and reports • Validation protocols and reports

6. The importance of labelling and label printing in the validation process: Vital components of the pharmaceutical validation process, labelling and printing issues have been the cause of many medical device recall events, and responsible for the return of over a million units. It takes just one stray label, instructions for use or printing error to cause a product to be recalled, at huge expense to the pharmaceutical company. If a faulty print ribbon has caused the contents of a label to become unreadable or open to misinterpretation, and the product reaches the supply chain before the error is detected, not only will regulations have been breached, but the safety of patients is at risk.

7. How can suppliers ensure system validation? Proactiveness is key when it comes to guaranteeing system validation, and everything must be checked, checked, and checked again. Risk assessments must be provided and a test strategy devised, along with following good document standards and implementing a high level of training protocols. An expert trained in Good Automated Manufacturing Practice (GAMP) will be able to help suppliers to achieve exactly what is needed for appropriate validation in a pharmaceutical production environment, including validating any extra systems integration, such as labelling or Enterprise Resource Planning (ERP).

8. It pays not to leave anything to chance when it comes to compliance of pharmaceutical validation processes, and working with a third party such as a reputed life sciences organization, can help ensure that your processes and end products, hold up under scrutiny. Agile scientific Group in Columbus OH is a life sciences organization that brings decades of industry knowledge, expertise, processes, best practices, and systems to companies. Agile Scientific’s clinical services function to accelerate all facets of drug development, ensure compliance at a global level and optimize pipeline value / ROI. Agile Scientific Group LLC is fortunate to partner with smaller virtual organizations and Fortune 500 Life Sciences companies alike. We have extensive experience providing focused, pragmatic clinical solutions to our sponsor Life Science organizations and CRO’s across all areas of Drug Safety, Regulatory Affairs, HEOR / Pharmacoepidemiology, Quality Assurance.