Packaging
In Highly-regulated Industries your Labelling Must Speak for your Product – Compliance is Non-negotiable! Computerised systems validation is essential for medical device and pharmaceutical manufacturers. Here, Beth Peckover, VP Global Delivery at Kallik, pinpoints the three areas businesses need to get right to ensure computerised systems used for labelling meet all GxP requirements set out by industry regulators. Validation of computerised systems is a non-negotiable requirement enforced by regulators such as the FDA in the US, EMA in Europe, TGA in Australia, and HSSC in Canada. The ability to demonstrate adherence to appropriate practice and processes that underpin a quality-driven, risk-based approach to computerised systems validation is a pre-requisite to being able to operate in any highlyregulated market, including medical device and pharmaceutical manufacturing. As part of GxP regulations, manufacturers involved in these highlyregulated industries must adhere to Good Manufacturing Practices (GMP) defined as “a system of processes, procedures, and documentation that help ensure that products are consistently produced and controlled according to quality standards”. It’s necessary to zero in on GAMP 5 guidance for GxP computerised system compliance and validation – this is the standard regulators work to.
are not willing to bear the validation burden of implementing a new system. Validation of newly-built computerised systems is an involved task. It can take several months to complete successfully. Usually, it entails performance, operational and infrastructure qualification of regulated systems used to manufacture medical devices and pharmaceuticals. Product Recalls Carry a Heavy Cost Correct labelling is a key requirement for manufacturers of medical devices and pharmaceuticals. Analysis of FDA drug recalls shows that, between 2017 and 2019,
14.9% of recalls occurred due to labelling issues. Recent statistics also highlight that 9% of global medical device recalls were due to label errors, equating to over one million items. The FDA explains that medical device manufacturers must incorporate several elements in their quality assurance (QA) programme that relate to labelling in order to meet the GMP requirements of quality system regulation. The potential damage to consumers and company reputation due to a recall from not meeting these standards is extreme – patient safety can be put at
Outdated Labelling Systems are in Need of Overhaul Enterprise labelling is a classic area where computerised systems play a vital role in providing the highest quality and most accurate description and branding of products, such as medical devices and pharmaceuticals. Meeting these regulations requires applying the best quality management systems and standard operating procedures (SOPs) to the design, development and delivery of labelling software. Medical device and pharmaceutical labelling is ripe for modernisation, but many manufacturers are still using outdated systems for product labelling because they 80 INTERNATIONAL PHARMACEUTICAL INDUSTRY
Winter 2020 Volume 12 Issue 4
