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In the life sciences, maintaining high quality standards is critical not only to the success and sustainability of organizations but also to patient safety and compliance. ISO 9001:2015, part of the ISO 9000 family, provides a robust framework for quality management systems (QMS) that can be used in organizations in the life sciences, including pharmaceutical, […]

Introduction A few weeks ago, Sofie and Abbie introduced the pillars of the ISO 13485:2016 standard and explained why organizations benefit from certifying their Quality Management System (QMS). Convinced of the advantages of investing in ISO 13485:2016 certification, we now share how to prepare effectively for the certification audit. ISO 13485:2016 Readiness Plan A thorough

What is equipment qualification? Equipment qualification is a series of inspections, tests, and assessments to ensure that a given piece of equipment is compliant and ensures reliable performance. It is required to prove that a given piece of equipment does, on a consistent basis, what it is supposed to do. In the pharmaceutical industry, equipment

Introduction In the rapidly evolving landscape of medical devices, ensuring the highest quality standards is not only a legal requirement but also crucial for patient safety. Both manufacturers, importers and distributors can rely on the ISO 13485 standard, a globally recognized standard for quality management systems within the medical device sector. Compliance with ISO 13485:2016

In the multifaceted domain of pharmaceutical distribution, adherence to Good Distribution Practices (GDP) serves as a cornerstone, ensuring the integrity and safety of products across the entire supply chain. Within the European landscape, GDP guidelines meticulously outline the roles and responsibilities of key personnel involved in this pivotal process. A nuanced understanding of these directives

Every project has its pitfalls, and this is also the case for a Manufacturing Execution System (MES) implementation project. The implementation of electronic batch records is not an easy job, and we will therefore share some pitfalls in the following blog in order to set your team up for success. 1. Scoping The implementation of

In the ever-evolving landscape of supply chain management, one trend gaining traction is the reduced testing of incoming materials. This approach, while initially counterintuitive, offers several strategic advantages that can lead to significant improvements in efficiency, cost savings, and even quality assurance. Here’s a closer look at why more pharmaceutical companies are considering this shift

Introduction As described in cGMP regulations (21 CFR 211.160 & 211.165), laboratory testing of components, containers & closures systems, in-process materials, bulk- and finished products is mandatory to ensure product quality and patient safety. Tests will be performed as described in previously defined specifications, and if a result falls outside of the specification limits or

In the dynamic landscape of pharmaceutical manufacturing, ensuring quality, safety and efficacy of medicines is key. One of the tools to ensure this is the Annual Product Quality Review (APQR also known as APR or PQR), it is a critical process mandated by regulatory authorities and embraced by industry leaders. In this blog we delve

The quality, efficacy and safety of the medicinal product depends on many factors of which we’ve already tackled a few in previous blog posts. The one we will be talking about this time is supplier qualification of excipients. Supplier qualification is a very broad term for the qualification process used to determine whether the starting