Olivier

Equipment qualification for the introduction of a new production line: Tips and tricks

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 […]

Equipment qualification for the introduction of a new production line: Tips and tricks Read More »

ISO 13485: the bible for quality assurance in the medical device sector

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

ISO 13485: the bible for quality assurance in the medical device sector Read More »

The position of a Responsible Person and Designated Person within pharmaceutical distribution

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

The position of a Responsible Person and Designated Person within pharmaceutical distribution Read More »

Reduced Testing in Supply Chain Management: A counterintuitive Shift?

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

Reduced Testing in Supply Chain Management: A counterintuitive Shift? Read More »

Handling of Out of Specification (OOS) results

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

Handling of Out of Specification (OOS) results Read More »

Maximizing Excellence – The Importance of Annual Product Quality Reviews

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

Maximizing Excellence – The Importance of Annual Product Quality Reviews Read More »

Technology Transfer in Pharmaceutical Manufacturing

In this blog a high-level introduction is given to technology transfer in pharmaceutical manufacturing. Technology transfer is the collaborative process for the directed dissemination of scientific findings, knowledge and intellectual property from the inventors to a receiving party. Specifically in pharmaceutical industry it plays an important role within product life cycle management, from drug discovery

Technology Transfer in Pharmaceutical Manufacturing Read More »

The Art of Auditing in the Life Science Industry: An In-Depth Look through the Eye of a Lead Auditor

Introduction In this blog post, our colleague Lars Pinxten, lead auditor with +10 years of experience in the pharmaceutical industry, takes you through the challenging world of auditing. From understanding the concept of first, second and third party audits to sharing practical tips and tricks for a successful audit. Why Audits? Audits act as valuable

The Art of Auditing in the Life Science Industry: An In-Depth Look through the Eye of a Lead Auditor Read More »