Blog & Article
- 20th November 2025
Journal Articles
Journal Article
The manufacturing of medicinal products brings manychallenges when it comes to control of contamination. Contamination can present itself as chemical, microbial, particulate or product cross-contamination. Medicinal products such as parenteral, ophthalmic and some inhalation preparations are required to be sterile, i.e. entirely free from undesired living organisms of all types or their by-products. This article delves into contamination control from a microbiological perspective.
Journal Article
In an interview with Pharma Tech Outlook, Patrick Nieuwenhuizen, director and senior consultant at PharmaLex, sheds light on the key strategies and technological advancements driving success in the ever-evolving pharma tech landscape.
Journal Article
Digital innovation is playing an increasingly important role in the regulatory process. As such, it should be an integral part of the outsourcing relationship. Digital technologies are increasingly being integrated into many regulated processes in the pharmaceutical industry. Technology solutions such as artificial intelligence, automation, and natural language processing can now support the pharmaceutical compliance journey.
Journal Article
Pharmaceutical legislation usually describes GxP requirements broadly. Additional regulations, directives, ordinances, and guidelines may provide further guidance for interpretation and implementation, but each organization is unique. Companies differ according to their location, size, facilities, personnel, products, and business activities. affairs department of a pharmaceutical company. As usual, I attended onboarding meetings and received a training plan that contained a list of standard operating procedures (SOPs). So far, so good.
Journal Article
Understanding the needs of your customers and getting them right the first time builds customer satisfaction and a sustainable business strategy. That seemingly simple objective is at the heart of a strong quality culture.
Journal Article
Quality control of medicinal products is a fundamental aspect of assuring the quality, efficacy, and safety of the product. Testing of the product at intermediate manufacturing stages, such as testing of Drug Substance (DS) and on the final Drug Product (DP), are performed to confirm the product meets the established specifications as defined in the Marketing Authorisation.
Journal Article
Change management is integral to ensuring appropriate implementation and maintenance practices for pharmaceutical quality systems (PQS). Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
Journal Article
This article reviews the MEDDEV 2.7/1 Revision 4 requirements, with an emphasis on strategies to meet the individual requirements of specific regulators in one document. Key guidance on navigating the world of Clinical Evaluation Reports and the MEDDEV 2.7/1 Revision 4 are shared.
Journal Article
Now that regulators, subject-matter experts (SMEs), and other stakeholders can observe and review facilities on site, we might wonder what purpose virtual audits serve and what benefits still could be leveraged.
Journal Article
Shifting to a digital regulatory environment is forcing pharmaceutical companies to confront knowledge gaps across key research and development (R&D) functions.
Journal Article
Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
Journal Article
The fields of immunology and immuno-oncology have seen some significant advances and changes throughout the past decade or more, all of which are bringing new hope to patients and healthcare systems. In the next 5 years, these advances are expected to gather momentum amid new scientific and technological breakthroughs.