Blog & Article
- 7th May 2024
Journal Articles
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.
Journal Article
PharmaLex was established 25 years ago with a vision to make a difference to how the industry interacts with regulatory authorities.
Journal Article
Heightened interest in small molecules is likely to continue in 2023 and beyond as several biotech companies look beyond biologics to bring medicines to patients in need.
Journal Article
The European Medicines Agency (EMA) was true to its word in 2022. While pharmaceutical companies involved in manufacturing sterile products were assessing the text of Draft Revision 12 of Annex 1 to the European Union’s good manufacturing practice (GMP) regulations, the final approved revision was published on 25 August 2022 (1), bringing an end to speculations about what it would include.
Journal Article
Efforts to build greater harmonization between global regulators are gathering momentum, partly due to changes brought about by COVID. This growing trend is likely to continue as regulatory authorities gain increasing confidence in collaborative initiatives that are still in their infancy.