Journal Articles

Journal Article
Development of cell and gene therapy (CGT) products is often challenged by the need to demonstrate product comparability following changes in the manufacturing process. Issues include limited process and product knowledge at different stages of product development compared to more conventional biotherapeutics, the complex mechanism of action, the limited and sometimes variable nature of the starting materials, and analytical methods which are often still in development during a comparability study.
Journal Article
Page 32 -Think of regulators as allies. They share the goal of bringing life changing medications to the patients that need them and are partners in development. Meetings with regulators should, therefore, not be seen as discussions to avoid or as hurdles to overcome but as opportunities for sharing critical information and gaining alignment
Journal Article
Pages 31-32. According to the American Society for Quality, a quality management system (QMS) is a “formalized system that documents process, procedures, and responsibilities for achieving quality policies and objectives”. For companies in life science and pharmaceutical, maintaining a health QMS is crucial for ensuring compliance and adequate preparation for inspections.
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
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.
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