Blog & Article
- 7th May 2024
Journal Articles
Journal Article
Quality control (QC) is a fundamental aspect for assuring the safety and efficacy of medicinal products. Testing of drug substances (DSs) and final drug products (DPs) is performed at intermediate manufacturing stages to confirm that they meet established specifications as defined in a marketing authorization. This does not differ for advanced-therapy medicinal products (ATMPs).
Journal Article
Assay development doesn’t end with a validated analytical method. Changes are made as a biopharmaceutical product continues through development. Often that progress includes transfer from the original laboratory to another. Whether a project is outsourced or scaled up in house, analytical methods such as bioassays must be transferred to new laboratories, with different personnel and often different equipment setups.
Journal Article
A webinar hosted by Biopharma Excellence featured an in-depth discussion on the ways that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.
Journal Article
Biopharmaceutical products must be sterile. Protein biologics and now advanced-therapy medicinal products (ATMPs) usually are administered in ways that bypass patients’ natural immune defenses.
Journal Article
Life-science companies must stay on top of new requirements, innovations, process improvements, and potential roadblocks to navigate complexities across the development, manufacturing, and regulatory life cycles of their products.
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
Pages 14 – 15. Change management offers a broad, system-wide perspective that includes the oversight and management of all changes and the change process. Michelle Anastasi from PharmaLex explores what good change management looks like and who should be involved.
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.