Journal Articles
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.
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.