Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
Interview with Doan Tran
Interview with Doan Tran, Process Development Scientist, Bayer Pharma, Germany
1. What is the reason behind the increased interest in continuous processing procedures? What are the main benefits?
As rules and regulations become more stringent and competition increases, continuous processing becomes necessary in order to ensure things are done right the first time. The greatest benefit of continuous processing is getting instant results, leading to better control over our processes before manufacturing is completed. Additionally, it increases process understanding and gives results for better decision making. Ultimately, this keeps a company competitive as it reduces time and cost.
2. Are all procedural steps designed and well established already? How far are we from the ideal construction?
We have PAT and QbD, which are relatively new to the pharmaceutical industry. I would say we are starting, but not yet at the ideal construction, if we are speaking of the industry as a whole. I believe it will take some time for the ideal construction to be reached.
3. How should this approach be implemented into the company practice? What are your experiences?
Implementation is difficult because many changes need to be made to documentation, equipment, state-of-the-art technology, etc. It’s best to change things gradually. Currently, we are facing many of these changes. We are not only ensuring continuous processing but also increasing knowledge. Due to continuous processing, we are able to decrease the time required for our processes, which can be used for more beneficial tasks, such as analyzing data, instead of constantly solving problems.
4. Is it relevant only for upstream professionals?
No, because continuous processing provides lean processes with an increase in results and knowledge; therefore, this procedure can flow downstream as we go about its implementation.
5. What are your research steps in the case of development of other fermentation techniques?
This is accomplished through seminars and other functions within the company, such as the technology group.
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
Attendees will be introduced to comparability in biosimilar development, the analytical strategies of protein characterization of biosimilars, the structure of proteins, in vitro pharmacology and much more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.
Driving the national agenda of Medical tourism through PX Excellence
Read the interview with Dr. Layla Al-Marzouqi, Director of Medical Tourism Council at Dubai Health Authority, and learn how to enrich patient experience and quality of healthcare.
No more trouble with dangerous good shipments
Global temperature controlled pharmaceutical shipments are constantly faced with new logistics challenges and regulations. This January 2017, IATA Dangerous Goods Regulations added further complexity to shipping cold chain products compliantly.
5 Changes in Signal Detection Management
The European Medicines Agency, regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals. A safety signal is generally defined as information about a new or known Adverse Event that may have been caused by a medicine, where it is therefore necessary to conduct further investigation. Evaluation of safety signals plays a major role within pharmacovigilance. Therefore, it is vital for regulatory authorities to know the latest updates detailing the risks and benefits of medicines. The EudraVigilance database is an important source of information on suspected adverse reactions and signals.