Questions and Answers
Every month we will publish a new Q&A session, these are the past sessions.
Q & A on Nitrosamines
In this Q&A session with Thurloch O’Criodain, we address some of the question industry has in relation to the regulation around Nitrosamines. With the deadline for compliance fast approaching we look to offer practical advice to support compliance.
Pharmalex has available a risk assessment tool and the associated expertise to draw conclusions from the obtained information. This tool can assist Marketing Authorisation Holders and manufacturers to identify the causative factors that could lead to nitrosamines being present in the drug product, and the level of risk. Pharmalex can also provide a review service in relation to risk assessments already carried out in order to provide confidence that those assessments are valid.
The tests require specialised equipment: GC-MS, LC-MS, and LC-MS/MS. The qualification of the equipment has special requirements. The establishment of limits and the test method validation are dependent on the API in question. Pharmalex has available the expertise to help manufacturers develop a test strategy, including
- Selection and approval of contract laboratories
- Instrument qualification and method validation requirements
- QA controls associated with the testing
Swissmedic, the South Korean authorities and Health Canada each require risk assessments to be carried out and testing to be done based on the conclusions of the risk assessment. FDA has not asked for risk assessments but are themselves reviewing all filings based on their understanding of the risk factors involved. FDA are also pursuing any companies and products where they see a risk. Pharmalex has available the expertise to assist companies in addressing the concerns of these authorities in relation to nitrosamines.
All new MA applications should include the risk assessment, and dependent on the conclusions of that assessment, it may be appropriate to build it into the process validation, especially for the API manufacturing process. As with the risk assessments for existing products as mentioned above, Pharmalex can provide expertise and assistance in that regard.
PharmaLex can support companies in making sure that they understand the regulatory requirements in relation to nitrosamines, that their risk assessment is valid, that they are carrying out appropriate testing, and that they are interpreting the information correctly.
There is also an opportunity to gather further information by viewing your recent webinar https://www.pharmalex.com/webinar-risk-management-nitrosamines-regulatory-expectations/
Q & A with Kate Coleman
I was interested in joining PharmaLex as I had worked with them when I was in industry and knew that their priority was providing robust solutions to some of the common challenges currently facing the Pharmaceutical Industry. PharmaLex brought a practical hands-on approach to issues and challenges and gave our team a different perspective. Joining Pharmlex gave me the opportunity to really use my experience while still providing me with many learning opportunities to expand that experience. I love the variety in my role and working with many different people in the industry.
My undergraduate degree was in Industrial Microbiology and my Microbiology knowledge and experience underpins everything I do. This foundation has been invaluable when working with clients involved in Steriles, Biologics, Vaccines and ATMPs. I also have an MSc in Pharmaceutical Quality Assurance which expanded my Pharmaceutical education and allowed me to branch out from Microbiology into other areas of Pharmaceutical Quality. This MSc included a Thesis on Quality Risk Management which is now an area of expertise for me and something I am known to be passionate about!. I also have a Post Graduate Diploma in Manufacturing Technology which allows me to be recognised as a Qualified Person in the EU and I have enjoyed my time as a practicing QP.
The landscape is changing in the Pharmaceutical industry as we start embracing novel technologies and I’m fascinated by personalised medicine and the impact these types of novel technologies will have on many traditional areas such as QC, QA, Sterility Assurance, Risk Management and QP disposition.. The direction the industry is taking will challenge all of us to move out of our comfort zones and that sort of challenge is always exciting. Also, the continued focus on Quality Risk Management continues to highlight the interdependencies between all the processes and systems in a pharmaceutical facility and working in this more holistic environment is very exciting when compared to the historical approach to Quality which was more siloed and removed from the heart of the pharmaceutical process.
With any change comes uncertainty and the biggest challenge I see in the industry is overcomplication of processes and procedures and a move away from effective simplicity. I often see very complicated processes and procedures that have become far removed from the basic principles of Quality or Risk. The challenge for the industry over the next number of years will be to peel away the complexity in areas where it isn’t required and become comfortable again with processes and procedures that are scientifically sound but easy to implement, follow and maintain. Unnecessary complexity becomes a burden and can be very difficult to manage long term.