Time passes by but the regulatory uncertainty in the US market shows no sign of ending.
Chris Allen, Managing Director of Broughton Laboratories, is pleased to present at Keller and Heckman's 2nd Annual E-Vapor and Tobacco Law Symposium in Irvine, California on February 6-7, 2018. This comprehensive 2-day course will address regulatory issues relevant to e-vapor, e-liquid and deemed tobacco product manufacturers, distributors, and retailers.
The FDA has issued its latest guidance to the tobacco product industry, including Electronic Nicotine Delivery Systems (ENDS).
The guidance details the following deadline extensions:
One of Europe's leading nicotine product conference is in London this week. Head over to Millenium Gloucester Hotel London Kensington to catch up on the latest industry trends and regulatory updates. Broughton Laboratories is exhibiting amongst other industry-leading companies who support nicotine replacement therapies. The programme is full of compelling topics from consumer trends to the latest market innovations, and our Managing Director, Chris Allen, will be presenting on Tuesday, November 14th at 16:40. He will share with attendees how you can Enhance Customer Satisfaction Through the Quality of Your Nicotine Containing Products. Check out the full programme here, and visit our blog in the next few days to get a post-show update.
The Broughton team has just returned from a busy week in Frankfurt at the annual CPhI Europe conference. We held numerous meetings with existing and potential new clients, and we would like to share with you the top three recurring industry themes at the conference.
I began my placement in Broughton Laboratories at the start of April and the last 6 months has flown by. After going through some basic volumetric and mass measurementtraining, reading a lot of Standard Operating Procedures and learning about Good Manufacturing Practice (GMP) in a working environment, I was put to work. I gained hands on experience in
Is a trip to Frankfurt in your October plans?
Broughton Laboratories are delighted to be exhibiting at the Royal Society of Chemistry Stability Challenges III Event.
At the start of June, Broughton Laboratories began work with the new Vanquish Flex – Thermo Fisher Scientific's latest UHPLC instrument. With pressure capabilities of over 1000 bar, this equipment is a dream for any analyst doing routine HPLC work. When put through its Performance Qualification (PQ) tests, %RSD values of 0.1% were achieved for peak areas. This instrument – clearly accurate and precise enough – had endless possibilities for use in our lab and we were looking forward to testing it out.
On Friday, July 28th, the FDA issued a press release announcing the new plan for tobacco and nicotine regulation. There has been much heated debate between congress, regulators, retailers, and manufacturers since the agency first released regulatory guidelines in May 2016. Through collaboration and discussions, the FDA have shared their concerns, and they are aiming to reach the right balance between regulation and supporting innovation. In order to do so, they have agreed that the industry needs more time to provide proper scientific and regulatory data. Therefore, the agency will update their guidance proposing revised timelines as follows:
Broughton Laboratories have just taken delivery of the new Vanquish Flex from Thermo Fisher Scientific to put the system through its paces in a ‘real-life’ environment. Working in collaboration with Thermo Fisher Scientific, we will be looking to vastly improve the efficiency of some of our most common HPLC methods.
Broughton Laboratories, an MHRA and FDA inspected GMP analytical services laboratory that has been testing Nicotine products since 2010, will be exhibiting at the ENDS conference on 14 – 15th June 2017.The venue will be the St James’ Court Hotel in London.
Broughton Laboratories hosted an NSPCC Bake Day in memory of Linda McCausland at our Laboratories. The NSPCC a leading children’s charity fighting to end child abuse was close to Linda’s heart.
FDA Announced on 3rd May, 2017 that all outstanding compliance deadlines for PMTA have been extended by 3 Months
We are delighted to announce that Broughton Laboratories, a MHRA and FDA inspected GMP analytical services laboratory will be exhibiting at the Making Pharmaceuticals exhibition on 25-26th April 2017. The venue this year is the prestigious Ricoh Arena in Coventry.
Dissolution testing is a well-established method for determining if a product will release its active pharmaceutical ingredient within specified time limits. Many manufacturers utilise the methodologies described in the various pharmacopoeias, with the British Pharmacopoeia being prevalent for products being released onto the UK market.
You've installed your chromatography data system in your laboratory, you've implemented user access controls and audit trails…..job done? Well, you're part way there.
The past couple of years have seen a significant increase in expectations from the regulatory bodies regarding Data Integrity within the pharma industry and has culminated with clearer guidance from the MHRA, FDA and PIC/S. Most companies are aware of the regulations and have taken significant steps forward in ensuring their computerised systems are compliant. There is however a common trend for companies to focus on one set of guidelines. In fact each set of guidelines should be used in harmony to design, deploy and validate your systems.
Photo by: R&D Magazine
Leslie Henderson, our Operations Directory at Broughton Laboratories, became a co-guest writer on R&D Magazine with Darren Barrington-Light Software Marketing Specialist, Informatics & Chromatography Software at Thermo Fisher Scientific.
Introducing the Laboratory News' February Edition. Our Founder Dr. Paul Moran is leading the way regarding the importance of a culture of quality in ensuring data integrity!
Read it here: http://hubs.ly/H06gTvx0
Broughton Laboratories is pleased to announce the appointment of Linda McCausland as Operations Director for the Pharma Services sector. Linda brings a wealth of experience having previously held the position of Director of Analytical Services at Almac and will take on the responsibility of routine/development analytical services and stability storage.
It was the same conference last year where many in the vaping industry realised that changes were coming with regards to the regulations. One year on and there has undoubtedly been a huge shift in attitudes and the realisation that the TPD has not been as restrictive for the industry as first feared. The 2016 event provided a valuable insight into the positive and negative impact of regulations along with how the industry is likely to evolve.
With only a couple of weeks left until the 19th of November we have helped many clients ensure their products are TPD compliant and we are still seeing a significant number of enquiries from both new and existing clients.
The MHRA have remained firm with regards to the deadlines but we have seen many companies look to utilise the sell through period to minimise disruption to their supply chain. Within the guidance for retailers (here) non-compliant stock (manufactured before the 19th of November 2016) may still be sold up until the 19th of May 2017, providing a notification for the non-compliant product is made. The most recent guidance from the MHRA states:
“Great things in business are never done by one person. They are done by a team of people.” - Steve Jobs
For immediate release:
Following continued growth of our business we are currently recruiting for Analytical Chemists to join our Pharmaceutical QC Batch Release team. Broughton Laboratories Limited is a growing independent analytical laboratory servicing the pharmaceutical and healthcare industries. With an advanced range of equipment and state of the art facilities we are now presenting a great opportunity to join our team and become part of our success story.
We have just announced via email to our followers regarding further clarification from the MHRA. Subsequent guidance has been provided by the European Commission regarding the common notification format for the submission of data for the TPD. As with any regulatory process there is always further interpretation required but this information is certainly welcomed and provides more in-depth guidance.
Since the issue of the EU Tobacco Products Directive of 2014, many counter arguments have been put forward against certain aspects of the new ruling relating to e-cigarettes, such as the banning of advertising and certain restrictions of product design characteristics. Since the challenges have been submitted, Electronic cigarette manufacturers and their supporting partners such as emission testing laboratories have been awaiting judgement on the validity of the rules, to be decided by the Court of Justice of the European Union (CJEU). On the 23rd of December 2015, the Court of Justice of the European Union issued a press release outlining the Advocate General’s Opinions in Cases C-358/14, C-477/14 and C-547/14.
The Next Generation Nicotine Delivery 2015 Conference in London a few weeks ago was an invaluable event for the industry. A lot of the concern and tension was alleviated at the event when a presentation was given by Beryl Keely of the MHRA. I don’t think anyone envied her position when there is still much confusion relating to the implementation of the Tobacco Product Directive (Article 20). Beryl’s presentation still left some questions unanswered but highlighted the pragmatic approach that the MHRA are taking to support the industry via the ‘light touch’ approach to regulations.
This article takes a look at a recent FDA warning letter which highlights poor practices in relation to the integrity of electronic data. Broughton Laboratories have invested significantly in computerised systems over the past few years, not only to maintain regulatory compliance but also to provide a system (LabHQ) that add value to our clients.
We are pleased to announce the promotions of two of our team members into new roles:
Rebecca Whiting - QC Laboratory Manager. Beccy has taken position to support Yvonne MacLeod (Technical Manager) with the operational processes of the QC Laboratory. Beccy understands the needs of our clients, the core values of the business and excels in the training of analytical techniques which puts Beccy in a great position to facilitate the growth of the QC Team.
Broughton Laboratories are pleased to announce a further extension to our ICH Stability Storage capabilities. An increase in demand for long term stability storage under Zone IVb conditions used in support of stability programmes for hot and humid regions has resulted in the addition of further 3000 litres of storage space at the 30°C/75%RH condition.
Due to continued expansion further opportunities have arisen within Broughton Laboratories to perform the transfer of new Quality Control contracts and subsequently support on routine finished product analysis. We are currently looking to fill the following roles: