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.
1. Brexit Uncertainty. Does anyone know what is happening?
A hot topic on everyone’s agenda was ‘Brexit’ and the implications this may have on the supply chain of pharmaceutical products. The current feeling is that this is going one of two ways (i) a ‘hard exit’ in that the UK would be seen as a ‘third country’ to the EU and vice versa, or (ii) a mutual recognition in which very little changes.
Prior to, and during CPhI, we held discussions with many companies about their plans for addressing Brexit. Some companies are concerned about business continuity, and we have subsequently provided support through our method transfer process at our UK facility. This gives companies the option for additional capacity and supports both possible outcomes of Brexit.
In the event of a ‘hard exit’ any product entering the UK from a ‘third country’ is likely to require re-testing. This would be a huge undertaking for the industry, and therefore starting now will ensure that the product supply chain wouldn’t be compromised. In the event of a mutual recognition (the preferred option for many) the testing data would be valid for both the UK and EU, providing much needed support on capacity increase and business continuity.
The stance of Broughton Laboratories is that we will continue dialogue with the industry and regulators in order to support our current and potential clients, whatever the outcome.
2. How to expand internal QC capabilities to meet the growing demands of manufacturing?
Very positive news that healthcare manufacturers are expanding facilities to cope with the increasing demand for high-quality and cost-effective medicines. Many manufacturers have internal QC laboratories for batch release testing; however, expanding the QC facilities (which is highly labour-intensive) at the same pace as manufacturing demands, is challenging.
QC Laboratories must support on-going production and continuous improvement initiatives. Add the new data integrity regulations to the QC responsibilities, and it is not surprising that stakeholders across the supply chain operations are concerned. Using an outsourcing partner who specialises in analytical services can provide the required QC services to support the immediate growth of production. Companies can purchase trained FTE heads/teams from their outsourcing partner in a fraction of the time it would take to recruit and train new headcount to GMP standards. This helps production to maintain supply chain continuity during high growth periods and allows the internal QC team to increase their capacity in a controlled manner.
3. Data Integrity. How can I be sure of a clean bill of health during my next inspection?
Data integrity is still a hot topic with regulatory pressure increasing. Did you know that the latest MHRA guidance states: "It is expected that facilities should upgrade to an audit trailed system by the end of 2017?" It goes on to state "It is acknowledged that some computerised systems support only a single user login or limited numbers of user logins. Where alternative computerised systems have the ability to provide the required number of unique logins, facilities should upgrade to the appropriate system by the end of 2017."
Big Pharma companies continue to feel the huge impact of adverse regulatory inspections – every CEO’s nightmare which impacts on the whole organisation. With this in mind, it has never been more important to deploy systems designed to comply with regulatory requirements. This one is not going away so the message is – act now.
As always, CPhI continues to be a wonderful learning opportunity and an excellent forum for healthcare professionals to collaborate on shared future goals. See you all next year in Madrid.