The CPhI conference in Barcelona did not fail to deliver on hot industry topics and trends in global pharma. After meetings with clients, new contacts and industry thought leaders the Broughton team were well placed to gather commercial and technical opinions shaping the future direction, technologies, opportunities and threats in pharma.
Broughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance:
In breaking news today, the MHRA just released a new 14 page consultation document for data integrity. As quoted from the MHRA:
First let’s address implementing change. This could be considered a lifelong study. I’ll cover this succinctly before moving onto problem solving and the root cause analysis pocket guide providing a simple technique for both. If we get the problem solving bit right then implementing change becomes a whole lot easier.
The European Commission has published the final version of the revised EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Deadline for coming into operation is 15th April 2016.
Decreased operational costs, increased capacity, and improved cash flow often follows the implementation of a Laboratory Information Management System (LIMS). Many laboratories have realised savings due to the installation or upgrading of a LIMS, an investment that pays off in the form of both hard and soft benefits. The hard benefits improve cash flow while the soft benefits, such as employee morale and customer satisfaction help reinforce them.
The minutes from the October 2015 MHRA industry consultative committee meeting for GMP & GDP are now available on www.gov.uk.
During an enjoyable, busy and informative CPhI show in Madrid, what did the team at Broughton Software learn?
It was wonderful to see such a great turnout at the UK NHS Pharmaceutical Quality Assurance and Technical Services Symposium 2015. The Symposium included several informative break-out sessions to discuss current key topics facing the industry. Dr. Julian Smith (Viridian Pharma Ltd) and I had the opportunity to host one of the sessions to cover ICH analytical method validation and data integrity.