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.
October 07, 2016
Hot topics at CPhI
by Paul Moran posted in LIMS, Data Management, News, Data Integrity, MHRA Guidance, FDA, MHRA
February 18, 2016
MHRA Guidance for Specials Manufacturers
by Andy Mooney posted in LIMS, News, environmental monitoring, unlicenced specials, MHRA Guidance, EU GMP Annex 11 and 15, GMP requirements, radiopharmaceuticals, Product Quality Review (PQR)Manufacturers of specials have guidance to consult as the Medicines and Healthcare Products Regulatory Agency (MHRA) has released an interpretation of GMP requirements for manufacturing unlicenced specials. The guidance titled, "MHRA Guidance for Specials Manufacturers," is presented in a question and answer (Q & A) format for ease of reading and reference. The Manufacturing Specials (MS) licence includes radiopharmaceuticals. The following is selected advice, however, the 41-page guidance is extensive and covers many issues relating to specials manufacturing.