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.
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.
The minutes from the October 2015 MHRA industry consultative committee meeting for GMP & GDP are now available on www.gov.uk.
The weather outside may have left a bit to be desired but inside the Pavilion at the NEC in Birmingham there was a real buzz about Lab Innovations 2015. Broughton Software were delighted to be part of the UK’s largest Laboratory show that took place on 4th and 5th November and, judging by the number of visitors to our stand, LabHQ LIMS is generating a buzz of its own in the world of Laboratory Information Management Systems. A big shout out to everyone who we met during the show.
With the exhibition season now in full flow, Broughton Software is delighted to be exhibiting at the UK’s number 1 show for laboratory professionals, Lab Innovations. Taking place at the NEC in Birmingham from 4-5th November we are looking forward to meeting Quality Control and QA professionals who are looking for ways to achieve regulatory compliance and generate cost savings in their Quality Control Labs.
During an enjoyable, busy and informative CPhI show in Madrid, what did the team at Broughton Software learn?
Broughton Software CEO Paul Moran and Managing Director Theresa Webster will be accompanied by Commercial Director Andy Mooney at the largest event on the Pharmaceutical industry calendar – CPhI. This year’s event, held in Madrid from 13th to 15th October, marks the launch of version 4 of LabHQ Laboratory Information Management System (LIMS). With functionality to facilitate compliance with the latest FDA and MHRA regulatory requirements, version 4 of LabHQ is sure to generate a buzz during the event.
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.