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.

Microorganisms are found everywhere. This can be in the air and water, on skin and other surfaces. When microbiological contamination occurs in pharmaceutical manufacturing, product batches are wasted, risking potential recalls and plant shutdowns. The effect of the contamination can include lost time and money for manufacturers, drug delays and shortages, and related loss of public confidence, potential fines and even criminal consequences.

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 4^th and 5^th 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 4-5^th 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.

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 13^th to 15^th 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.

Overheard in the ABC Pharmaceuticals QC lab, "He understands the regulatory benefits of LIMS, but my boss also wants to see a tangible return on investment. Help!"

A major driver for implementing LIMS in regulated industries is the increasing focus of the MHRA, FDA & HPRA on the hot topic of data integrity. Failure to present a quality system that meets the requirements reflected in the ALCOA acronym ( data must be attributable, legible (permanent), contemporaneous, original and accurate) could lead to a loss of licence and result in a devastating impact on revenue.

Broughton Software are delighted to be attending the NHS Pharmaceutical Quality Assurance and Technical Services Symposium at Chesford Grange Hotel, Warwick from 15-16^th September. Following the recent addition of new clients supplying Pharmacy Specials to the NHS, Paul Moran and Andy Mooney will be at the show to listen to attendees’ regulatory challenges and to evaluate how LabHQ LIMS could help to overcome them.

It’s going to be a busy Q4 at Broughton Software with the launch of its latest version of LabHQ LIMS and attendance confirmed at a number of industry events. We are delighted to announce that this will include the number 1 UK laboratory show, LabInnovations which is held at the NEC in Birmingham from 4-5th November. If you are looking for a LIMS system to manage sample test data and assist in compliance with regulatory bodies such as the MHRA and FDA we may be able to help. Our product, LabHQ, is a LIMS for QC labs in a manufacturing or contract test environment. It is designed to streamline the sample test process, generate cost savings and facilitate compliance with the data integrity requirements of regulatory bodies such as the FDA and MHRA

Most Quality Management Systems will have evolved over time. For many this will mean the design and use of custom excel spreadsheets to manage Quality Control test data. With the recent updated regulatory guidelines with respect to data integrity, how compliant are these spreadsheets?