The Medicines and Healthcare products Regulatory Agency (MHRA) has a responsibility to protect public health by ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. Each year, they conduct
Computerised Systems: A Summary of 2016 MHRA Inspections
by Theresa Webster posted in Data Integrity, audits, MHRA, GMP requirementsIs My Audit Trail Regulatory Compliant?
by Theresa Webster posted in LIMS, Data Integrity, audits, FDA, MHRA, GMP requirementsOperating a laboratory within regulatory requirements can be a challenge. The wording of regulations is typically cryptic, and there’s always room for different interpretations. Audit trails are an important factor for compliance because
Hot topics at CPhI
by Paul Moran posted in LIMS, Data Management, News, Data Integrity, MHRA Guidance, FDA, MHRAThe 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.
PIC/S Data Integrity Draft Guidance Issued Last Week
by Paul Moran posted in News, Data Integrity, pharmaceutical manufacturing, FDA, MHRABroughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance:
MHRA Creates Draft GxP Data Integrity Guidance
by Paul Moran posted in Data Integrity, GxP, MHRAIn breaking news today, the MHRA just released a new 14 page consultation document for data integrity. As quoted from the MHRA:
Environmental Monitoring - Why Does It Matter?
by Andy Mooney posted in LIMS, Data Management, environmental monitoring, pharmaceutical manufacturing, microbiological contamination, standard operating procedures (SOPs), FDA, MHRAMicroorganisms 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.
Return on Investment: Beyond the Regulatory Benefits of LIMS in a QC Lab
by Andy Mooney posted in LIMS, Data Management, Client Expectations, Data Integrity, MHRA, process mapping, Return on Investment,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.