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
Operating 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
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Broughton Software received notice that a PIC/S Data Integrity Draft Guidance was released last week. Direct copy has been provided below, including a link to the draft guidance: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:
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.
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.