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.
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.
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.
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?
A LIMS can help businesses meet regulations.
Yorkshire, UK (May 19, 2015) - On 17th of March, 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) released the newly revised and updated GMP pre-inspection compliance report templates and guidance. The newest format of the report includes guidelines for the inclusion of data integrity policies that will now be added in order for compliance to be met.
On 17th of March, 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) released the newly revised and updated GMP pre-inspection compliance report templates and guidance. The newest format of the report includes guidelines for the inclusion of data integrity policies that will now be added in order for compliance to be met.
Strategic decision-makers, QA and QC Laboratory Management, and IT professionals often ask whether they need a LIMS by 2017. Compliance with regulations is key to the decision along with managing customer expectations. Scott Schaefer writes in the Harvard Business Review that making good business decisions rests on assessing how the potential benefits and costs of a particular strategy pertains in each situation.
World number one Rory McIlroy will be joined by the golfing greats as he hunts down history as well as his first Green Jacket when he steps out on to the first tee at Augusta National today, the home of the US Masters, the first of four major championships in professional golf. The return of four-time champion Tiger Woods has already heightened expectations around a tournament that needs little hyping. Jack Nicklaus has the most Masters wins, with six between 1963 and 1986. Arnold Palmer and Tiger Woods have won four each, and five have won three titles at Augusta: Jimmy Demaret, Sam Snead, Gary Player, Nick Faldo, and Phil Mickelson. For the non-golfers, scoring the number of shots taken to complete a round of golf is not complicated, but current golfing regulations only permit hand-written records and signatures. As with many manual systems, mistakes can happen and can be costly.
Before, computers and software data management in laboratories was a tedious and time consuming task. With handwritten reports and charts, there was a higher probability of human error to occur. Laboratory information management systems (LIMS) were only first developed in-house by the early 1980s. In 1982, the first generation commercial LIMS was created providing the first automated reporting features. By assigning laboratory functions to a centralized computer, productivity and functionality improved.As technology advances and work flow changes, the need for application specific features emerged. This initiated the development of second generation LIMS which was possible by using third-party commercial relational databases through the use of minicomputers. By the early 1990s the first client/server configuration was developed using a PC combined with the security of a minicomputer. Functionality “appeared” quicker by splitting the data processing between several clients and the main database server.