LIMS (Laboratory Information Management System) is becoming more and more crucial to ensure quality control and assurance in laboratories, because most analytical activities within a modern lab work to support the process control function, and QC is vital for that.

Currently, advances in IT and LIMS products are simplifying QA/QC through the computerization of: data entry from instrumentation, test result data specification review, assignment of lab activities and workload, and management analysis and reporting.

LIMS offers many advantages to the lab when trying to reinforce QA/QC controls such as:

-    Personnel qualification and training
-    Labeling, storage, and expiry of reagents, solutions and hazardous chemicals
-    Equipment documentation, calibration and validation
-    Integration of lab instruments and systems
-    Labeling and tracking of samples
-    Standard operating procedures and their use
-    Analytical method validation and documentation
-    Computer software validation
-    Records of deviations from lab procedures
-    Determination of the right QC controls, which deal with the daily quality of analytical data developed

LIMS can define specific lab personnel and their particular working environment, defining the activities they can perform and information they can access.  It offers a way to allow users to be approved to do certain functions, and the access can be limited to the information each user requires to do their job.  LIMS also computerizes the production of bar code labels when a sample is logged in, and permits the definition of storage information, like location and storage conditions, against the logged in sample.

LIMS allows for the tracking of instruments, systems, and equipment used in the lab.  It can be programmed to automatically flag and remove from operation the instruments that need regular service and calibration.  After analytical methods are defined in it, LIMS allows for the storage of the whole method description against its entry.  Each method can be programmed to show changes through time and to ensure that only the latest method is used.  Review and approval by different persons can be required before using the method.

LIMS can identify deviations in work practice and analytical data for tracking and reporting purposes.  It allows users to easily record and deal with unexpected events that inexorably happen in a lab, like sample breakage.  It can be merged will all principal instrument types in the laboratory to process results faster and to reduce errors in manual transcriptions.  LIMS has audit trailing mechanisms to record, track, and justify changes in lab data, and some even allow for the auditing of any item and the automatic sending of notifications to key individuals.

It is vital to ensure that the electronic data submitted to regulatory agencies is trustworthy, reliable, authentic and legal.  In order to comply with the 21 CFR Part 11 rule, LIMS has to provide a way to specify identification of regulatory data with the lab, audit trail mechanisms for regulatory data, security controls on the data, and mechanisms for signing electronically the regulatory data entries. This has promoted the cooperation of LIMS vendors and pharma companies to develop solutions that fully comply with this rule.

These are only some of the characteristics of LIMS that can help laboratories control and analyze data; there are many others. However, although LIMS offers a computerized secure framework for inputting, processing, and reporting information, as well as an important contribution for labs to comply with the changing regulatory requirements, it is only a part of the solution.  Pharmaceutical consultancy firms reinforce the fact that there must also be a thorough knowledge of the regulatory requirements and comprehensive QA/QC procedures.

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If you go back to the latter part of the 20th century, the pharmaceutical industry was very vocal about the challenges of operating a global business successfully, in an environment of often regional GMP regulations.  In an attempt to harmonize these practices, an informal ICH working group, in July 2003, agreed on a vision to develop a pharmaceutical quality system that would be applicable across the entire life cycle of a product.  They wanted to emphasize an integrated approach to quality risk management mixed with science.  But did they achieve their goals?

What the committee wanted to achieve was the ability to focus on the entire life cycle of the product, not just manufacturing.  Because the linkage between development and commercial manufacturing is so critical to the successful introduction of a product, and the successful transfer of knowledge, there was no doubt that something had to be done.  In the end the EWG wanted to augment regional GMP regulations and move from GMP compliance to robust process understanding.  Any good pharmaceutical consultant will tell you that knowledge management, knowledge transfer, and technology transfer, are key aspects of Quality Systems Management.

There has always been a fear in the industry that too many companies were taking commercial GMP requirements and forcing them upon development and manufacturing activities.  That is why it is so important for the elements of the new system to be applied in a manner that is appropriate and proportionate to each product life cycle stage.  This is why the old system was broken, because it failed to recognize the fact that the goal of development is oftentimes much different than the goal of manufacturing.

However, these new guidelines do not replace existing GMP regulations, but rather are used in accordance with the existing regulations.  Because regional GMPs don’t necessarily address all stages of the product life cycle, nor promote innovation or continual improvement, it is important to take this overall step towards a more quality controlled environment.  Under the new quality control system, the system encourages more use of science and better use of risk-based approaches at every stage of the life cycle.  Using this new system promotes better quality and initiates continual improvement across the product life cycle, resulting in better quality.  By using innovative methods like these, there is no doubt the pharmaceutical industry is well on its way to achieving the kind of process control and quality that is expected in the 21st century quality system approach.

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The U.S. life sciences industry is a business sector which faces the significant task of developing, testing and manufacturing pharmaceuticals.  Due to the complex environment in which pharmaceuticals are developed, there is a strong need for IS and other quality systems to monitor, manage and control the production processes.  The quality systems can drive each of the steps with the product life cycle and is a critical factor for guaranteeing that the optimum quality standards are met.

The FDA plays an important role in this systematic testing process by applying rigorous oversight to the pharmaceutical industry, to ensure high quality standards, efficacy, and the safety that the general public demands.  Throughout the research, development, and the manufacturing life cycle of drugs, vaccines, and other biopharmaceutical products, the FDA’s role is that of a principal supervisory agency.  Their job is to assure that optimum quality is being achieved, and the best practices are being followed.

So how can you prepare your bio-pharmaceutical company for one of these surprise inspections?  Well, one thing you can do is to hire a life sciences consulting firm that specializes in the development of quality systems, in which they can design, or redesign your entire system, to meet FDA regulations.  The FDA uses it’s oversight to guarantee that such issues and problems with contaminants and failed processes are quickly sniffed out and identified.  Without the help of an experienced consulting firm, your company may fail to take the preventive actions necessary to successfully pass an FDA audit.  Because of the severity of the consequences in developing possible faulty pharmaceutical products, the FDA has very little tolerance for variability or deviation from its quality inspection regulations.  This means if your products do not pass this FDA quality inspection, you will be shut down, and shut down fast.

The pharmaceutical industry, like any traditional manufacturing industry, uses traditional, older production processes and many companies have outdated information systems.  In the past, the work flow in the pharmaceutical industry was optimized for straightforward production including cost reductions, rather than focusing on transparency and quality production.  Furthermore, even though many pharmaceutical companies are starting to catch up to the rest of the manufacturing industry, and have begun to develop more sophisticated systems, many companies wouldn’t be able to pass a simple FDA regulatory inspection if they had to.  If you want your company to be properly prepared, talk to a pharmaceutical consulting firm that specializes in quality control, and they will be able to prepare your company properly in case of a surprise FDA inspection in your company’s future.

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The Pharma industry is facing extreme change.  Gone are the days when pharmaceutical manufacturers made million in profits no matter the times.  Today’s challenges are transmuting the field’s reality for the future: expiration of blockbuster drug patents, a decreasing pipeline of blockbuster drugs, pressure from generics, doubt about the future of healthcare compensation, mergers and acquisitions.

This somber panorama is moving Pharmas to evaluate the best ways to combine and manage themselves while urging external organizations to do the same in order to continue being competitive.

To maximize their profits, Pharmas are scanning their activities to achieve optimization, efficiency, and quality amid the crisis.  Manufacturing is in this scope, as companies try to lower costs throughout every area, prompting bold manufacturers to expand their Lean Six Sigma enterprises with predictive modeling techniques, to earn new perception, and encourage change within the organization.

For many years, the Pharma industry has been characterized for being delayed in manufacturing efficiency and productivity, specially because it is very expensive and involves a great deal of work to comply with regulatory principles, which call for revalidation of processes after a change.  This has established a road of inefficiency, waste, and lack of quality control.

Until now, pharmaceutical manufacturers had not had any economic motivators to support change, and now they face the consequences.  Luckily, in recent years, they have received some support from the FDA and other regulatory bodies, which recognize the lack of efficiency and quality control and have backed up a “quality by design” model to substitute the previous one of “quality by test results”.

The FDA has established the Process Analytical Technology (PAT) initiative, which aims at guiding pharmaceutical manufacturers towards consistent, predictable, and higher quality levels.  By accepting PAT, Pharmas are changing their focus to two management approaches: Lean manufacturing and Six Sigma, with the intention of reducing waste to meet customer demand and market changes, and to lessen the variation in products and processes, to avoid product defects.

Lean and Six Sigma are powerful tools to improve quality, compliance, productivity, costs, and speed, allowing for the Pharma to provide better products in a cheaper and faster way.

But it doesn’t stop there.  To effectively leverage PAT and Six Sigma, pharmaceutical manufacturers must use modeling tools that improve quality even before a product is manufactured.  They require predictive analysis that gives them information about the impact of numerous changes, in ingredients or processes, on the quality of the end product.  The Monte Carlo simulations is such a tool.  It uses probability distributions as process inputs, instead of one value.

In this way, pharmaceutical manufacturers can predict the quality of a product more accurately, thus, balancing the quality demands of Six Sigma against Lean principles, that aims to manufacture products faster and cheaper.  It may also help in predicting manufacturing demand and cycle periods, as well as the critical steps to achieve the best quality.

Imagine the improvement over current practices of testing quality once the manufacturing process is over!  To get started, research thoroughly the Monte Carlo model and even ask pharmaceutical consulting firms for detailed information on its implementation.

Embracing change today is the way to flourish.  New methods like Lean Six Sigma, supported by prediction tools, clear the path towards a better future and a better company, all for the common good.