GLP stands for Good Laboratory Practice. This week we’ll cover Preparing for an Audit, the Consequences of Not Maintaining GLP and what to look for in Software Solutions for Achieving GLP.
Preparing for an Audit
If an audit or inspection is requested, then it’s important to make sure all relevant study information is reviewed and available. Prior to an inspection, the following materials are usually reviewed:
- The GLP regulations
- The Management Briefings Post-Conference Report
- Assorted memoranda and policy issuances
- The GLP Compliance Program
- The protocol of an on-going study, if available
- The final report of a completed study, if available
- The inspection report of the most recent inspection
The Consequences of Not Maintaining GLP
If it is determined a study does not meet Good Laboratory Practices there are a number of consequences.
- The results of the study may be rejected as invalid.
- If study results are included in an Investigational New Drug (IND) or New Drug Application (NDA), the entire submission could be rejected.
- Another consequence could be the issuance of a warning letter by the FDA.
- In more severe cases, fines could be levied against the organization.
Recent examples of fines levied on firms for poor GLP include:
1. A laboratory in North America that was fined over $200,000 for:
- Improperly storing chemicals
- Insufficiently training employees in hazardous waste management
- Failing to notify local and state emergency response officials.
The suspected violating materials were described as "potentially explosive peroxide-forming chemicals" and indicated they were found in three of the organization's local laboratories.
In-house staff provided hazardous waste training to other employees but the staff members providing the training "were never properly trained themselves”.
2. The European Commission threatened to fine a member country $200,000 per day for not setting up standards for implementing safety standards for biotech experiments.
The EU adopted legislation in 1990 requiring member nations to set up emergency plans for dealing with accidents in biotech labs.
GLP Software – Solutions for Achieving GLP
All aspects of R&D can be electronically managed using a number of different software solutions.
Below is a summary of relevant types of software and how they each help you achieve GLP.
Project & Portfolio Management (PPM)
Project & Portfolio Management (PPM) systems help you manage individual projects or studies. Things to look for in a PPM for GLP:
- Offers project managers and team members a single point of access for all project information.
- An easy interface that makes it easy to capture key performance indicators and update metrics
- Easy access to documentation and protocols
- Real-time visibility into project performance through reports and dashboard views.
- Ability to create new projects by importing Microsoft Project files, or by using pre-defined project templates.
- For periodic external reporting, the ability to export the project or study back to Microsoft Project files.
Electronic Laboratory Notebook (ELN)
An Electronic Lab Notebook (ELN) lets you capture all of your study experimental information electronically.
Things to look for in an ELN suited to the GLP environment are:
- Simple Interface that allows scientists to enter information directly into the system
- Allows scientists to import and manage existing data and files
- Templates that ensure consistency in how scientific information is captured and organized
- Integration with scientific tools and equipment
- To allow automated capture of data directly from the instrumentation.
- Publishing that automates the entire notebook publishing and witnessing process.
- Ability with one click to automatically publishes the notebook to a PDF file
- Built in workflow to review, witness, notarize and store the report in a defined library structure
- Records management to securely manage and archive all study information
- Handling of pre-defined business rules that define what information is published, and who reviews and signs the notebook.
- Detailed secure audit trails of the entire process
- Electronic signatures with full CFR 21 Part 11 compliance
Laboratory Resource Management System:
Look for a Laboratory Management System that will allow:
- Materials Management features that let you track laboratory equipment and materials in the lab.
- Material quantities can be tracked
- Aliquots can be defined
- Shipping requests can be managed automatically
- Reports should track the progress of your experiments
- Reports should show information such as a list of all materials that are going to expire.
Quality Management System:
A Quality Management System (QMS) provides a central location for managing all of your quality processes, such as:
- Corrective Actions and Preventative Actions (CAPA),
- Non-Conforming Product (NCP)
- Adverse Events
- Internal and External Audits
- Customer Complaints
Look for a solution that has:
- Out-of-the box workflows based on industry best practices
- Ability to be configured to meet your specific quality process requirements and can scale and grow with you as your organization grows
- The ability to configure each type of quality event to have its own individual workspaces and processes
- The capability of each quality process being electronically managed using workflows and electronic forms to ensure that processes are completed properly and on time.
- Reporting capabilities that simplify the process of reporting, allowing easy, standardized and customized reporting across sources such as NCP, Audits and Change Controls (CCs), Data Ranges, Employees and Project Tasks.
Whichever system(s) you choose to assist with ensuring GLP must include:
- A workflow engine and electronic signature capabilities that ensure that 21 CFR Part 11 compliance can be attained.
- Full audit and version control, along with security and authentication must ensure that any data in the system can be accurately tracked throughout its lifecycle.
Electronically storing all information in a collaborative enterprise web based system ensures that the data is available to those who need the information. Collaborative workspaces provide access to all relevant information in context, making it easy to find the information you need, when you need it. All data is indexed, so searching for information is a simple task. Searches can be performed with multiple options, including full text, meta data (system and custom) and system attributes.
Benefits of Integrated Solutions
The benefits of using a combination of tools above are immediately visible to both end users and management. If the systems are implemented to work together, or if they are part of a single suite of software solutions, it allows for the capture of all the data required to help the laboratory or organization to be GLP compliant. Electronic storage of all data in a central system allows for easy reporting across different domains to ensure that all information is available to those who need it. Efficiency is obtained by automating manual processes with automatic notification to ensure that employees know what tasks they need to perform. Management gains increased visibility through reports and dashboards into all processes and tasks.
The Benefits Organizations Experience by Integrating their Software Systems include:
- Incidents of non-compliance are reduced since information is captured, managed, and tracked as it’s created.
- Deviations and other quality issues are reduced through automation of manual quality processes using workflow capabilities.
- Controlled documents are stored in a central repository with complete version histories and audit trails, ensuring you have all the information you’ll require to respond to an audit request.
- On-demand reports and dashboards provide real time data, giving you the visibility and information required to make the best decisions in the shortest amount of time, increasing your effectiveness.
- Collaboration increases and access to information is improved through the use of strong search capabilities, increasing productivity and driving innovation.
- Workflows and electronic signatures ensure regulatory requirements are met and critical tasks and processes are managed efficiently, lowering costs while ensuring compliance.
- Increased efficiency in materials management through automated notification of expiration dates and aliquot management.
Through the use of Good Laboratory Practices, you can ensure consistency in both you methodologies, and your results.
The cost of doing business is lowered, knowledge is captured and becomes reusable, and the risk of non-compliance is reduced.
In the end, the quality of research, and the results of that research is improved and risks are reduced.