GLP Facility Certification Program

Good Laboratory Practices (GLP) are standards to ensure laboratory studies are consistent, reliable, and ethical. GLP covers essentially every aspect of laboratory operations, such as:

• Study planning
• Execution
• Recording
• Reporting

Adhering to these standards maintains data quality and integrity, which is critical for regulatory submissions and approvals. GLP compliance enhances the credibility of research findings, is crucial for regulatory compliance, and ensures the safety of non-clinical studies.

GLP training prepares graduates to abide by these standards throughout their day-to-day tasks. A reputable training institution will impart the knowledge and skills necessary to meet GLP standards throughout laboratory studies, avoiding non-compliance and paving the way for submitting documents to regulatory agencies.

Taking a GLP training course is advised for professionals involved in non-clinical laboratory studies across a wide range of roles, such as:

• Lab technicians
• Quality assurance staff
• Researchers
• Project managers
• Management
• And more

Essentially, every role in a laboratory setting requires a strong understanding of GLP standards and how to apply them to current or future job responsibilities. Additionally, continuous education is crucial for maintaining compliance and keeping personnel updated with the latest edition of GLP standards.

GLP training covers various topics related to working in laboratory settings. The exact curriculum will depend on the training institution and specific course. Additionally, GLP training online may vary from in-person training.

However, we can still explore the general topics you can expect from a GLP training course to help you better understand the course material.

Organizational Structure and Personnel

Ensuring accountability and the implementation of GLP standards requires clearly defined roles and responsibilities. Personnel should have the applicable training so they can carry out their specific tasks in full compliance with GLP protocols.

Every role throughout a laboratory setting has unique responsibilities pertaining to GLP, so training programs should be relevant to the individual attendee. 

Quality Assurance Program

GLP places a heavy emphasis on quality assurance programs, requiring dedicated QA teams prepared to monitor processes for adherence and compliance. Conducting regular audits, inspections, and creating comprehensive reports are necessary to identify and correct any areas that may be lacking.

The QA teams should also be involved in monitoring active studies and potentially be involved in the planning process to make sure every step is fully compliant.

Documentation

GLP standards involve strict documentation for routine procedures that stakeholders must approve. Deviating from these standards may be necessary, but it will require the explicit approval of a decision-maker and the necessary documentation.

Most or all of this documentation may be necessary to earn regulatory approval. Following GLP best practices for creating and updating documentation is critical to earning final approval.

Labeling and Storage

The methods used to label and store materials or substances are vital, both for maintaining compliance and preventing cross-contamination that may affect the study's results. Ensuring the overall integrity of substances used in a study is the responsibility of several different roles, making comprehensive training necessary.

CfPIE is an industry leader in life sciences training. Our years of experience providing detailed training programs across topics like GMP and GLP compliance have led to the development of effective training programs. 

Our GLP training course, online or in-person, prepares graduates to maintain compliance throughout their daily responsibilities. A few of the advantages of our GLP training programs are:

• Comprehensive curriculum: Our curriculum covers all critical aspects of GLP standards. We provide instructions for regulatory requirements, compliant standard operating procedures, documentation practices, and developing QA programs.
• Expert instruction: Our courses are led by expert instructors in laboratory compliance. Our seasoned instructors have an extensive understanding of GLP, including real-world experience. They’ve experienced maintaining GLP compliance firsthand and are ready to give students a strong understanding of the practical application of these standards.
• Flexibility and customization: We know every attendee has unique needs and existing schedules, so we offer classes capable of meeting a wide range of needs. We provide on-site and remote training that can be tailored to your organization’s specific needs, which can vary based on the specific research focus. You’ll have confidence that graduates will be ready to apply this understanding directly to their current roles.
• Certification and career advancement: After completing the final test, graduates will receive a certificate indicating their understanding of GLP standards and compliance requirements. This certification demonstrates a commitment to quality and overall compliance in laboratory settings so they’re ready to add value to their current or future employer’s operations.

Each of these advantages makes CfPIE the right choice for GLP training that imparts the right balance of knowledge and hands-on skills to help graduates succeed.

Failing to comply with GLP regulations can have many consequences, including fines, suspensions, and possibly even bans on future research. Regulatory agencies, such as the FDA or EU’s EMA, may issue warning letters at first and then proceed to harsher penalties if companies don’t implement corrective actions.

Another possible outcome is data invalidation. Regulatory bodies may reject research data if it is deemed unreliable due to not following GLP standards. If data from a study is invalidated, the study will need to be repeated, causing delays and increasing costs.

Beyond the direct actions taken by regulators, your organization may lose credibility and overall reputation harm. Trust is a critical component of scientific fields, and lost credibility is hard to recover. Future research opportunities and partnerships may suffer as a result.

Adhering to GLP standards is mission-critical for regulatory compliance, maintaining data integrity, and building research credibility. GLP training courses help organizations keep personnel up to date on the latest changes so every step in the process is compliant.