When you’re working in a laboratory, there are several practices you should follow to ensure the safety and quality of your work. These practices are commonly referred to as Good Laboratory Practices (GLP). GLP is a vital aspect of pharmaceutical research. These principles ensure the safety, quality, and organization of research. Complying with any regulations set by government agencies, internal company procedures, and international regulations requires each member of a team to perform their duties and set quality assurance standards. This article will discuss good lab practices and highlight some of the most common examples. By following good lab practices, you can ensure the safety of yourself, your colleagues, and the quality of your work.
What is Good Laboratory Practice?
Good Laboratory Practice, or GLP, is a quality system that applies to the organizational process and conditions under which laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP covers all aspects of research that generate data for assessing the safety of chemicals and pharmaceuticals (including cosmetics).
The good laboratory practice regulations were first published in 1978 by the United States Food and Drug Administration (FDA) in the Code of Federal Regulations (CFR) Title 21, Part 58. GLP regulations in other countries have since been modeled after the FDA’s good laboratory practice regulations.
Some examples of Good Laboratory Practices include:
- Maintaining accurate and complete records
- Following standard operating procedures
- Training employees in good laboratory practices
- Conducting quality control checks
- Documenting deviations from good laboratory practice procedures
By following these good practices, you can help ensure the safety of yourself and your colleagues and the quality of your work.
GMP Vs. GLP
Good Manufacturing Practices (GMP) are a set of regulations governing pharmaceutical products’ manufacturing, processing, and packaging. These regulations ensure that pharmaceutical products are of the highest quality and safe for human use.
Good Laboratory Practices (GLP) are a set of regulations that govern the conduct of laboratory studies that generate data for the safety assessment of chemicals and pharmaceuticals.
GLP requirements are more specific than GMP requirements, and GLP-regulated laboratories are held to a higher standard than GMP-regulated facilities.
What are GLP Requirements?
The good laboratory practice regulations are found in Title 21 of the Code of Federal Regulations (CFR), Part 58. The regulations outline specific requirements for the conduct of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.
GLP studies are conducted according to a written protocol that details the study’s objectives, methods, statistical analyses, and expected results. It must be conducted by qualified personnel using appropriate facilities and equipment.
GLP studies must be conducted under the supervision of a study director responsible for ensuring that the study is conducted according to the protocol and in compliance with good laboratory practice regulations.
GLP studies are required for all nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA.
Products that are subject to GLP regulations include:
- Pharmaceuticals
- Biologics
- Medical devices
- Food additives
- Pesticides
- Chemicals
GLP studies are not required for clinical trials, which are studies conducted in humans.
The FDA enforces good laboratory practice regulations through inspections of GLP-regulated facilities. GLP-regulated facilities found to be non-compliant with good laboratory practice regulations may be subject to enforcement action by the FDA.
Good Laboratory Practice Guidelines
Listed below are Good Laboratory Practice Guidelines for different elements of a study:
Personnel
Before the study begins, the Principal Investigator (PI) must:
- Appoint a Study Director (SD)
- Determine the qualifications, training, and experience of the study personnel
- Prepare standard operating procedures (SOPs) for the conduct of the study
- Describe the duties and responsibilities of each study personnel
Study Facilities and Equipment
The study facilities and equipment must be:
- Suitable for the conduct of the study
- Maintained in good working condition
- Calibrated and tested regularly
Study Protocols
The study protocol must be:
- Approved by the PI before the initiation of the study
- Available to all study personnel
- Followed during the conduct of the study
Data Recording and Reporting
All data generated and gathered during the period of the study must be:
- Recorded in a manner that is accurate, complete, and unambiguous
- Reported in a clear and concise manner
Study Audits
An independent quality assurance unit must audit GLP studies to ensure compliance with good laboratory practice regulations. The audit must include:
- A review of the study protocol
- A review of the study data
- An assessment of the compliance of the study with good laboratory practice regulations
The FDA may audit GLP studies to assess compliance with good laboratory practice regulations.
Enforcement of Good Laboratory Practice Regulations
GLP studies found to be non-compliant with good laboratory practice regulations may be subject to enforcement action by the FDA. Enforcement action may include:
- Issuance of a warning letter
- Suspension or revocation of research or marketing permits
- Civil or criminal penalties
Implement Good Laboratory Practice with DATAMYTE
Implementing and using good lab practices requires you to create a comprehensive workflow specific to your organization and products. This process can be daunting, but with DATAMYTE and its Digital Clipboard, you can be sure that good lab practices are followed every step.
The DataMyte Digital Clipboard is a workflow automation software that ensures good lab practices are being followed by:
- Automating and standardizing data collection
- Providing real-time visibility into study progress
- Generating real-time alerts for deviations from good lab practices
- Compiling good lab practices into one convenient workflow
- Sharing and editing good lab practices workflow in real-time
- Creating checklists and other forms to help reinforce good lab practices
Schedule a demo with us today to learn more about how DATAMYTE can help you implement good lab practices.
Conclusion
Good laboratory practice must be followed to ensure the safety and quality of pharmaceutical research. Through the implementation and use of good laboratory practices, studies can be conducted in a manner that complies with good laboratory practice regulations. So, make sure good laboratory practices are being followed in your organization.
