Updated on October 18, 2023
Introduction to Clinical Trial Regulations
The quality of data and goods must be of the highest standard in clinical research, which renders the need for Good Laboratory Practice (GLP) regulations, Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) regulations. In the world of clinical research, there is always a need for clarity between similar terms such as GLP, GCP, and GMP. This is quite understandable as they are all related to quality data collection and laboratory testing and sound similar. Along with this, scientists and quality assurance personnel play different roles in all three of these, which we will discover in a short while.
Revival Research Institute is a leading clinical research organization based in Texas, Michigan and further expanding in new locations. Our numerous sites spanning across the States follow strict ethical practices and ensure that the data produced is of the highest quality. This blog will dive deep into each of these practices — GLP, GCP, and GMP, with a particular focus on GLP clinical trials.
What are GCP, GMP, and GLP Clinical Trials?
The International Conference on Harmonization (ICH) provides the Good Clinical Practice (GCP) guidelines. The ICH GCP keeps the ethical and scientific quality of clinical trials in check. It includes clinical trial study design, research technique, and all data reporting.
Good Manufacturing Practice (GMP) regulates the design, control, and monitoring of drug manufacturing processes and their facilities. GMP compliance regulates the identity, strength, quality, and purity of drug products.
Good Laboratory Practice (GLP) regulates the processes through which clinical and non-clinical research is carried out. GLP clinical trials also govern how these research facilities should be maintained and the conditions under which they are carried out.
Good Clinical Practice Regulations
Good Clinical Practice, however, is geared more towards the safety of participants in the trial. According to GCP principles, a safe and efficient mechanism is to be placed to report all adverse events (AE) or severe adverse events (SAE). GCP also oversees the data collection during clinical trial phases. The data collection from the trial should comply with GCP regulations to ensure high data quality. Under ICH GCP, the sponsor should ensure that all the required SOPs are clearly laid down and adhered to. The monitoring process must be well documented so that the study meets standards throughout the clinical trial, also setting the level of the GCP monitoring process. The FDA maintains a bioresearch monitoring program (BIMO) that inspects clinical and non-clinical studies related to FDA research and marketing submissions.
Good Manufacturing Practice Regulations
As the name suggests, GMP regulations focus on the quality of manufactured goods. Good Manufacturing Practices are quite flexible which is why they give manufacturers control over what alterations they can make but all GMP protocols rely on heavily tested scientific principles. It also needs strict quality management measures, usage of high-quality raw materials, identifying deviations in products, and use of reliable testing labs. Putting GMPs into place ensures quality standard adherence if the final product is properly used.
The FDA inspects pharmaceutical and pharmacovigilance companies throughout the world to see if they are GMP-compliant. If a company produces a defective drug by not abiding by the rules, a recall could be issued. Although the FDA cannot force a company to recall defective drugs, it can effectively warn the public of any dangers associated with the drugs and seize them if they are present in the marketplace. To resolve GMP violations, the FDA may potentially seek a court injunction.
Good Laboratory Practice Regulations
GLP clinical trials are done to ensure trustworthiness in the laboratory database and overall lab practices. Clinical trials are GLP-compliant, if they have established:
- assigned study directors
- a quality assurance unit (QAU)
- standard operating procedures (SOPs) that researchers adhere to
- a written study protocol
- a final study report
The FDA possesses the authority to examine the research that serves as the foundation for goods sold in the United States, regardless of their origin or production location. The FDA is required to perform routine inspections to assess GLP compliance at least once every two years. Additionally, they have the option to carry out inspections in response to specific concerns if there is evidence suggesting that a research site is not adhering to GLP clinical trials regulations.
Ethical Consideration in Clinical Trials
Ethical considerations in clinical research hold profound importance. They form the ethical backbone of any responsible and scientifically rigorous research endeavor. These considerations are crucial for safeguarding the safety and well-being of research participants, ensuring their autonomy and dignity are respected, and minimizing potential harm. Additionally, ethical standards nurture trust among participants and the public, which is essential for research participation and support.
Key ethical considerations include informed consent, beneficence, non-maleficence, fair participant selection and transparency among others. These considerations also contribute to the scientific validity of research by upholding meticulous and transparent methodologies. Moreover, ethical guidelines enable international collaboration, allowing researchers from diverse backgrounds to work together while adhering to common ethical principles. Ultimately, ethical research practices not only advance scientific knowledge but also have a profound impact on individual lives, healthcare, and society as a whole.
Talking about ethical considerations in clinical research, it is important to note that there is a list of ethical concerns when it comes to clinical trials that need due attention. To avoid such issues, it is essential to have a skilled team of professionals in your team that is well-equipped on GCP, GMP, and GLP to ensure clinical trials are conducted within ethical guidelines.
A Word from Revival Research Institute
Revival Research Institute was established to help people gain access to novel therapeutics that are not available in the market. We are an outpatient clinical research organization dedicated to providing people with high-quality treatment and data to sponsors. The very reason for our being is to collaborate with a strong team of skilled Investigators and seasoned research personnel to work and establish exciting, empowered communities through clinical trials. Revival gives people throughout the United States access to safe, innovative, and free treatments and therapies.
Compliance to GCP, GMP, and GLP clinical trials all exist to ensure a smooth process that is held to the highest of scientific and ethical standards. GLP clinical trial regulations are usually concerned with good study protocols and proper record-keeping. These help in protecting the integrity of the findings. GCP, on the other hand, is more geared toward the safety of clinical trial participants and remains of utmost importance. The GCP guidelines are set by the ICH. Finally, GMP requirements ensure that the manufacturing process is of high quality, with enough quality control and assurance mechanisms in place.
All three sets of rules and regulations safeguard patients, participants in research, and researchers. This means ensuring and strictly enforcing these rules can improve the overall healthcare outcome for communities.