Good Manufacturing, Good Laboratory or Good Clinical Practice regulations all apply to laboratory testing, but they each serve different purposes with responsibilities being handled by different people. In the last of three articles we explore GCP.

Good Clinical Practice (GCP)
In the pharmaceutical industry, GCP is a set of international ethical and scientific quality standards for the conduct of clinical trials, designed to ensure the protection of human subjects and the integrity and reliability of trial data. Adherence to GCP is essential for the development and approval of drugs, biologics, and medical devices, and provides assurance that the rights, safety and well-being of clinical study subjects are protected in line with the Declaration of Helsinki - the cornerstone document on human research ethics to which investigators are held morally accountable.

In the 1960s trust between the public and the pharmaceutical industry was being eroded by concerns about the safety and efficacy of certain drugs and treatments. Birth defects caused by the drug thalidomide - a sedative and medication for morning sickness which had been released in over 40 countries without having been tested on pregnant women - led to the development of greater drug regulation and monitoring in many countries. 

The principles of GCP were first introduced around this time in response to the thalidomide crisis, which has been described as the "biggest man-made medical disaster ever," resulting in more than 10,000 children born with a range of severe deformities. 

Since then, guidelines have evolved alongside change in the pharmaceutical industry and advances in clinical research methodology. In 1996, the International Conference on Harmonization (ICH) developed a set of guidelines for GCP that has now become the standard for clinical trials worldwide. The principles of GCP include:

Ethical considerations: Protecting the rights and welfare of human subjects. This includes obtaining informed consent, ensuring privacy and confidentiality, and minimizing risks to participants.

Protocol design: Designing a study protocol that is scientifically valid and addresses the objectives of the trial. This includes specifying inclusion and exclusion criteria, defining study endpoints, and describing the statistical methods used to analyze data.

Study conduct: Conducting a trial in a way that is consistent with the protocol and the principles of good clinical practice. This includes ensuring that all personnel involved in the trial are appropriately trained, monitoring the safety and efficacy of the intervention, and maintaining accurate and complete records.

Data management: Ensuring the quality and reliability of trial data. This includes using validated data collection methods, verifying data accuracy and completeness, and maintaining data confidentiality.

Reporting: Accurate and complete reporting of trial results. This includes reporting adverse events and serious adverse events, describing the study design and methods, and reporting the results in a way that is clear and understandable.

A Study Sponsor has overall responsibility for initiating, financing and managing a clinical study. Functions and duties related to the study are often transferred to a Contract Research Organisation (CRO) under a team leader known as the Principal Investigator. But the ultimate responsibility for the quality and integrity of the study lies with the Study Sponsor.

Regulators such as the UK Medicines & Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require that clinical trials be conducted in accordance with GCP guidelines.

GCP standards have benefits for pharmaceutical companies that go beyond improved study quality and reduced risk to human subjects. Given their provenance, perhaps the greatest benefit that GCP confers is increased public trust in the entire pharmaceutical industry value chain. 

Hoeford is GMP-certified and can assist with pre-clinical non-GLP toxicology and batch release testing.  Contact us to find out more.

You can read our articles on GMP here, and GLP here.