The History of Good Laboratory Practices (GLP)

May, 2024 | GLP Archiving

Every time we take a pill for illness, allergies, pain, etc., we are trusting the drugs in our medicine cabinet and the standards that government agencies have set. Good Laboratory Practices (GLP) regulations play a crucial role in safeguarding this trust. But how did these regulations come to be?  

A Growing Concern for Safety 

The 1960s and 1970s saw a surge in concerns about the health impacts of chemicals used in products for plants, animals, and people as well as their impact on the environment. This led to stricter regulations in the US, particularly for the chemical and pharmaceutical industries.  

Inspections were conducted by multiple government agencies to explore misconduct tips or questionable study validity in the procedures and data of non-clinical study facilities and labs conducting animal research. 

These inspections revealed a disturbing truth – significant quality control issues plagued animal toxicology testing. Many studies lacked validity, and data reporting was riddled with deficiencies. 

The Infamous IBT Case 

The Industrial BioTest Laboratories (IBT) scandal became a turning point. This contract research and laboratory organization fabricated or delivered poor-quality safety tests for numerous chemical manufacturers and the US government.  

Thousands of non-clinical safety tests and animal toxicology studies were produced by IBT, but many of these studies included falsified information that was made up or lacked significant data to determine the validity of the study. This meant crucial data used to assess the safety of various products, from drugs to household items, could not be trusted. Hundreds of products and their efficacy was now in question. 

The Birth of GLP in the US 

The IBT case exposed the urgent need for stricter standards. Public outcry reached the halls of Congress, prompting the U.S. Food and Drug Administration to take action. In 1976, the FDA proposed the first GLP regulations in the US. These regulations aimed to: 

  • Standardize procedures and practices in non-clinical safety studies. 
  • Ensure the accuracy, reliability, and traceability of data. 
  • Guarantee the integrity of research conducted on products impacting human health and the environment. 

These regulations are known as the FDA’s Proposed Regulations on GLP in 1976 along with establishment of the Final Rule in 1979, with amendments added in 1987. The Environmental Protection Agency (EPA) followed suit, issuing its own GLP regulations in 1983. 

For more information on the government agencies and regulations covering Good Laboratory Practices, read more here. 

The Lasting Impact of GLP 

Today, GLP regulations are a cornerstone of non-clinical safety testing. They ensure the data used to evaluate the safety of chemicals and products is reliable and trustworthy. This, in turn, protects consumers and safeguards our environment. 

The history of GLP highlights the importance of adapting regulations to address evolving scientific practices. As technology advances and product development speeds up, GLP regulations will likely continue to be refined to ensure the highest standards of data integrity and safety testing. 

GLP guidelines cover the entire process on how studies are planned, conducted, recorded, and reported. Most of the spotlight is on study planning and performance, but GLP archiving is a crucial practice that covers the regulations of recording and reporting. Similar to how sponsors will use a Contract Research Organization (CRO) for drug development, archiving specialists can ensure that regulated material and data is properly stored to ensure the validity of studies for decades to come. 

 

Sources & Additional Resources: 

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