Is there something wrong with Good Clinical Laboratory Practice (GCLP)?

Why is there no distinct United States (US) Food and Drug Administration (FDA) regulation for GCLP? Many who work in the pharmaceutical industry know that if you search the term “GCLP,” the results show laboratories that focus on the analysis of non-human samples according to Good Laboratory Practice (GLP) practice standards.  But wait a minute, this is a bit confusing.  Let’s start by reviewing the definition of GCLP, who produced it, and what it means to us.

The problem with GCLP

Back in the early 1980s when animal testing laboratories modified their quality systems to incorporate GLP, there was a lot of resistance from the scientific community.  Many scientific purists believed that GLP regulation would lead to the end of pure and applied science.  Others said that regulation would mean the end to drug research because of the extra documentation and archiving requirements.  Of course, we learned that none of those concerns became true.  In fact, the requirements forced the scientific community to honestly record research results that others could replicate.  Unfortunately, FDA never got around to promulgate regulations for laboratories who analyze specimens taken from human subjects enrolled in clinical studies.

By the end of the 1990s, many pre-clinical GLP laboratories became very efficient and very good at animal specimen analysis.  At that time, the GLP regulations were almost 20 years old and the days of regulatory surprises were mostly over.  Laboratory staff and management were both very comfortable with the GLP regulations and the growing use of computers became a driving force in laboratory analysis.  Laboratory information management systems were becoming more sophisticated, along with bar code labeling and tracking of specimens.  So, what could an ambitious team do at a laboratory that wanted to grow?

In the early 2000s, GCP human analysis work was rapidly expanding.  A whole lot of new Phase 1-4 human research studies were out there and needed analytical testing to support their marketing applications.  The number of laboratories focusing on GCP human specimen analysis were not meeting market demand.  The answer to getting more work for a GLP laboratory to process was simply to make a bigger pie.  By the end of the last decade, many GLP laboratories expanded their services to include GCLP analysis.  And why not?  The systems and equipment were in place for high quality analysis work at most GLP laboratories.  Many GLP laboratories only had to make some relatively minor changes, modification, and upgrades to meet GCLP requirements.

(WHO) it is

The World Health Organization (WHO) and British Medicines and Healthcare Products Regulatory Agency issued the Good Laboratory Guideline in 2009.  After the guideline was published, it became a very popular, referenced international standard for GCLP.  GCLP is defined as the principles established under GLP for data generation used in regulatory submissions relevant to the analysis of samples from a clinical trial (i.e. specimens taken from a human being).  At the same time, it ensures that the relevant objectives of the GCP principles are carried out for reliability and integrity of generated data.

One regulation size doesn’t fit all

We know that GCP alone does not define laboratory analysis requirements and GLP focuses on animal testing.  The combination of GCP and GLP principles into GCLP offers guidance to ensure high quality and the reliability of human clinical trial analysis data.  The regulators really like this – which is a huge, positive factor to those who work in the pharmaceutical industry.  Regulators who are satisfied with GCLP compliance often result in a higher probability of drug approval.  A high drug approval rate means more sick people become healthier, drug researchers get bragging rights, pharmaceutical organizations become stronger, and stockholders become wealthier – everybody wins.

Bridging the GLP and GCP gap

Using the WHO GCLP guideline, GLP laboratories who wanted to meet GCP requirements, performed a gap analysis to determine what was needed to meet GCLP requirements.  GCLP provides a bridge between GCP and GLP requirements.  GCLP helps ensure the reliability and quality of clinical trial data generated by laboratories.  GCLP focuses on laboratory factors including archiving, confidentiality, equipment, facilities, materials, organization, procedures, quality assurance, quality control, reagents, records, reports, specimen handling, storage, sub-contracting, and training.

Click below for an infographic that highlights 15 core components of GCP and GLP with an amalgamation as seen in GCLP.

Click here to download our 15 Core Components of GCLP guide

 

So, why do you think the US FDA has not recognized GCLP? Let us know below…