Good Laboratory Practice (GLP) Audits

GLP refers to Good Laboratory Practice. This is a quality system assuring the reliability, integrity, and reproducibility of nonclinical laboratory studies, particularly for studies which include safety testing of pharmaceuticals, chemicals, cosmetics, pesticides, and medical devices. GLP ensures that the data generated from studies that are submitted to the regulatory authorities is credible and is trustworthy.

GLP applies to nonclinical laboratory studies conducted for regulatory purposes. This generally includes toxicology studies and studies that may include such things as safety pharmacology, genotoxicity, biocompatibility studies, and studies in environmental safety, or any other experiment or study that is intended to support approvals for products for human use, veterinary use, or environmental use.

• Find risks earlier, both saving time and money.

• Build confidence in you with regulators, partners, and consumers.

• Show that you are dedicated to product safety and product quality.

GLP is legally mandatory for nonclinical safety studies that are submitted for regulatory purposes, including FDA, OECD, MHRA, EMA, or other national regulatory agencies that have regulations supporting GLP. If a study has not been conducted in accordance with GLP, the study will usually be rejected or the study will need to be repeated. Either way, this would incur costs and additional time for product approvals.

Compliance with GLP is regulated by governmental agencies including, but not limited to, the FDA (in the USA), MHRA (the UK), the various member authorities of the OECD, the EMA (Europe), and a variety of national GLP monitoring units. These agencies frequently inspect laboratories and issue compliance letters or citations.

GLP applies to non-clinical laboratory studies and addresses the integrity of the study, data reliability, and documentation.

 GMP applies to the manufacturing of products and addresses consistency, quality, and safety of the products.

 Simply stated:

• GLP = Laboratory studies
  
  
• GMP = Manufacturing processes

Key GLP principles include:

• Clearly defined study plans and protocols
  
  
• Qualified study directors and personnel
  
  
• Proper documentation and data integrity
  
  
• Validated instruments and calibrated equipment
  
  
• Controlled environments (temperature, humidity, storage)
  
  
• Retention of raw data, samples, and reports
  
  

Quality Assurance (QA) oversight
These principles ensure the study’s traceability and scientific reliability.

Complete and accurate documentation is required in GLP so every part of the study can ultimately be replicated. Regulators publish the rule of thumb as: “if it isn’t documented, it didn’t happen.” 

 This ensures that the study is traceable, is ready for an audit, and demonstrates that the study has scientific integrity.

The QA unit must be independent from the study team. QA is, responsible for:

• – Auditing protocols, raw data, and final reports
• – Inspecting how the study is conducted
• – Verifying compliance with GLP regulations
• – Alerting management if there are any deficiencies
• This independence ensures the integrity of the study data.

Non-compliance may lead to:

•  Findings during a regulatory audit
•  The data being rejected or having to repeat studies
•  GLP certification or approval being suspended
•  Loss of trust from customers
• Legal penalties in extreme cases
• Failure to comply with GLP can have a major impact on time and cost during product development.

Regulatory authorities will issue a compliance statement for GLPs and not a certificate (like ISO). To be compliant, GLP systems must be put in place, staff must be trained, methods must be validated, documentation must be maintained, and a successful regulatory GLP inspection must occur.