We Have Good Laboratory Practices (GLP) Down to a Science.

A partnership with BioAgilytix is a partnership with proven scientific excellence, rooted in a commitment to the most stringent GLP principles and processes.

As a GLP laboratory, we hold ourselves to the highest procedural standards, ensuring that our clients need not worry about compromises in the quality and integrity of results.

What Does it Mean to Be A GLP Laboratory?

As defined by The Medicines and Healthcare Products Regulatory Agency (MHRA), “Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived… this helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.” First developed in 1978 by the FDA, the principles of Good Laboratory Practice (GLP) are promoted for international use by the Organization for Economic Co-operation and Development (OECD). A Good Laboratory Practice (GLP) is inherently designed to provide a verifiable testing record to the EPA or FDA.

GLP laboratories are laboratories that adhere to GLP standards, recognizing the necessity of dependable, repeatable practices in non-clinical testing.

What are GLP Principles?

These principles span a vast gamut of topics, from guidelines on project management responsibilities and personnel, to quality assurance, facilities, equipment, platforms, standard operating procedures (SOPs), data management, and results reporting. These principles are put forth by a number of standards bodies, including the OECD, FDA, WHO and EMA, which must be adhered to for Good Laboratory Practice compliance.

How are GLP Regulations Different than GMP Regulations for Sample Analysis?

Both Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations are integrally related to laboratory testing. However, the two categories of regulation are significantly different. Their primary difference is seen in their purpose. Where GMPs are focused on demonstrating adherence to manufacturing criteria, safeguarding the integrity of scientific data, GLP refers to a quality system to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of the data.

Good Laboratory Practice Bodies

FDA
OECD
WHO
EMA

How Does BioAgilytix Adhere to GLP Procedures?

As a GMP and GLP laboratory that adheres to Good Laboratory Practice quality controls and procedures, BioAgilytix is centrally focused on preserving the consistency, dependability, reproducibility and integrity of all non-clinical safety testing practices.

At BioAgilytix, our GLP-compliant bioanalytical lifecycle services support clinical and preclinical studies for biologics, anti-drug conjugates, fusion protein, bispecific antibodies, biosimilars, and biobetters.

Our commitment to leveraging Good Laboratory Practices is about far more than regulatory compliance. Good Laboratory Practice is the cornerstone of our promise to uphold the highest levels of quality and integrity in everything we do.