Good Laboratory Practice (GLP) audit
Good Laboratory Practice (GLP) ensures the integrity of non-clinical laboratory studies by regulating organisational processes and conditions. It guarantees adherence to quality standards, accurate reporting, safe archival of data, and proper laboratory management. By passing GLP audit, laboratories demonstrate that they fulfill the stringent requirements in quality and integrity.
Scope of Good Laboratory Practice
GLP is applicable to any non-clinical laboratories that run testing, among the others, on
- Pharmacy and drugs
- Cosmetics
- Food additives
- Medical Devices
- Biocides and Detergents
In the U.S., these laboratories are required by FDA to be compliant with 21 CFR Part 58 Good Laboratory Practice to ensure safety and quality to end consumers. In the EU, similarly, laboratories are expected to fulfill Directive 2004/9/EC and Directive 2004/10/EC. Globally, OECD Principles of Good Laboratory Practice (GLP) is applied.
Requirements of Good Laboratory Practice
Good Laboratory Practice focuses on the risk-based quality assurance programme in place at the laboratory. GLP comes in a set of guidelines and principles that ensure the quality and integrity of laboratory research. It covers various aspects of laboratory operations, including study design, record-keeping, equipment calibration, personnel training, and quality control. The primary goal of GLP is to ensure that laboratory research is conducted in a consistent, reliable, and reproducible manner, which helps to minimize errors and improve the accuracy of results.
Good Laboratory Practice audit by Eurofins
To demonstrate compliance, the most effective way is to employ accredited third-party services providers like Eurofins to conduct your GLP audit. With a global network of highly experienced GLP auditors and robust knowledge about the standard, we can support your GLP audit needs promptly.
The on-site GLP audit will take one working day, but duration varies depending on the sizes of the facilities and complexity of tests involved. Eurofins’ professional GLP auditors will run document review, conduct interviews with laboratory personnel, and observe laboratory procedures to assess if these practices observe GLP requirements. When the audit is completed, an audit report with detailed findings will be sent to the facilities, and facilities are expected to close any CAPAs.
Why choose Eurofins for your GLP audit?
We possess over 25 years of experience in the pharmaceutical and healthcare industry, supporting customers around the world on their compliance journeys. Our global network of auditors allows us to respond to your requests swiftly with travel costs and time minimised. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver.
In addition to on-site audit services, thanks to our expertise, we can deliver training and advisory services to better support customers who need extra help in reaching compliance goals. Shared GxP audits and purchase of GxP audit reports are both available online to offer fast and streamlined experience.
When working with us, our professional and customer-centric teams assist you along your GMV audit, and provide your GMP audit reports on time.
Auditing activities are compliant with international regulations such as EU, US, Brazilian, Canadian and more.
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