Quality Management | Qualitätsmanagement

Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP) is an officially monitored quality assurance program for non-clinical testing and characterization of new compounds. The test article is in the focus, may this be a drug substance, a drug product, a herbicide/pesticide, or a food additive.

The Good Laboratory Practice (GLP) framework gives test facilities or test sites a complete insight into the regulatory requirements in order to bring your organization in line with current GLP authority expectations.

biosafety4u.berlin can help you implement a GLP quality assurance programme at your company. Regardless whether you start from scratch or you need to transform your current QA programme towards GLP.

Please download a flowchart how biosafety4u.berlin can help you implementing GLP at your organisation here.

If you have questions, please contact us at service [at] biosafety4u.berlin

Benefit from the biosafety4u.berlin GLP QA program evaluation:

• If you are a study sponsor who does only have limited capacities for GLP test facility qualification;
• If your GLP monitoring authority requires you to regularly evaluate the effectiveness of your GLP QA programm as advised in the OECD GLP No. 23 advisory document "Quality Assurance and GLP", section 12.3. "QA and assessment by third parties".

• Are you interested in a GLP competence training incl. knowledge quizzies (either on-site or remote)?
• There are SOPs that need some refreshing?
• You need an interim QA as maternity cover, or because your master schedule indicates an increasing QA workload?
• Your facility is audited or inspected very soon, and you need some assistance for getting prepared?

The GLP quality assurance program implementation and the GLP competence trainings both are conducted on the basis of the OECD Principles of Good Laboratory Practice (GLP).

There may be additional documents which transpose the OECD GLP expectations into national law. For example, the retention period for which GLP documentation should be archived is often interpreted in different ways. National GLP monitoring authorities may provide additional advisory documents helping you with implementing GLP in your facility. Please contact us if you need help in identifying the relevant documents for you.

Testimonials on GLP services - This is what clients say:

Currently in preparation. We thank you for your patience.

Good Clinical Laboratory Practice (GCLP)

Good Clinical Laboratory Practice (GCLP) describes a laboratory framework for the confidentiality and safety of participants in clinical trials in accordance with the Good Clinical Practice (GCP) regulations. Trial samples collected from trial participants are in the focus.

The Good Clinical Laboratory Practice (GCLP) framework gives clinical laboratories some guidance on clinical trial sample analysis planning, processing, and reporting.

biosafety4u.berlin conducts a GCLP facility audit and issues a GCLP Quality Audit Certificate.

Please download our GCLP audit process flowchart here.

If you have questions, please contact us at service [at] biosafety4u.berlin

biosafety4u.berlin GmbH adds a value to your current ISO quality assurance program, and brings your QA documents and internal processes in line with GCLP.

Benefit from the obvious:

• We conduct the GCLP audit for clinical trial sponsors who do only have limited capacities for laboratory vendor qualification;
• We conduct the GCLP audit for laboratories that perform the analysis of clinical trial samples, and need a competence statement from external which can be added to responses to Request for Proposal (RFP) enquiries.

Especially for large facilities who are regularly subject to trial sponsor audits it can save time and costs for all parties involved if an independent GCLP Quality Audit Certificate as a proof of competence is shared.

• Are you interested in a GCLP training (either on-site or remote)?
• There are SOPs that need some refreshing?
• Your facility is audited or inspected very soon, and you need some assistance to get prepared?

The GCLP audit and the GCLP training both are conducted on the basis of the following regulatory documents:

• ICH Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Step 4 09 November 2016.
• EMA Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples. EMA/INS/GCP/532137/2010, 28 February 2012.
• Good Clinical Laboratory Practice (GCLP), WHO 2009, ISBN 978 92 4 159785 2.
• EMA Guideline on computerised systems and electronic data in clinical trials. EMA/INS/GCP/112288/2023, 09 March 2023.
• Annex II – to guidance for the conduct of good clinical practice inspections – clinical laboratories. EMA/399244/2016, 23 August 2017.

There may be additional documents which summarize or add regulatory GCLP expectations. However, it should be noted here that these documents are considered to be non-binding as only published by non-governmental organizations.

Testimonials on GCLP services - This is what clients say:

"The competent GCLP audit process with its open-minded and hands-on atmosphere has confirmed compliance and helped us preparing for clinical trial sponsor audits. The GCLP evaluation definitively adds a valuable feature for our clients and FyoniBio." — Dr. Hans Baumeister, Managing Director FyoniBio GmbH

Services with regards to the ICH Good Clinical Practice (GCP) framework are currently being prepared. Please inquire in the meanwhile. Thank you.