Definition and Legal Classification of GLP
Definition of GLP
GLP stands for ‘Good Laboratory Practice’. GLP is a quality assurance system that regulates the organizational processes, framework conditions, and documentation of laboratory tests. The aim of GLP is to ensure the reliability, traceability, and integrity of data generated in non-clinical tests of chemicals, pharmaceuticals, plant protection products, and other substance groups. GLP is not a scientific but a regulatory standard and, as such, has significant legal implications.
Background and Development of GLP
The first GLP principles were introduced in the 1970s by the US Food and Drug Administration (FDA) after significant manipulations and irregularities were discovered in safety studies. Subsequently, international bodies such as the Organisation for Economic Co-operation and Development (OECD) also developed legally binding frameworks for GLP to ensure global comparability and reliability of study results. Compliance with GLP is legally required worldwide and within the European Economic Area, especially for the authorization procedures of chemical and pharmaceutical products.
Legal Sources and Scope in Germany and the EU
Legal Foundations
The legal bases for GLP in Germany are comprehensive and can be found in:
- Chemicals Act (ChemG)
- Medicinal Products Act (AMG)
- Plant Protection Act (PflSchG)
- Animal Protection Act (TierSchG)
- Biological Agents Ordinance (BioStoffV)
At the European level, Directive 2004/10/EC and Regulation (EC) No. 1907/2006 (REACH Regulation) are particularly relevant. With respect to the OECD, the ‘OECD Principles of Good Laboratory Practice’ also apply.
Scope and Affected Tests
GLP regulations apply to non-clinical studies with impacts on humans and the environment. Specifically affected are tests on:
- Chemicals (REACH)
- Medicinal products
- Plant protection and biocide products
- Cosmetic substances
- Medical devices and additives
Clinical trials involving humans are not covered by GLP and are subject to other regulatory requirements such as GCP (Good Clinical Practice).
Legal Requirements and Obligations under GLP
Organizational Structures
According to GLP, a test facility must have clearly defined organizational structures. The requirements include the appointment of a study director, a quality assurance unit, and a test facility management. The areas of responsibility and accountability must be detailed in written SOPs (Standard Operating Procedures).
Conduct and Documentation of Tests
GLP requires comprehensive and traceable documentation of all experiments, methods, data, and results. This includes recording equipment maintenance, calibrations, raw data, study plans, deviations, and final reports. The data must be retained in the long term, usually for at least ten years.
Quality Assurance System
An independent quality assurance unit must be established to regularly check whether GLP requirements are being met. This unit documents and reports violations and corrective actions to the test facility management and, where appropriate, to the competent authorities.
Legal Consequences and Significance of GLP Compliance
Obligation to Maintain GLP Compliance
If research results are submitted as part of statutory approval procedures (e.g. chemicals approval), compliance with GLP is legally required. Authorities may require proof of GLP compliance. Tests not conducted under GLP may not generally be used for evaluation and could result in rejection of the approval application.
Supervision and Control
GLP is subject to government supervision. In Germany, the competent state authorities or the Federal Institute for Risk Assessment (BfR) are responsible for inspections and audits. Regular inspections and study audits are carried out to monitor GLP compliance. Violations can lead to administrative sanctions, including revocation of certificates, fines, and criminal investigations.
International Recognition
Test reports prepared under GLP conditions in OECD member states are mutually recognized. This is legally anchored in the OECD Mutual Recognition Agreement. Mutual recognition facilitates the international approval of products and minimizes duplicate studies.
Special Provisions and Exemptions
Sector-Specific Provisions
For various substance groups, such as biocides, medicinal products, or plant protection products, there are additional legal provisions that may impose stricter or different GLP requirements. For special test parameters, further guidelines and technical standards may also be mandatory.
Exemptions and Deviations
In justified exceptional cases, supervisory authorities may permit deviations from GLP. However, this requires a stringent justification and a documented risk assessment. The decision on exemptions always lies with the respective state or federal authority.
Sanctions and Legal Remedies
Sanctions for Violations
Violations of GLP requirements may result in administrative, regulatory, and civil law consequences. Typical sanctions include:
- Withdrawal or rejection of official approval notices
- Fines and administrative penalties under the Chemicals Act and other regulations
- Criminal investigations in the event of data manipulation and intentional violations
Legal Remedies
Affected parties have rights of objection and appeal to the administrative courts against official measures related to GLP (for example, revocation of GLP recognition or prohibition of use of test data).
Conclusion: Legal Significance of GLP
GLP is a central element of regulatory quality assurance in the chemical, pharmaceutical and environmental sectors. It ensures lawful conduct and documentation of laboratory studies. The comprehensive legal regulation and control at both national and international levels make GLP an indispensable pillar for the approval of safety-relevant products and offer a reliable framework for consumer protection as well as for environmental and health safety. Strict compliance with GLP is of fundamental legal relevance for every test facility, laboratory, and applicant in statutory approval procedures.
Frequently Asked Questions
Which statutory provisions regulate the conduct of GLP in Germany?
The conduct of Good Laboratory Practice (GLP) in Germany is essentially regulated by the Chemicals Act (ChemG), specifically §§ 19a-19c ChemG, and the associated Chemicals-Gene Technology Assurance Ordinance (ChemBiozidDV). Also relevant are the GLP Ordinance (Chemikalien-Verbotsverordnung – ChemVerbotsV) and the application guidelines provided by the Federal Institute for Risk Assessment (BfR) and the competent state authorities. At the European level, Directive 2004/10/EC is decisive; it requires the application of GLP principles to certain test procedures and calls for the mutual recognition of test data between member states. Internationally, the OECD Principles of Good Laboratory Practice are binding, as Germany participates in the OECD’s ‘Mutual Acceptance of Data’ system. Companies must ensure that all GLP-relevant activities conform to this legal framework in order to achieve legal recognition and international acceptance of test results.
Who monitors compliance with GLP requirements in Germany, and what legal powers do these authorities have?
In Germany, compliance with GLP requirements is mainly supervised by the competent monitoring authorities of the federal states. These act as GLP inspectorates under §§ 19b and 19c ChemG. The authorities have extensive powers of inspection and intervention: They are entitled, in particular, to enter operating sites (with or without prior notice), inspect test records and other relevant documents, make copies of documents, and take samples. As part of GLP inspections, compliance with legal and normative requirements is checked, deficiencies are documented, and measures may be imposed. In the case of violations, the authorities may order corrective actions, revoke approvals, or, if necessary, initiate administrative offense or criminal proceedings.
What are the legal consequences in the event of a GLP violation?
If GLP violations are identified, various legal consequences are possible. Firstly, the recognition of studies or their results may be denied, which can lead to significant economic damage, especially in approval procedures. In addition, sanctions may be imposed under §§ 26, 27 ChemG: Fines may be imposed and, in the case of repeat offenses, criminal proceedings may also be initiated. Results generated from tests not compliant with GLP cannot be used in approval procedures under REACH, the Plant Protection Products Regulation, or the Medicinal Products Act. Finally, a violation may also have civil law implications, for example, if third parties suffer harm due to incorrect test reports and claim damages.
What rights and obligations do sponsors have from a legal perspective in the context of a GLP study?
Sponsors – often the clients of the studies – share legal responsibility for ensuring that GLP studies are conducted in compliance with the law. Their duties include the careful selection of a qualified, GLP-recognized testing institute and the provision of all information relevant to study planning and evaluation of results. Legally, they must also ensure that all study documentation and raw data are archived in accordance with statutory retention periods. Sponsors are entitled to receive complete and truthful reports from the testing institute and may exercise rights to information and inspection, especially during audits and official inspections. However, they are also obliged to notify the authorities, for example, if non-compliance is identified.
What are the legal requirements for the archiving and retention of GLP-relevant documents?
According to GLP regulations, all relevant testing documents, including raw data, study plans, final reports, and, if applicable, samples, must be retained for a minimum period of usually 10 years (depending on the specific legal area, possibly longer). Responsibility for proper archiving generally rests with the study director, organizationally implemented by the designated archivist of the company’s GLP system. Archiving must ensure completeness, integrity, and legibility throughout the retention period. Failure to comply with retention obligations can jeopardize the legal recognition of study results and may result in supervisory measures up to and including revocation of GLP status. Electronic archiving is permitted provided the legal requirements for data security, integrity, and immutability are met, which must be ensured through appropriate validation and audit trails.
Does a test facility in Germany have to be certified according to GLP, and what are the legal consequences of lacking recognition?
A formal ‘certification’ in the form of a certificate does not exist for GLP; rather, recognition is granted by the authorities following a successful inspection in accordance with the ChemG. Test facilities wishing to conduct studies within legally regulated procedures (e.g., chemicals law, plant protection law, medicinal products act) must have this official GLP recognition. Without recognition, data collected may not be used in the respective approval procedures, which amounts to a de facto professional ban for GLP-mandated activities. Moreover, unauthorized activities may result in regulatory or even criminal consequences. Clients and sponsors may also be liable if they commission studies to facilities not duly recognized under GLP.
What is the significance of GLP compliance in the context of international and European approval procedures from a legal point of view?
GLP compliance is a mandatory requirement for the international and European mutual recognition of test reports in approval procedures for chemicals, medicinal products, biocides, or plant protection products. The legal basis derives from EU law (in particular Directive 2004/10/EC and Regulation (EC) No. 1907/2006 [REACH]), national law, and bilateral or multilateral OECD agreements (MAD: Mutual Acceptance of Data). If GLP compliance is lacking, authorities in the EU and many other countries will not acknowledge the test data. This means a product cannot obtain the required authorizations, resulting in significant legal and economic disadvantages for applicants. Ensuring and fully documenting GLP compliance is therefore a central element of an effective authorization process.
