GLPkrav

GLPkrav is a regulatory term used to describe the set of requirements for Good Laboratory Practice (GLP) within a specific jurisdiction or organization. It defines the standards for planning, conducting, recording, and reporting non-clinical laboratory studies that generate data submitted to regulatory authorities. The term signals a formal, legally binding framework rather than a purely voluntary guideline.

Scope and content: GLPkrav applies to both in-house and contract laboratory studies, including toxicology, pharmacology, and environmental testing. It covers study design and protocol, personnel qualifications, facility and equipment suitability, standard operating procedures, data collection and handling, study monitoring, and archiving. A dedicated quality assurance unit typically oversees compliance through systematic audits and inspections.

Compliance and enforcement: National or regional authorities establish GLPkrav requirements and authorize inspections to verify adherence. Findings of non-compliance may require corrective actions, data rejection, or penalties. Repeated violations can impact product approvals, licensing, or contracts with regulatory bodies.

Relationship to global standards: GLPkrav often aligns with OECD Principles of GLP and with local data protection and animal welfare rules. Organizations may adapt GLPkrav to accommodate regional practices while maintaining core objectives of data integrity, traceability, and reproducibility across studies.

History and usage: The term appears in regulatory literature and compliance programs in contexts where GLP implementation is being described or standardized for a particular country, industry sector, or multinational operation.

See also: Good Laboratory Practice, OECD GLP Principles, quality assurance, regulatory compliance.