cGMP Compliance & Accreditations
DANNALAB operates under current Good Manufacturing Practice (cGMP) standards with full regulatory compliance, quality assurance systems, and internationally recognized certifications.
Regulatory Compliance
cGMP Operations
Current Good Manufacturing Practice compliance for pharmaceutical testing services with quality‑assured deliverables, validated methods, and full traceability.
Pharmacopeial Standards
Testing performed in accordance with USP<941> (X‑Ray Diffraction) and Ph.Eur<2.9.33> (Characterisation of crystalline and partially crystalline solids by X‑ray powder diffraction).
Data Integrity
21 CFR Part 11 compliant electronic records and signatures. Traceable raw data with audit trails, secure storage, and controlled access.
Certifications & Accreditations
GMP Compliance Certificate (Current)*
Current Good Manufacturing Practice certification for pharmaceutical analytical testing laboratory operations.
Manufacturing & Importation Authorization (MIA)*
Manufacturing and Importation Authorization certificate for pharmaceutical testing laboratory.
European Commission JRC Validation
DANNALAB has been validated by the Joint Research Centre of the European Commission for SAXS characterization of nanoparticles.
* Available in the EudraGMDP database — search for "DANNALAB B.V. (Netherlands)".
Business Identifiers
DUNS Number: 489678876 · FEI Number: 3014153563
Registered business entity for regulatory compliance and vendor qualification.
Instrument Qualification
IQ/OQ/PQ documentation for all analytical instruments. Regular calibration and performance verification using certified reference materials.
Quality System
DANNALAB maintains a comprehensive quality system with documented operating procedures covering all aspects of laboratory operations, from sample receipt to final report issuance.
Standard Operating Procedures
Complete set of SOPs covering sample handling, method execution, data analysis, instrument maintenance, calibration, change control, and deviation management.
Method Validation & Transfer
ICH‑compliant method validation protocols. Documented method transfer packages with acceptance criteria, validation reports, and training records.
Document Control
Controlled document management system with version control, approval workflows, training documentation, and controlled distribution.
Sample Management
Chain of custody tracking, secure storage* with environmental monitoring, retention protocols, and archive management for reanalysis capability.
Quality Control & QA Review
Independent QA review of all GMP deliverables. System suitability testing, reference standards qualification, and ongoing method performance monitoring.
CAPA & Continuous Improvement
Corrective and Preventive Action system with root cause analysis. Management review, internal audits, and continuous process improvement initiatives.
*DANNALAB's unique system for sealed sample storage enables ready access for repeat evaluation, ensuring sample integrity and availability for future reanalysis.
GMP Deliverables
Certificate of Analysis (CoA)
QA‑approved Certificates of Analysis for batch release testing. Includes method parameters, acceptance criteria, results, and authorized signatures.
Validation Reports
Comprehensive validation reports documenting specificity, linearity, accuracy, precision, range, LOD/LOQ, and robustness per ICH guidelines.
Raw Data Packages
Complete raw data with 21 CFR Part 11 compliance. Diffraction patterns, audit trails, processing parameters, and instrument logs provided on request.
Regulatory Support
Confidentiality & IP Protection
Client NDAs accepted as‑is. Strict confidentiality protocols, secure data storage, and controlled access to project information.
🇪🇺 Import Testing Requirements
Importing Pharmaceuticals into the EU?
Under EU Directive 2001/83/EC, pharmaceutical products, raw materials, and intermediates imported from non-EU countries must undergo quality control testing in an EU GMP-certified laboratory before market authorization and Qualified Person (QP) certification.
DANNALAB's Netherlands-based EU GMP facility fulfills this legal requirement.