GMDP Expert-Verzeichnis

Distribution & Supply

Cold chain / temperature-controlled logistics GDP (Good Distribution Practice)

IT / CSV

Computer System Validation Data Integrity

Logistics & Distribution

Cold Chain Management GDP Compliance

Manufacturing Types

Controlled substances / narcotics Highly potent / cytotoxic Inhalation & nasal Liquid & semi-solid Oral solid dosage Packaging Sterile manufacturing Transdermal

Product Types

API Manufacturing ATMP Biologics & biosimilars Medical devices & combination products Plasma-derived medicinal products Radiopharmaceuticals Vaccines Veterinary pharmaceuticals

Quality Assurance

Annual Product Quality Review Batch Release CAPA Management Change Control Deviation Management Internal auditing Regulatory inspection support SOP Writing & Review Supplier Auditing

Quality Control

Analytical testing Biological & Immunological Testing Microbiological testing Out-of-Specification (OOS) Investigation Stability Study Design & Execution

Quality

Batch Release CAPA Management Change Control Deviation Management GMP Auditing SOP Writing & Review

Regulatory Affairs

Pharmacovigilance Pharmacovigilance QPPV Regulatory Submissions Regulatory Submissions

Validation

Cleaning Validation Cleaning validation Computer system validation Equipment qualification Facility qualification IQ/OQ/PQ Validation Method validation Process Validation Process validation

QP Humaan QP Vet GDP ISO Six Sigma ADR Prevention Environment