Quality Assurance
At Liof Pharma, strict adherence to our quality assurance system is essential.
We provide reliable, high-quality services throughout the entire product lifecycle. Our policy is based on a robust quality management system and a culture of compliance, with a strong focus on patient safety. We rigorously comply with current legislation and guidelines to ensure safe, effective, and high-quality products.
GMP and Other Certifications
Experience and Standards
Compliance with international GMP standards.
Regular inspections by national and international authorities, including the FDA.
Manufaturing Authorizations
Aseptic lyophilized and small-volume liquid manufacturing.
Product types:
- Inmunological products.
- Gene therapy: adeno-associated viruses (AAV) and AAV vectors.
- Biotechnological products: oligonucleotides, monoclonal antibodies (mAbs), peptides, and other proteins.
Certifications and Recognitions
GMP certification granted by AEMPS (Spain).
Approvals from:
- ANVISA (Brazil)
- Ministry of Health of Kuwait
- Ministry of Health of Turkey
- Health Authority of Cuba (CECMED)
Over 15 years of strict quality and regulatory compliance.
Qualified Person (QP/DT) Service
Liof Pharma has a Qualified Person (QP) and a backup, both with extensive experience in the pharmaceutical industry.
Responsabilities:
- Confirming and certifying pharmaceutical products batches.
- Ensure quality and compliance with requirements established for each clinical trial or commercial authorization.
- Continuous monitoring of factors that may affect the quality, safety and efficacy of medicinal products and supply chains.