QUALITY ASSURANCE AND REGULATION
In Liof-Pharma CDMO, the strict compliance with our system of quality assurance and regulation is essential. We offer reliable and high-quality services throughout entire product life cycle. Our compliance program is based in a robust quality management system and strong compliance culture with ultimate focus on patient safety. We understand the vital importance of strictly adhering to current applicable legislations and guidelines as the unique way to obtain safe, quality, and effective products.
GMP and other certifications
We have experience and expertise in working with major regulatory authorities. Our own QA system complies with international current GMP standards, and we are regularly inspected by the relevant national and international authorities, including successfully Pre-Approval Inspection for FDA agency.
Liof-Pharma holds authorization for the manufacturing of aseptically prepared lyophilizates and small volume liquids of different type of biological products, such as:
– Immunological products.
– Gene therapy products.
– Biotechnology products: antibodies (mAB), peptides and other proteins, RNA…
Liof-Pharma also holds authorization for secondary packaging activities and quality control testing, has been EU GMP certified by the national Health Authority (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) and has been also approved by different international health authorities, amongst others:
– ANVISA (Brazilian Health Authority)
– Ministry of Health from Kuwait
– Ministry of Health from Turkey
– Health Authority from Cuba (CECMED)
We have consistently delivered this level of quality for more than 10 years.
In house Qualified Person
Liof-Pharma offers in house Qualified Person (QP) service. The QP, responsible for confirming or certifying batches of medicinal products, has the ultimate responsibility to ensure the quality of medicines and the fulfilment with the requirements set down in each product clinical trial authorisation or relevant marketing authorisation. Liof-Pharma has a QP, as well as a deputy QP, both with wide experience in pharmaceutical industry field and with an in-depth understanding of the factors that can affect the quality, safety and efficacy of medicines and supply chains.