Suanfarma CDMO stands as a leading company in the production of APIs through fermentation and chemical synthesis technologies. This versatility makes Suanfarma an ideal partner to understand and meet diverse client needs.
Suanfarma CDMO service adhere to the highest quality and safety standards mandated by national and international legislation, emphasizing human safety and environmental impact as core pillars of its mission.
From development to regulatory submission, all activities are performed at Suanfarma CDMO by a multidisciplinary and highly trained team dedicated to delivering the best products and services to clients. The site also includes facilities for Microbiology, R&D, Quality Control laboratories, and warehouses for raw materials, intermediates, and finished products, ensuring proper classification, quarantine, labeling, and controlled storage conditions.
Quality & Regulatory
At Suanfarma CDMO, quality is paramount. The quality management system encompasses every stage from raw material receipt through the entire production process, ensuring the final substance meets international certification requirements and global regulatory protocols.
The Quality Unit, overseeing all production processes, analyzes critical parameters of raw materials, intermediates, and final products. This unit comprises two key areas:
- Quality Control: Responsible for analyzing raw materials, intermediates, final products, stability samples, and study samples. It is divided into laboratories for Microbiology, Physicochemical analysis, HPLC, and GC.
- Quality Assurance (QA) & Regulatory Affairs (RA): QA ensures production and control processes meet health authority criteria, managing potential quality impacts. RA acts as the liaison between Suanfarma CDMO, regulatory authorities, and clients, handling dossier submissions, revisions, and regulatory compliance.
Products must be manufactured according to current Good Manufacturing Practices (cGMP) to ensure consistent quality and safety. Cipan has undergone multiple GMP inspections, resulting in a valid GMP certificate from the Portuguese National Health Authority (INFARMED).
Continuous internal and external inspections are conducted to ensure product safety. Internal audits, managed by Quality Assurance, assess compliance with guidelines, legal requirements, customer specifications, product standards, and emergency protocols. External inspections by regulatory authorities or customers focus on GMP compliance and other agreed standards, followed by reports and corrective action plans if necessary.
