The Spanish Agency for Medicines and Medical Devices certifies compliance with Good Manufacturing Practices at the Lugo-based laboratory specialising in advanced analytical services
AMSbiopharma, an advanced analytical CRO (Contract Research Organization) specialising in services for the pharmaceutical, biopharmaceutical and chemical industries, is a physicochemical and biological quality control laboratory authorised by the Spanish Agency for Medicines and Medical Devices (AEMPS) for human medicinal products, veterinary medicinal products and investigational medicinal products for human use. The company has now obtained certification of compliance with Good Manufacturing Practices (GMP) after successfully passing the audit conducted by AEMPS. These standards, internationally known as GMP (Good Manufacturing Practices), constitute one of the main frameworks for ensuring the quality of medicinal products. With this recognition, the Lugo-based company, part of the AMSlab Group, becomes the first analytical services laboratory in Galicia with GMP certification for medicinal product quality control, a milestone that strengthens its position as a strategic partner for the pharmaceutical and biopharmaceutical industries.
The GMP certification confirms that the analytical activities carried out by AMSbiopharma comply with the high quality standards required by the pharmaceutical industry, ensuring the reliability of results, data integrity, process traceability and compliance with applicable regulatory requirements.
Good Manufacturing Practices constitute one of the main international frameworks for ensuring the quality of medicinal products. In the field of analytical laboratories, this certification confirms that facilities, equipment, procedures and quality systems operate under strict controls that ensure the consistency and reliability of the services provided.
Behind these controls lies a fundamental objective: to help ensure that the medicinal products reaching patients meet the required quality and safety standards. Analyses performed in specialised laboratories such as AMSbiopharma are part of the processes used to verify the quality of medicinal products and their components throughout their development and manufacturing.
Obtaining this certification marks the culmination of a transformation process that began three years ago, during which AMSbiopharma has carried out a major upgrade of its facilities, equipment, procedures and quality management systems to meet the demanding regulatory requirements of the pharmaceutical sector.
“Becoming the first analytical services laboratory in Galicia with GMP certification for medicinal product quality control represents recognition of the work carried out over recent years and a boost to continue growing,” says Manuel Lolo, CEO of the AMSlab Group. “This certification reflects our commitment to scientific excellence, quality and continuous improvement. It also enables us to strengthen our analytical capabilities and offer our pharmaceutical and biopharmaceutical clients an even higher level of confidence, safety and regulatory assurance in every project.”
AMSbiopharma provides advanced analytical services to support the pharmaceutical, biopharmaceutical and chemical industries throughout all stages of medicinal product development, from research and development to quality control.
With this recognition granted by AEMPS, this Lugo-based laboratory takes another step forward in its growth and specialisation strategy, positioning itself at the forefront of regulated analytical services and strengthening the role of Galicia within Spain’s pharmaceutical and biotechnology ecosystem.