Patients and healthcare professionals are at the heart of Grifols’ operations, which reflect the highest standards of quality and safety. Each division has specific policies and procedures to guarantee that quality, safety and efficiency are firmly embedded at every stage of the value chain. Grifols’ vertically integrated business model further enhances its control over its production processes.
Grifols Commercial Division’s global quality policy establishes guidelines to achieve the highest levels of quality, safety and efficiency in the sale and distribution of Grifols products worldwide. This policy ensures rigor in Grifols’ commercial and distribution operations, applying the core tenets of Grifols’ Code of Conduct, the anti-corruption policy and the established internal processes, ensuring at all times the fulfillment of Grifols’ ethical commitment.
The favorable outcomes of audits and inspections from health authorities, international organisms and customers in 2019 highlight Grifols’ staunch commitment to quality and safety. In 2019, the company didn’t have any incidents related to regulatory breach, fines, warnings or non-compliance with voluntary codes.
In 2019, Grifols was honored with the Industrial Excellence Award in Spain in recognition of its solid business model and supply chain management. For nearly 25 years, this award has recognized outstanding examples of competitiveness in the service and manufacturing sectors in diverse EU countries.
Each division has qualified suppliers whose technical, management and control capacity has been assessed and approved by Grifols quality assurance area. According to company policy, all suppliers that provide materials or services that could impact the quality of Grifols’ products must be previously qualified. Qualifications are granted for a specific material or service.
In terms of the logistics and distributions of final products, Grifols’ quality policy offers guidelines to effectively manage international suppliers and distributors, ensuring that solid measures are in place to guarantee they fulfill the established requirements.
In 2019, Grifols began developing a consolidated supplier-policy plan with global guidelines to assess their degree of risk and participation in the supply chain. In addition to ensuring their compliance with the strictest quality standards, the plan will integrate additional criteria relating to ethical, social, environmental and privacy issues.
The company is also working on a comprehensive procurement-management model, scheduled to launch in the short- to medium-term. The model will afford greater transparency and coordination in supplier relations and be global in scope, without overlooking the local needs of Grifols’ distinct business lines.
Grifols has numerous evaluation procedures in place to assess suppliers according to the level of risk of the material or service they provide and its impact on the value chain. New suppliers undergo regular audits as part of the evaluation and monitoring process. Audits of suppliers of raw materials and services focus on the quality and safety of the products and services provided. Grifols is working to add the verification of environmental certifications such as ISO 14001 (environmental management systems) and OSHA (Occupational Health and Safety Management) as part of its supplier selection and qualification process.
The manufacturing and distribution of medical and healthcare products are subject to a rigorous regulatory framework in order to promote and reinforce their quality, safety and availability. The company is committed to complying with all applicable laws and regulations and is especially transparent in its relations with healthcare professionals and organizations.
Grifols has a Pharmacovigilance System to monitor adverse reactions derived from the administration of its medicines, as well as a Surveillance System to monitor adverse reactions from the use of its medical devices.
All activities and requirements of the Pharmacovigilance System and Surveillance System for Medical Devices are outlined in Grifols’ standard operating procedures and updated on a regular basis.
Also, in addition to outside inspections by relevant healthcare authorities, both systems are subject to regular in-house audits in compliance with Grifols’ quality control systems.
Pharmacovigilance includes all activities related to the detection, assessment, understanding and prevention of adverse effects or any other complications related to the use of medicines. Each division appoints a qualified person responsible for pharmacovigilance whose main role is to establish and maintain the system and be available for healthcare authorities 24 hours a day for inspections or consultations relating to the safety of medicines and pharmacovigilance.
Medical device manufacturers are required to establish and maintain procedures to identify and monitor any adverse effects related to the use of their products. Grifols appoints qualified personnel or technical managers to maintain this system in business divisions where it applies.
Grifols does not outsource the core activities of its pharmacovigilance or medical-device surveillance systems to third parties.
The information contained in product leaflets and labels complies with the standards and regulations applicable in each country where Grifols products are distributed, including Directive 2001/83/EC for medicines marketed in Europe and Title 21 Code of Federal Regulations (CFR) in the United States, in addition to local regulations applicable in other markets.
In the case of medical devices, labels and product leaflets also include any mitigating measures identified through risk analysis activities, performed in accordance with the application of risk management to medical devices (EN ISO 14971:2012 Medical Devices) or other requirements communicated by health authorities following the review stage of the product-licensing process.
Grifols’ three main divisions have a complaints system through which all notifications received by healthcare centers, patients or users related to consumer appraisals of possible defects in product quality are recorded and evaluated.
In each division, a trained professional or technical director is appointed to evaluate all claims received; carry out the appropriate inquiries; implement corrective and preventative measures; notify healthcare authorities if necessary; and respond to the client with the conclusions obtained in the investigation of the claim.
Each division has a Product Recall System. The claims and product withdrawal systems are outlined in Grifols’ standard operating procedures and internally audited to verify their effectiveness and compliance with current legislation. They are also subject to inspections by the competent health authorities.
Grifols had no mandatory product recalls in 2019. The company’s product recall system goes beyond legal compliance and includes the voluntary withdrawal of products that fall short of its safety and quality standards. In 2019, Grifols’ pharmacovigilance systems detected a slightly higher rate of hypersensitivity reactions caused by specific vials of immunoglobulins (Gamunex®). Hypersensitivity is a possible, well-known and common reaction to immunoglobulin.
The company is committed to responsible marketing and sales practices. Thus, it ensures that all of its promotional and educational material complies with applicable laws and regulations; aligns with the industry policies and codes voluntarily adopted by the company; adequately addresses the target audience and end users; and contains information that is truthful, accurate, comprehensive, clear and balanced.
Grifols has a standard operating procedure – the Grifols Review Process or GRP – that defines the activities and responsibilities related to the approval, review and control of promotional and educational materials used to communicate Grifols’ products and services to external audiences.
The approval process for marketing materials includes several review stages and the participation of decision makers from diverse corporate areas, such as the legal, medical affairs, regulatory and communication departments. In 2019, a new improved tool for electronic review and approval of materials was implemented through the GRP system. In 2019, 4,247 materials were reviewed and 3,949 materials were approved.
The material and content are expressly approved for specific uses and countries, and can only be used without alterations. All promotional and educational materials are reviewed on a regular basis to ensure their content is valid and complies with current standards and adopted codes.