SAFETY & QUALITY IN THE HOSPITAL DIVISION
Supplier audits

Grifols has developed a quality system to approve, track and evaluate service providers and manufacturers of materials used during the production process. The Hospital Division’s quality system includes two main components:

Quality Assurance (QA)

This department registers relevant quality documentation for internal information systems, including GMP and ISO certifications, among others that are always kept updated.

Supplier Quality Committee

The committee holds at least one meeting every six months to verify the quality of suppliers and manufacturers.

The committee includes QA leaders, technical directors from the Barcelona and Murcia plants and senior managers from R+D+i, purchasing, production and quality assurance.

Main Relevant Regulations
  • Applicable regulations GMP environment for medicines and 13485 certification for medical devices
Safety and manufacturing controls

Grifols adheres to the highest standards of quality and safety in its manufacturing facilities to guarantee that its product and services comply with all applicable guidelines. This continuous quest for improvement allows the company to boost the quality and efficacy of its production processes and anticipate the safety needs of patients and healthcare professionals. Several committees – quality standards, suppliers, production quality, change control and R+D+i – oversee the evaluation system, placing particular emphasis on quality, KPIs and quality objectives planning.

Grifols uses a change management system to ensure the traceability and safety of any modifications in the product, process or facilities. The impact of every change is analyzed and assessed from regulatory, quality, validations, documentary, normative, occupational health and safety perspectives. A risk assessment is carried out to evaluate the impact of this change on these areas. Next, the Change Control Committee analyzes and assesses the information and when appropriate, authorizes the change and its implementation.

Main Relevant Regulations
  • Quality Management System Control: GMP, ISO Certifications 1348, MDSAP, FDA 21CFR820 and CFR 210, ANVISA, SOR 98-282, among others.
Product licenses

The production, marketing and sale of a range of products are subject to registration with the competent authorities in the countries where they are sold.

Main Relevant Regulations
  • Applicable regulations according to local jurisprudence for obtaining the product license.
2019 SUMMARY OF INDICATORS
BIOSCIENCIE DIVISION

All facilities are inspected regularly, including plasma centers. No Grifols center has had any incident related to regulatory breach, fines, notifications or voluntary codes to which the company adheres.

GRIFOLS MAINTAINS ITS COMMITMENT TO SAFETY AND QUALITY WITH OVER 300 INTERNAL CONTROLS AND AUDITS ANNUALLY
THE HIGH NUMBER OF INSPECTIONS CARRIED OUT BY HEALTH AUTHORITIES AND ACCREDITED INSTITUTIONS PER YEAR REFLECTS THE SECTOR’S STRICT SAFETY FRAMEWORK
DIAGNOSTIC DIVISION

The controls carried out reaffirm security as an unalterable commitment. Achieving the highest quality standards provides a reliable diagnosis that guarantees the proper treatment of patients.

HOSPITAL DIVISION

Quality and safety are unalterable commitments. The inspections and audits carried out guarantee top quality products to facilitate the work of health professionals and contribute to improving hospital efficiency.