SAFETY

GRIFOLS’ CORPORATE CULTURE PROMOTES QUALITY AND SAFETY AS CORE VALUES, WHICH ARE ARTICULATED THROUGH CONCRETE POLICIES AND RIGOROUS PROCEDURES

SAFETY, QUALITY AND MAXIMUM CONTROL THROUGHOUT THE VALUE CHAIN

As fundamental corporate values, safety and quality are fostered by Grifols’ corporate culture and integrated into every stage of the value chain. The company’s vertically integrated business model further enhances its control over production processes.

The favorable results of regular audits and inspections by health authorities, international organisms and customers over the past year are a reflection of Grifols’ adherence to these core tenets. In 2018, the company reported no cases of regulatory non-compliance, warnings or non-compliance with voluntary codes.

In alignment with its commitment to safety and quality, the company has voluntary withdrawn four lots from the market. None of the product withdrawn had a significant impact on patients.

BIOSCIENCE DIVISION

STEP 1. DONOR SELECTION

GRIFOLS ADHERES TO WORLD HEALTH ORGANIZATION (WHO), EUR PHARM, PPTA/IQPP AND CFR FDA REGULATIONS FOR PLASMA COLLECTIONS

Grifols only uses plasma from qualified donors (more information in the “Donor Profile” section) collected in centers approved by competent health authorities. Donors are subject to annual medical exams and routine health screenings before every donation.

Donors are compensated for their time and dedication. Grifols’ compensation policy ensures a sustainable supply of plasma to produce life-saving plasma-derived therapies.

Plasma donors represent a cross-section of society, from college students and homemakers to military personnel and office employees, among others.

Grifols does not discriminate against potential donors on the basis of ethnicity, gender or socioeconomic status. The company only accepts healthy donors who are committed to the donation process, have proof of a permanent local residence and meet rigorous health and safety criteria.

STEP 2. ANALYSIS OF DONATED PLASMA

TESTING LABORATORIES USE TECHNIQUES APPROVED AND VALIDATED BY THE U.S. FDA AND EU HEALTH AUTHORITIES

All units of donated plasma are analyzed in FDA-licensed laboratories to guarantee the safety and quality of source plasma. Each unit of plasma undergoes rigorous screening tests that integrate highly sensitive technologies:

  • NAT (Nucleic Amplification Testing), which detects the presence of pathogens in DNA
  • ELISA (Enzyme-Linked Immunosorbent Assay), which detects virus antibodies or recombinant proteins

More than 10 analyses are performed on each unit of plasma to test for hepatitis A, B or C, HIV and parvovirus B19, among other conditions. Once the plasma units are in production, every batch is tested at various points during the manufacturing process

STEP 3. 60-DAY INVENTORY HOLD

RAW MATERIALS FOLLOW A STRICT QUALIFICATION PROCESS, COMPLIANCE WITH GMP AND REGULAR INSPECTIONS

Grifols Supplier Qualification Management System ensures that all raw materials follow a strict qualification process. The subsidiaries that form part of the plasma supply chain adhere to good manufacturing processes (GMPs) and undergo regular inspections by health authorities.

All plasma units that pass the initial viral testing must be held for at least 60 days at a temperature equal or lower than -20 degrees Celsius before being released into production.

Known as “inventory hold,” this waiting period allows donors to return for a second donation. The results of the “hold sample” are verified against the new donation to reconfirm the absence of viruses and pathogens.

STEP 4. QUALITY GUARANTEE AND GMP

EFFICIENT QUALITY CONTROL SYSTEM IMPLEMENTED IN ALL OF ITS PRODUCTION PLANTS, WHICH UNDERGO REGULAR INSPECTIONS TO ENSURE COMPLIANCE WITH GMP REGULATIONS

Grifols carries out routine tests in its manufacturing processes and methods to guarantee the safety of its products.

Strict safety standards are enforced throughout the manufacturing process, from product development and design to the purification and formulation systems that aim to preserve the natural characteristics of the proteins. These safety standards minimize the risk of degradation of plasma proteins and improve tolerability levels for patients.

In adherence to safety standards, Grifols re-tests plasma using NAT and ELISA techniques before entering the production process.

STEP 5. ELIMINATION OF VIRUSES AND OTHER PATHOGENS

FLUID COMMUNICATIONS AND COLLABORATIONS WITH COMPANIES THAT FORM PART OF THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION MANAGEMENT BOARD, AS WELL AS THE MAIN GLOBAL HEALTH AUTHORITIES

During the production phase, approved plasma undergoes rigorous testing and purification processes, including several pathogen elimination steps, viral inactivation and viral removal techniques to guarantee the highest possible safety levels.

Depending on the product, the manufacturing process may include heat treatment, pasteurization, solvent/detergent treatment and/ or nanofiltration. Periodically, Grifols voluntarily closes its plants to perform maintenance work, expansion projects and other capital investments. The facilities have never been closed because of regulatory non-compliance while under Grifols’ control.

After purification, the product is sterilized using a proprietary sterile filling process, developed in-house by Grifols Engineering and an industry standard.

STEP 6. PRODUCT TRACKING AND FULL TRACEABILITY

THE PEDIGRI® SYSTEM ALLOWS HEALTHCARE PROFESSIONALS TO OBTAIN DETAILED INFORMATION ON THE PLASMA USED TO PRODUCE A SPECIFIC VIAL OF PRODUCT AND A CERTIFICATE OF THE TESTING PERFORMED ON IT

Before releasing any plasma-derived medicine, Grifols identifies product vials with a laser mark and holographic seal. The lasermarking system etches the lot number on each unit of product to ensure traceability. The holographic seal on product packaging verifies its authenticity as a Grifols product, as well as the safety testing performed. Through these measures, Grifols is able to monitor the safety of its products long after the production process.

As part of its collaborative efforts with regulatory authorities to prevent counterfeits, Grifols has a system that assigns unique, traceable numbers to product units in accordance with the applicable rules and regulations of the global markets where it operates. Its pledge to patient safety includes pharmacovigilance system to trace its products after their market release, in collaboration with global healthcare professionals and health authorities.

These measures enable the company to monitory the safety of its products long after they have been manufactured and distributed.

NO INCIDENTS RELATED TO LEGAL NONCOMPLIANCE, FINES, NOTIFICATIONS OR VOLUNTARILYADOPTED CODES

OUR PERFORMANCE IS TESTAMENT TO OUR COMMITMENT TO SAFETY AND TOTAL LEGAL COMPLIANCE

All production installations included in the Bioscience Division’s value chain are regularly inspected, including plasma donation centers, manufacturing plants, warehouses, testing laboratories and transport companies.

In 2018, they were subject to 287 routine internal compliance inspections and 384 inspections by health authorities.

In this regard, Grifols maintained its stellar track record, with no safety or quality deficiencies detected in the 671 inspections.

The company’s installations have never received a warning letter, license suspension or revocation for non-compliance.

The company also has an assessment system that rates suppliers on the potential risk of their product or service on the value chain. As part of this system, Grifols conducts regular audits of its suppliers and closely monitors new providers.

In 2018, 242 supplier quality audits were performed, of which 95% obtained a favorable outcome

THE GENEROSITY OF DONORS ENABLES US PRODUCE PLASMADERIVED DRUGS TO TREAT POTENTIALLY DEADLY DISEASES

GRIFOLS ONLY USES PLASMA FROM QUALIFIED DONORS TO PRODUCE ITS PLASMA-DERIVED MEDICINES

Qualified donors are those who donate at least twice over a six-month period without a positive test result.

They can donate as often as twice in a seven-day period, with a full day in between. Grifols only uses plasma from qualified donors to produce its plasma-derived medicines.

Plasma from first-time donors is never used to manufacture any of Grifols’ medicines. This plasma is destroyed or used for diagnostic or reactive use (see Bio Supplies Division), if the donor does not return for a second donation or has a positive test result.

PLASMA THERAPIES ARE ONLY POSSIBLE THANKS TO DONORS SINCE PLASMA CAN’T BE ARTIFICIALLY PRODUCED IN A LAB

REASONS TO DONATE

Because plasma donations save lives

Plasma-derived medicines are used to treat or prevent severe conditions and diseases in a number of medical fields, among them, pneumology, hematology, immunology, neurology, infectious diseases and traumatology. Plasma donors help save lives and enhance the quality of life of thousands of patients worldwide.

Because plasma can’t be manufactured synthetically

Plasma is an essential raw material of a number of hemoderivatives that are used to treat and prevent potentially life-threatening diseases and conditions. Plasma can’t be created in a lab or produced synthetically. These life-saving medicines are possible thanks to the generosity of plasma donors. 

DIAGNOSTIC DIVISION

ACHIEVING THE HIGHEST STANDARDS OF QUALITY LEADS TO RELIABLE DIAGNOSES AND HELPS ENSURE PATIENTS RECEIVE THE TREATMENT THEY NEED

SUPPLIER CONTROLS

The Diagnostic Division defines requirements regarding the assessment, approval and monitoring of suppliers, which are classified according to their importance in the production process. Results are documented in a supplier evaluation registry, and potential new suppliers are accepted or rejected depending on the results of this analysis.

To ensure quality compliance at all times, Grifols re-evaluates its quality system and standards for key suppliers every three years. This evaluation is conducted every five years for important suppliers. Low-risk suppliers do not require a new evaluation process. The division also performs a periodic analysis of quality indicators to evaluate suppliers on their compliance with specific requirements.

Grifols’ supplier audits include closely evaluating and monitoring the processes of new suppliers. The carried out 19 audits in 2018, 100% of which achieved positive results.

STRICT CONTROL AND SAFETY STANDARDS THROUGHOUT PRODUCTION

The Diagnostic Division ensures the safety, efficacy and quality of its products through a range of production, quality and R&D management processes, as well as its certification and adherence to various quality management systems such as ISO 13485, ISO 14971, MDSAP, FDA 21CFR820 and FDA 21CFR600, among others.

The division also implements project management techniques, agile software development, GMP, automation, continuous improvements and ongoing validation of its integrated IT systems. The Diagnostic Division’s talent pool receives continuous education to reinforce its technical abilities.

PRODUCT LICENSES

The production, marketing and sale of Diagnostic Division products are subject to registration with the authorities in the applicable countries.

HOSPITAL DIVISION

WE PROVIDE HIGH-QUALITY PRODUCTS DESIGNED TO OPTIMIZE HOSPITAL OPERATIONS AN FACILITATE THE WORK TO HEALTHCARE PROFESSIONALS

SUPPLIER CONTROLS

Supply chain management has a direct impact on the safety of the final product. For this reason, Grifols has developed a quality system to approve, track and evaluate service providers and manufacturers of materials that are used during the production process. The Hospital Division’s quality system is made up of two main departments:

Quality Assurance (QA)

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

Supplier Quality Committee

The committee holds at least a 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, purchasing, production and quality control.  

CONTROL AND SAFETY IN THE PRODUCTION PROCESS

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 enhance the quality and efficacy of its production processes and anticipate the safety needs of patients and healthcare professionals. Various committees – quality, policies, suppliers, production quality, change control and R&D – oversee the evaluation system, placing particular emphasis on quality, KPIs and quality objectives planning.

Grifols uses a change management system in order to ensure the traceability and security of any change in the product, process or facilities. The impact of every change is analyzed and assessed from several different point of view - regulatory, quality, validations, documentary, normative, health and safety at work. A risk assessment is carried out evaluating the different points that may be affected by the change. After that, the Change Control Committee analyzes and assesses the information and when appropriate, authorizes the change and its implementation.

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.

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