Further integrate environmental, social and governance principles into our value chain to reinforce a differential patient- and donor-oriented business model that promotes quality, sustainability, transparency, respect for human rights, non-discrimination and equal opportunities.

Our roadmap. Grifols 2030 Agenda

  • Evaluate suppliers using ESG criteria
  • Maintain claims ratio in Biopharma: ≤ 1 per 50,000 units distributed
  • Achieve zero critical issues in external audits


  • Vertically integrated, from donor to patient
  • Global and diverse
  • Major strides in process optimization
  • Continuous improvement

Our priorities

  • Ethics
  • Transparency
    Human rights
  • Safety and
  • Sustainability
  • Legal compliance

In pursuit of excellence

Grifols has a range of policies and procedures to advance its sustainable and responsible value chain, with quality and safety standards that far surpass regulatory compliance. In its ongoing quest for excellence, the company follows due-diligence procedures to prevent or mitigate all detected or potential adverse effects on human rights or the environment.

Safety and quality are top priorities

As a leader in global health care, Grifols does its utmost to guarantee the highest levels of quality and safety of its products and services. This core commitment is driven by senior management, ratified in the Code of Ethics and extensive to the entire organization. The Chief Quality Officer (CQO) makes sure that all safety and quality control processes are effectively managed and implemented.

Grifols’ Corporate Quality Policy reflects its commitment to conduct all operations in adherence with the highest standards of quality and safety, and advance its mission of improving people’s health. In this way, Grifols creates sustainable long-term value for patients, donors, the healthcare community, collaborators and society as a whole.

Grifols’ business units have robust policies and procedures to assure the highest quality, safety and efficacy throughout the value chain. Encompassing all corporate functions, the quality-assurance system delivers continuous employee training and development initiatives to continually advance Grifols’ quality and safety performance. Several internal committees routinely evaluate corporate processes and quality systems, including the monitoring of key performance and quality indicators.

In 2023, Grifols received favorable outcomes from the audits and inspections carried out by global health authorities and organizations, evidence of its steadfast commitment to quality and safety. The company had no reported cases of regulatory non-compliance, monetary penalties, warnings or non-compliance with voluntary codes.

More details on Grifols’ Quality Policy

Supplier relations

Grifols Corporate Procurement Policy defines common guidelines and procedures for purchasing processes and supply strategies, assuring all acquired goods and services are founded on transparent, objective, timely and cost-effective decision making. This policy ensures a more structured, consistent and homogeneous framework for purchasing processes throughout the organization, bolstering risk management and compliance with all policies, procedures, and internal and external controls.

This policy places special emphasis on ethical, social, environmental and privacy criteria in alignment with the company’s health, safety and environmental policies. At the same time, it promotes the principles of sustainable procurement and topmost transparency in supplier relations, as defined in Grifols’ Human Rights and Sustainability Policies.

Ethical compliance and respect for human rights are cornerstones of Grifols’ activity. To this end, the company requires all employees, external collaborators involved in its procurement processes to adhere to several core principles: compliance with rules and regulations; integrity, impartiality and fairness; transparency, confidentiality; and due diligence. The policy also encourages the integration of social and environmental requirements, specifications and criteria in all purchasing processes.

In 2023, the company implemented a common procurement platform for all Grifols companies to bolster the group’s operational control and monitoring of supplier relations.

Grifols is also rolling out new procedures and IT systems to improve supplier assessment and due diligence processes, and other measures related to recent regulatory changes under the Proposal for a Directive of the European Parliament and the Council on Corporate Sustainability Due Diligence (CSDDD). This proactive approach boosts Grifols’ ability to adopt industry best practices and adapt its systems to reflect the latest regulatory shifts, as well as better detect ESG risks and develop measures to minimize and resolve them. Through these actions, the company seeks not only to mitigate risks, but to support suppliers less versed in critical ESG aspects, including respect for human rights and emissions reduction, among others.

More details on Grifols’ Procurement Policy.

Continuous improvement in the identification and management of risks in the value chain

Grifols strives to incorporate greater sustainability, resilience and efficiency in its supply chain. To this end, the Global Procurement team recently implemented an automated supplier management system to identify and manage potential ESG risks and improve visibility throughout the supply chain.

These robust analytical and data-driven resources allow Grifols to better detect supply risks and manage suppliers, leading to deeper connections and greater negotiation leverage. Using this system, the company expanded its monitoring scope of suppliers, which collectively account for over 50% of its procurement volume in 2023.

+390 supplier audits performed in 2023.

Supplier qualification and evaluation

Grifols’ Supplier Qualification Management System assures all raw materials are subject to rigorous and continuous evaluation processes, including plasma from external suppliers and critical non-plasma suppliers.

Grifols conducts routine supplier audits to guarantee compliance with GMP regulations and quality standards in all of its business units.

In parallel, its Corporate Procurement Policy defines common guidelines for purchasing processes and supply strategies in order to promote long-term relationships and compliance with ethical standards. The Global Procurement area ensures the application of supplier management practices and performance metrics, as well as defines which are significant and, in turn, subject to greater ESG scrutiny. For this segmentation, Grifols bases its analysis on their category and the annual expenditure generated with the supplier.

Summary of Audits in 2023 - GRIFOLS
Business unit/Area Type of supplier Result
No. of quality audits Favorable Not favorable Pending evaluation and final report
Plasma Procurement and Bio Supplies Raw materials suppliers 49 43 6 0
Distributors 3 3 0 0
Transport companies 4 4 0 0
Service suppliers 7 7 0 0
Biopharma Raw materials suppliers 98 94 4 0
Distributors 5 5 0 0
Transport companies 9 9 0 0
Service suppliers 32 31 1 0
Diagnostic Raw materials suppliers 28 24 0 4
Transport companies 2 2 0 0
Service suppliers 3 2 0 1
Grifols global subsidiaries Raw materials suppliers 1 1 0 0
Distributors 17 17 0 0
Transport companies 14 14 0 0
Service suppliers 11 11 0 0
Others Raw materials suppliers 67 67 0 0
Transport companies 1 1 0 0
Service suppliers 2 2 0 0
Summary of Audits in 2023 - BIOTEST
Plasma Procurement Raw materials suppliers 0 0 0 0
Service suppliers 4 4 0 0
Biopharma Raw materials suppliers 12 12 0 0
Service suppliers 24 24 0 0

Supplier relations: promoting ESG and human rights criteria

Code of conduct for suppliers

Grifols has a code of conduct defining the minimum standards of ethical, social and environmental behavior for its suppliers, which are also required to comply with applicable country-specific legislation in their regions of operation.

Framed from an ethical compliance perspective, the code of conduct regulates conflicts of interest, fair competition and commercial controls, the fight against bribery, corruption measures, the acceptance of gifts, and money laundering, as well as product quality and safety, clinical trials and animal welfare, among others. In terms of employee and human rights, it emphasizes respect for human rights and fair treatment, the elimination of forced or compulsory labor; and the effective abolition of child labor, among other criteria. At the same time, it addresses aspects related to health and safety, the environment and managerial systems.

Grifols code of conduct for suppliers is publicly available at our corporate website.
More information on Grifols’ human rights commitment: “Corporate Governance”.

Grifols’ supplier management model is continually being enhanced to ensure its main collaborators adhere to and conduct their operations in alignment with sustainable development policies and standards.

This effort includes compliance with human rights; efforts to reduce greenhouse gas emissions; climate-change risk management; circular economy strategy; strategies to advance the United Nations Sustainable Development Goals (SDGs); and other ESG criteria used to measure corporate responsibility along environmental, social and governance dimensions.

Due diligence in Grifols’ supply chain

Biotest and Haema rolled out new management systems to comply with the recently enacted German Supply Chain Due Diligence Act (LkSG). In this regard, both companies developed new processes while enhancing existing ones to identify and analyze humans-rights and environmental risks throughout their value chains.

These activities comprise both ad hoc and annual evaluations, with particular emphasis paid to risks with a higher likelihood of occurrence. Results are incorporated into the firms’ management processes, especially their supplier-management systems.

On a broader level, the Global Procurement team makes ongoing efforts to ensure the firm’s supplier-relation procedures align with the most recent regulatory shifts.

More information on Biotest’s regulatory compliance.

More information on Haema’s regulatory compliance: Haema.

Biopharma, a differential value chain

Each Grifols business unit has its own unique value chain. Biopharma–the unit responsible for producing Grifols’ plasma-derived medicines–is the most relevant, accounting for 85% of the firm’s total revenues and the majority of its critical suppliers.

Grifols’ value chain is characterized by the essential role of plasma donors (920,000-plus per year); lengthy production times (9-12 months); and rigorous controls in every stage of the value chain, both mandatory and voluntary.

From Donors

Plasma procurement

to Patients



Plasma collection

Only qualified donors

  • Grifols has a donor safety corporate policy in place to ensure the health and safety of donors, as well as to guarantee the highest quality of donated plasma for the benefit of patients.

Analysis of donated plasma

Screenings for viral antigens Or antibodies

  • Analysis per unit of plasma: hepatitis A, B and C, HIV, parvovirus B19, etc.
  • Use of NAT, ELISA and other highly sensitive techniques.
  • Laboratories approved by FDA, EMA and other global health authorities.

Inventory hold


  • New verification of samples to guarantee the absence of viral or pathogenic markers.


Quality management systems in manufacturing facilities

Production with suitable plasma

  • Production stages include fractionation or separation of proteins, purification, specific stages of viral inactivation, dosage and conditioning. Adherence to Good Manufacturing Practices (GMP).

Elimination of viruses and other pathogens

Every stage of the production process

  • Testing and elimination processes for potential pathogens, viral inactivation and virus removal techniques.Depending on the product, may also include pasteurization, heat treatment, solvent/detergent treatment and/or nanofiltration.

Sterile filling

Following purification

  • Sterilization and dosing executed with an exclusive system developed and patented by Grifols Engineering.


Product tracking and traceability

  • Identification of vials with a unique code and a retractable band on the capsule to ensure its inviolability and authenticity.
  • Packaging marked with a holographic seal to assure inviolability and authenticity. Assignation of unique and traceable numerical series to
    prevent counterfeiting.
  • PEDIGRI® system to provide healthcare professionals with detailed information on specific plasma used.

More information: “From Donors to Patients”.

Plasma Procurement Regulation

  • WHO: recommendations for the manufacture, control and regulation of human plasma for fractionation (WHO Technical Report Series, No. 941).
  • Directive 2002/98/CE, which establishes quality and safety standards for processes relating to human blood and its components.
  • EMA Guideline on Plasma-Derived Medicinal Products.
  • 21CFR Part 640: additional standards for human blood and blood products.
  • Local regulations in countries where hemoderivatives are distributed.
  • PPTA standards which Grifols adheres to voluntarily.
  • European Pharmacopoeia.
  • American Pharmacopoeia.

Biopharma Regulation

  • Good Pharmacovigilance Practices, EMA.
  • Code of Federal Regulations (CFR): 21 CFR 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 601, 610, 630 and 640.
  • Good Manufacturing Practices, Pharmaceutical Inspection Co-operation Scheme (PIC/S).
  • European Pharmacopoeia.
  • United States Pharmacopeia.
  • Local regulations in countries where hemoderivatives are distributed.

Internal control system

Grifols ensures a robust quality control and safety system through a highly qualified staff; rigorous process and product designs; innovative Grifols-engineered technologies; and complete traceability from plasma donation to commercialization. The company’s quality assurance area supervises the materials and procedures used at every stage of the supply chain. This oversight includes controls in manufacturing processes and final products; review and follow-up of manufacturing procedures to ensure compliance with GMPs; and systems to escalate relevant events and take corrective actions through Grifols Quality Committees, which evaluate key performance indicators and quality markers.

Grifols is a member of the National Donor Deferral Registry (NDDR), a voluntary self-regulatory initiative to guarantee the safety and quality of donated plasma, applicable to all U.S. donors.

More information

External certifications

  • External entities certify the quality systems of all Grifols’ production plants, including the manufacture of both medicines and medical devices.
  • Certifications of Good Business Manufacturing Practices from the European Union, the United States and other countries where required.
  • IQPP & QSEAL Certifications from the Plasma Protein Therapeutics Association (PPTA).
    • International Quality Plasma Program (IQPP) Certification, a voluntary standards program including the management of donors and plasma centers.
    • Quality Standards of Excellence, Assurance and Leadership (QSEAL) Certification, with voluntary membership and certification, applicable to the manufacture of plasma-derived medicines.

More information

Internal and external quality-control audits

  • Grifols’ leadership team defines and maintains the company’s quality management system, including routine in-house audits of plasma centers, laboratories, production facilities and warehouses to monitor quality standards and applicable regulation.
  • The Quality Audit area conducts routine reviews of all operations.
  • All plasma centers, manufacturing plants, warehouses and laboratories are routinely inspected by health authorities in the U.S. (FDA), Europe (EMA) and other countries in accordance with current regulations.
  • Plasma centers and fractionation plants are subject to regular PPTA audits.

Patients and healthcare professionals: relationships built on trust

Health, safety and pharmacovigilance measures

As outlined in its Quality Policy, Grifols identifies the critical attributes of its products and carries out exhaustive controls on the quality of raw materials, manufacturing processes, and finished product testing.

Grifols has pharmacovigilance agreements with all distributors, including those operating in countries with less advanced pharmacovigilance regulations, to ensure compliance with Grifols’ standards in this area.

The pharmacovigilance program monitors for any adverse effects or reactions resulting from its plasma-derived medicines, while its surveillance system detects adverse reactions stemming from the use of its medical and in vitro devices. Both programs feature systems to report safety issues and suspected cases of adverse reactions.

All activities and requirements of Grifols’ pharmacovigilance and surveillance systems are outlined in standard operating procedures and subject to routine reviews. The company conducts regular internal audits of these systems under its quality compliance protocols, which also undergo external inspections by the competent health authorities.

Grifols never outsources its pharmacovigilance and surveillance of medical and in vitro devices to third parties.

Packaging, leaflets and labeling

The information in Grifols’ product packages, leaflets and labels complies with the standards and regulations applicable in its countries of operation, the Good Manufacturing Practice (GMP) guidelines for pharmaceuticals, and country-specific regulations in other markets.

In terms of Grifols medical and in vitro devices, their labeling, instructions for the use of reagents, and instrument user and software manuals comply with country-specific regulations (EN ISO 15223, among others), and incorporate mitigating measures detected via medical-device risk management systems (EN ISO 14971 Medical Devices) or measures required by global health authorities. All printed material is translated to the corresponding language, updated as required and accessible to users.

Product recall system

The product recall system is governed by the corporate policy for patient and customer safety. Additionally, this system is developed through standardized work procedures and is internally audited by the company to verify its effectiveness and alignment with current regulations. It is also inspected by competent health authorities.

All Grifols teams involved in potential product recalls, whether voluntary or mandatory, receive specific training in proper incident management. Furthermore, Grifols conducts periodic product recall simulations to ensure that all crisis management procedures and protocols are functioning effectively and to identify any potential areas for improvement

The product claims and recall system includes procedures to notify healthcare authorities, patient associations and healthcare professionals regarding the potential risks of a recalled product. Grifols operates a customer service call center and has dedicated webpages for specific products to communicate potential risks. It also prohibits the use of any recalled product in clinical trials.

In 2023, Grifols did not have any mandatory product recalls due to quality or safety concerns. The company’s and Biotest voluntarily recalled two batches of products. Grifols’ stringent controls ensure comprehensive compliance with quality and safety standards.

Claims system

Grifols’ claims system, described in the corporate policy, registers and reviews all notifications received from healthcare centers, patients and users regarding consumer appraisals of possible quality issues. For medical devices, the management system for technical services is linked to the claims management system to ensure all client requests are evaluated.

When subsidiaries or authorized call centers receive a complaint regarding a Grifols medicinal product or service, they immediately notify the relevant production installation, ensuring all complaints are properly channeled and analyzed through the claims system.

The quality area of each business unit oversees the complaint process, which includes conducting the relevant investigations; verifying the implementation of corrective and preventive actions, if necessary; notifying relevant health authorities, if applicable; and informing the customer of the claim investigation’s findings.


1 per 97,895
units distributed
2022: 1 per 77,806 units distributed

1 per 559,298
diagnostic tests
2022: 1 per 482,302 diagnostic tests

Bio Supplies
1 per 2,777
units distributed
2022: No claims received

Other (Medicines)

1 per 14,972,662
units distributed
2022: 1 per 5,848,478
units distributed

Other (Medical devices)

1 per 50,005
units distributed
2022: 1 per 31,210
units distributed


1 per 26,111
units distributed
2022: 1 per 32,532
units distributed

Counterfeit drug prevention system

Plasma medicines are prescription drugs that are primarily administered in hospital settings. As such, counterfeit products pose a grave risk to public health.

Grifols collaborates with regulatory authorities to investigate and analyze suspected cases of counterfeit, and has an internal policy to prevent, detect and report counterfeit products. In this regard, any suspicious and identified cases of counterfeit medicines must be duly and expeditiously reported to the relevant authorities in adherence to the applicable regulations in force.

Grifols uses track-and-trace technology to comply with product serialization and aggregation specifications required in certain countries and regions. These requirements include marking vials with a unique code before any plasma product is sold, and marking containers with a holographic seal to guarantee their inviolability and authenticity.

Grifols conducts routine internal audits and inspections to confirm regulatory compliance, and performs due diligence on customers and distributors to verify they possess the requisite licenses to distribute products. Its anti-counterfeiting measures are also detailed in third-party contracts and quality agreements when applicable.

Since 2021, Grifols is unaware of any actions resulting in raids, seizures, arrests and/or the filing of criminal charges related to counterfeit products.

More information: Grifols’ Anti-Falsification Policy

Responsible marketing practices

Grifols ensures its promotional and educational collateral complies with applicable laws and regulations; aligns with industry policies and voluntarily adopted codes; adequately addresses the target audience and end users; and contains truthful, accurate, comprehensive and balanced information.

The company has a standard operating procedure–the Grifols Review Process (GRP)–that specifies all activities and responsibilities related to the approval, review and control of promotional and educational materials used to communicate its products and services. Representatives from the legal, medical and regulatory departments review and approve all marketing collateral using a GRP-adapted electronic system. Marketing material and contents are solely approved for specific uses and countries, and may only be used with no alterations. The contents of all promotional and educational materials are regularly reviewed to confirm their validity and compliance with the standards and codes in force.

The company delivers appropriate training on responsible marketing and sales practices in line with its Code of Conduct and Anti- Corruption Policy.

In 2023, only one marketing complaint was received and handled according to established procedures. The complaint did not result in any monetary impact or loss.

Materials reviewed

Materials approved

Overview of audits and inspections


Internal audits

256 (Grifols)

14 (Biotest)


Inspections by healthcare authorities and accredited inspection organisms

529 (Grifols)

9 (Biotest)


Favorable supplier audits

57 (Grifols)

4 (Biotest)


Internal audits

53 (Grifols)

20 (Biotest)


Inspections by healthcare authorities and accredited inspection organisms

22 (Grifols)

8 (Biotest)


Favorable supplier audits

139 (Grifols)

36 (Biotest)


Internal audits



Routine inspections by official institutions



Favorable supplier audits



Internal audits



Routine inspections by official institutions



Favorable supplier audits


Incidents related to the suspension, revocation or loss of any license or certification; warning letter, imposed suspension of any regulated activity**



Internal audits



Routine inspections by official institutions



* Includes inspections by health authorities and accredited inspection bodies, as well as in-house inspections.
** Includes Grifols and Biotest.
***Former Bioscience Division.
**** Others: includes Former Hospital Division.