Supplier Qualification: Definition, Process, and Guidelines

A supplier is an entity that provides goods, components, or services to a company, ensuring the necessary materials or expertise for business operations. Supplier qualification is a systematic process of evaluating, selecting, and approving suppliers to ensure they meet predefined quality, regulatory, operational, and business requirements.

Supplier qualification involves identifying and pre-screening suppliers based on business and regulatory criteria, gathering documentation such as certifications and compliance records, and requesting information to assess capabilities and risks. Further steps in supplier qualification include conducting risk assessments, performing on-site audits, reviewing quality systems, approving suppliers, negotiating contracts, onboarding vendors, monitoring performance, and periodically requalifying or deactivating suppliers.

The life sciences industry follows strict guidelines, standards, and regulations for supplier qualification. Key regulations include FDA 21 CFR Part 820 and ISO 13485 for medical devices, EU GMP, and ICH Q10 guidelines for pharmaceuticals.

Companies use QMS software to streamline supplier qualification, optimize processes, and improve compliance tracking. SimplerQMS, specialized life sciences QMS software, provides supplier management features such as document control, qualification tracking, audits, and performance monitoring.

To learn more about how SimplerQMS can help streamline supplier qualification and other QMS processes, book a demo today!

What is Supplier Qualification?

Supplier Qualification (SQ), or Vendor Qualification (VQ), is the process of evaluating, selecting, and approving suppliers, vendors, and contractors to ensure they can provide goods or services that meet a company’s required standards.

The supplier qualification process verifies compliance with quality, regulatory, business, and operational requirements for manufacturing, providing, or delivering materials, components, or services.

Supplier Qualification plays a crucial role in the life sciences industries including pharmaceuticals, biotechnology, and medical devices by ensuring that materials, devices, components, and services comply with strict industry regulations. Supplier Qualification helps ensure consistent product quality, regulatory compliance, and a reliable supply chain.

What is the Supplier Qualification Process?

The supplier qualification process, also known as the vendor qualification process, is a systematic evaluation of a supplier’s capabilities, quality control measures, compliance with regulatory requirements, and operational requirements to ensure alignment with industry-specific requirements.

Below are the key steps involved in the supplier qualification process.

1. Identify and Pre-Screen Suppliers: Identify, assess, and evaluate potential suppliers based on industry requirements, business needs, and internal quality standards.
2. Classify Suppliers Based on Impact: Classify each supplier as either quality-critical or standard based on their potential impact on product quality and regulatory compliance.
3. Gather Preliminary Documentation: Collect essential documents such as certifications, regulatory approvals, and compliance records to verify the supplier’s credibility.
4. Request Information and Proposals: Assess supplier capabilities, pricing, and terms through Request for Information (RFI) and Request for Proposal (RFP).
5. Conduct Risk Assessments: Analyze supplier risks, including financial stability, operational reliability, and quality control measures.
6. Perform On-Site Audits: Conduct supplier audits to verify manufacturing practices and compliance with regulations.
7. Review Quality Systems and Documentation: Assess quality management systems, Standard Operating Procedures (SOPs), and compliance records.
8. Approve Qualified Suppliers: Select suppliers that meet all industry-specific regulatory requirements.
9. Negotiate Contracts and Quality Agreements: Define expectations, roles, and compliance requirements in formal agreements to understand mutual understanding.
10. Onboard and Train Suppliers: Facilitate seamless integration into the supply chain through training and guidelines.
11. Monitor and Manage the Performance of Suppliers: Regularly evaluate supplier performance, quality, and compliance to ensure ongoing adherence to requirements.
12. Requalify or Deactivate Suppliers: Reassess suppliers periodically or discontinue those that no longer meet requirements.

1. Identify and Pre-Screen Suppliers

The supplier qualification process begins with identifying and screening potential suppliers to ensure they meet quality, compliance, business, and operational standards.

Market research, including industry databases, supplier directories, and regulatory networks, helps identify reputable suppliers. Reviewing supplier portfolios ensures their products or services align with business needs.

Supplier pre-screening evaluates reputation, financial stability, operational capacity, and regulatory compliance. Reputation is assessed through past performance, client testimonials, and reviews. Financial stability is verified via financial statements and risk ratings to confirm long-term viability.

Operational capacity is determined by assessing production capabilities and quality consistency. Regulatory compliance requires certification verification or assessment of adherence to requirements set by local, regional, or national authorities.

By thoroughly evaluating suppliers, businesses secure high-quality partnerships and maintain a strong, compliant supply chain.

2. Classify Suppliers Based on Impact

After identifying and pre-screening potential suppliers, the next step is to classify each supplier based on their significance to product quality and regulatory compliance.

Suppliers are generally categorized as either quality-critical or standard. This supplier classification depends on the extent to which the supplier’s products or services influence product safety, efficacy, and regulatory adherence.

Quality-critical suppliers provide materials, components, or services that directly impact the finished product’s quality or regulatory status, such as active ingredients, primary packaging, or critical testing services. Quality-critical suppliers require stricter oversight, including thorough qualification, continuous performance monitoring, and periodic audits.

Standard suppliers deliver goods or services with minimal or no direct impact on product quality or patient safety, such as office supplies or non-critical maintenance services. While still important to operational efficiency, standard suppliers typically require less rigorous qualification and monitoring activities.

This supplier classification supports a risk-based approach to supplier qualification, auditing, and performance reviews, ensuring that resources are allocated appropriately based on supplier impact.

3. Gather Preliminary Documentation

Gathering preliminary documentation helps ensure potential suppliers meet compliance, quality, and operational standards before further evaluation. This step eliminates non-compliant vendors, reducing risks and saving time.

Essential documents include company profiles, business licenses, certifications, and regulatory documentation. These documents confirm supplier legitimacy, operational scope, and regulatory adherence.

Certifications such as cGMP (Current Good Manufacturing Practice), ISO standards (e.g., ISO 9001, ISO 13485), and national regulatory certifications confirm adherence to industry-specific and regional compliance standards. Product-specific documentation, such as FDA compliance letters, EMA approvals, and CE marking under the EU MDR, ensures alignment with international regulatory requirements.

A supplier qualification questionnaire gathers data on quality management systems (QMS), past performance, and risk management strategies. Reviewing historical performance data, including audit reports and incident records, provides insights into supplier reliability and consistency. A strong QMS evaluation confirms adherence to industry best practices and quality standards.

Systematic documentation collection and verification strengthens supplier qualification, removes high-risk vendors, and helps build a compliant, resilient supply chain.

4. Request Information and Proposals

Requesting information and proposals helps identify vendors that meet technical, quality, cost, and regulatory requirements. This process increases transparency in pricing, capabilities, and lead times for better decision-making.

Clearly defining and communicating the scope of work, technical specifications, and quality expectations ensures suppliers understand requirements. Outlining regulatory compliance requirements, including FDA, EMA, cGMP, and ISO, filters out non-compliant vendors.

Issuing a Request for Information (RFI), Request for Proposal (RFP), or Request for Quotation (RFQ) gathers essential data. RFIs provide insights into supplier capabilities and market conditions. RFPs request technical, operational, and financial details from potential suppliers. RFQs focus on pricing including cost breakdowns, discounts, and payment terms. These documents assess manufacturing capabilities, lead times, supply chain reliability, and overall cost-effectiveness.

Comparing responses based on quality, pricing, compliance, and operational fit ensures alignment with business objectives. A structured review process optimizes supplier selection, minimizes risks, and enhances supply chain efficiency.

5. Conduct Risk Assessments

Risk assessment is the process of identifying, evaluating, and ranking potential risks that could negatively impact an organization’s operations. Developing control measures and strategies helps mitigate potential disruptions.

Conducting a supplier risk assessment identifies and mitigates risks related to quality, compliance, financial stability, and supply chain resilience. Suppliers with quality issues, process deviations, or inconsistent production create long-term operational threats. Analyzing past performance data, audit reports, and past incidents reveals non-compliance patterns, delivery failures, and customer complaints, enabling informed decision-making.

Regulatory non-compliance presents significant risks in industries requiring FDA, EMA, cGMP, and ISO adherence. Suppliers who fail to meet compliance requirements, risk legal penalties, supply chain disruptions, and product recalls. Capacity constraints and supply chain weaknesses impact business continuity. Production delays and resource shortages disrupt operations, impacting overall efficiency and profitability.

6. Perform On-Site Audits

Performing on-site audits evaluates manufacturing processes, facility conditions, and quality control measures. On-site audits verify compliance with regulatory frameworks and internal quality policies. Conducting on-site audits helps ensure suppliers meet industry standards.

A successful supplier audit requires strategic planning. Defining the audit scope, creating a checklist, and gathering essential documentation streamline the auditing process. Key areas of focus include production workflows, equipment maintenance, hygiene protocols, and material traceability.

Auditing suppliers ensures compliance with quality and regulatory requirements. Audits involve interviewing personnel, observing operations, and reviewing SOPs for consistency. Documenting findings, identifying non-conformities, and recommending corrective actions strengthen compliance and efficiency. Regular audits help prevent quality failures, reduce risks, and build strong supplier relationships.

7. Review Quality Systems and Documentation

Perform a comprehensive review of quality systems and documentation to ensure regulatory compliance, accuracy, and consistency in processes. Proper documentation is essential for maintaining traceability, accountability, and quality assurance in regulated industries.

Start by reviewing quality manuals, standard operating procedures (SOPs), batch records, and validation reports. These documents provide critical guidelines for manufacturing, testing, and compliance. Ensure that SOPs are current, batch records are accurate, and validation reports confirm process reliability to meet industry-specific requirements.

Strong documentation and change control systems determine compliance integrity.  A robust change control system ensures that any modifications to equipment, processes, or materials are thoroughly reviewed, documented, and approved. Poor documentation or unapproved changes can lead to compliance failures, product recalls, and regulatory penalties.

Traceability and accountability ensure seamless tracking and regulatory audits. Proper documentation of materials, procedures, and decisions strengthens compliance, operational efficiency, and risk management, safeguarding product safety and quality.

8. Approve Qualified Suppliers

Approving qualified suppliers ensures high-quality standards, regulatory compliance, and supply chain reliability. Only vendors that meet critical material, component, or service requirements should be approved as qualified suppliers. Supplier approval requires compiling audit findings, assessing risk factors, and verifying quality and compliance. Vendors should meet predefined performance, safety, and reliability criteria.

An approved supplier is a vendor that has passed on-site audits, documentation reviews, and risk assessments, demonstrating compliance with applicable regulatory requirements, and internal quality standards.

Approved suppliers that meet the required qualifications are formally included in the approved supplier list. The Approved Supplier List (ASL) is a controlled document that includes prequalified vendors authorized to supply essential products or services.

Maintaining an up-to-date approved supplier list is a regulatory requirement that helps reduce sourcing risks, ensures product quality, and strengthens supplier relationships. Regular reviews and updates of approved supplier lists enhance supply chain efficiency, regulatory compliance, and operational success.

9. Negotiate Contracts and Quality Agreements

Contract negotiations and quality agreements ensure regulatory compliance, quality assurance, and supplier accountability. Well-defined agreements help maintain product consistency, mitigate risks, and strengthen supply chain reliability.

A quality agreement is a legally binding document that defines quality expectations, regulatory responsibilities, and performance standards between a manufacturer and a supplier. It includes performance metrics, CAPA protocols, and audit schedules to ensure compliance with applicable regulatory and customer requirements.

Contract negotiations establish pricing structures, quality expectations, and compliance responsibilities. Clear communication channels, confidentiality agreements, and dispute resolution procedures prevent misunderstandings and enhance collaboration.

Strong contracts and quality agreements enforce supplier accountability, ensure regulatory adherence, and maintain business stability. Regular contract and quality agreement reviews support improvement and risk management. These reviews ensure compliance with evolving regulations, protecting product integrity and business reputation.

10. Onboard and Train Suppliers

Supplier onboarding and training facilitate integration into the supply chain, ensure compliance with quality standards, and align with regulatory requirements. A structured integration process improves supplier performance, reduces risks, and maintains product quality.

Approved suppliers should be integrated into supply chain systems, gaining access to procurement platforms, quality control tools, and reporting mechanisms. Clearly defining product specifications, documentation requirements, and delivery timelines minimizes inconsistencies.

Comprehensive training on quality standards, applicable regulatory requirements, and reporting procedures ensure adherence. Training suppliers on recipient-specific requirements related to risk management, CAPA, and audit preparedness enhances compliance and operational consistency.

Regular communication and performance reviews aim to assess supplier performance, resolve issues, and reinforce quality expectations. Ongoing engagement strengthens supplier relationships, improves supply chain reliability, and ensures compliance with evolving regulations.

Effective supplier onboarding and training enhance supply chain efficiency, regulatory compliance, and business success, safeguarding product integrity and customer satisfaction.

11. Monitor and Manage the Performance of Suppliers

Supplier performance monitoring and management ensure ongoing compliance with contractual commitments and critical performance standards. Proactive supplier oversight reduces risks, strengthens partnerships, and maintains supply chain reliability.

Verification of purchased products ensures that goods or services received from suppliers meet predefined specifications, quality criteria, and regulatory requirements before further use. This step serves as a critical control point in supplier qualification and ongoing oversight.

Performance monitoring tools, including supplier scorecards and key performance indicators (KPIs), measure quality, delivery timelines, and customer satisfaction. Data-driven insights gathered from KPIs assess supplier reliability and identify risks early.

Periodic re-audits and performance reviews evaluate adherence to quality and operational standards. Regular assessments help detect non-conformities, process inefficiencies, and improvement areas before they escalate.

Corrective action and preventive action (CAPA) plans to address quality deviations, regulatory infractions, and supply chain disruptions when such issues escalate to CAPA status. Enforcing corrective measures ensures compliance, minimizes risks, and strengthens supply chain resilience.

Effective supplier monitoring and management sustain product quality, regulatory compliance, and cost efficiency, supporting a strong, transparent, and reliable supplier network for long-term success.

12. Requalify or Deactivate Suppliers

Supplier requalification or deactivation ensures a high-quality, reliable supply chain. Regular assessment of suppliers is a requirement as per FDA regulations, EU GMP guidelines, ISO 13485, ICH Q10, and other industry requirements.

Scheduled audits and risk assessments evaluate suppliers’ ongoing quality, compliance, and performance. Suppliers meeting regulatory and contractual obligations remain on the approved supplier list.

Continuous improvement relies on performance feedback, process enhancements, and collaborative problem-solving. Strong supplier relationships improve innovation, cost efficiency, and reliability.

Clear deactivation criteria address vendors failing to meet quality or compliance requirements. Persistent quality failures, regulatory violations, or supply disruptions may require termination to protect product integrity, patient safety, and business operations.

Regular supplier requalification or deactivation maintains compliance, reduces risks, and supports long-term operational success.

What are the Products and Services Requiring Supplier Evaluations in Life Sciences?

Products and services that directly or indirectly impact product safety, efficacy, and regulatory compliance are considered quality critical in the life sciences industry. These products or services should be sourced from suppliers who meet strict evaluation criteria, including compliance with regulations, strong quality assurance practices, and effective risk management.

Examples of quality critical products requiring supplier evaluations in life sciences are listed below.

• Active Pharmaceutical Ingredients (APIs): APIs should be sourced from suppliers who comply with ICH Q7 guidelines, ensuring adherence to GMP, traceability of raw materials, and prevention of contamination and cross-contamination.
• Excipients and Raw Materials: Excipients and raw materials should meet EXCiPACT or IPEC-GMP standards, undergo risk-based supplier assessments, and comply with pharmacopeial standards (USP, Ph. Eur., JP) to ensure consistency and safety.
• Medical Devices and Components: Suppliers of medical devices and components should adhere to ISO 13485 standards, ensure compliance with FDA 21 CFR Part 820 (Quality System Regulation), and obtain CE marking for European market access.
• Laboratory Reagents and Consumables: Laboratory reagents should be sourced from ISO 17025 accredited suppliers and validated for use in GLP/GMP environments.
• Packaging, Labeling, and Printing Materials: Suppliers should comply with EU MDR and UDI regulations, meet FDA 21 CFR Part 211 requirements, implement serialization and tamper-evident measures per FMD and DSCSA depending on product type, regulatory applicability, and the markets in which the products are sold.

Examples of services requiring supplier evaluations are listed below.

• Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs): CROs should comply with ICH E6 (GCP) for clinical research, while CMOs should adhere to GMP guidelines, undergo vendor qualification audits, and demonstrate a track record of regulatory compliance.
• Transport and Cold Chain Logistics: Suppliers should comply with GDP regulations, ensure proper validation of shipping conditions for biologics and vaccines, and implement real-time monitoring systems to maintain product integrity.
• Pest Control and Facility Hygiene Services: Suppliers should adhere to GMP facility maintenance guidelines, implement non-contaminating pest control methods in cleanroom environments, and undergo regular audits for compliance validation.
• Calibration and Equipment Maintenance: Calibration and maintenance providers should be ISO 17025 accredited, ensure GMP-compliant periodic calibration of critical equipment, and maintain detailed traceable calibration records.

What are the Guidelines and Requirements for Supplier Qualification?

Requirements for supplier qualification ensure that vendors meet regulatory, quality, and operational standards before approval for procurement.

Key requirements for supplier qualification in life science industries are listed below.

• Regulatory Compliance and Certifications: Suppliers of pharmaceuticals are expected to demonstrate regulatory compliance and hold relevant certifications. For pharmaceutical suppliers, this includes adherence to ICH Q7, EU GMP, and FDA 21 CFR Part 211. Medical device suppliers are expected to comply with ISO 13485 and 21 CFR Part 820. Logistics and storage providers should follow Good Distribution Practices (GDP).
• Quality Management Systems: Suppliers are required to maintain validated processes in accordance with EU GMP Chapter 5.27. They should ensure product traceability in line with ISO 13485 (Clauses 7.4, 7.1, and 8.4) and implement performance monitoring systems as outlined in ICH Q7.
• Risk Management Integration: Supplier qualification should incorporate a risk-based approach, as detailed in ICH Q9 for pharmaceuticals and ISO 14971 for medical devices. Suppliers should be categorized based on the potential impact their materials or services have on product quality and patient safety (e.g., API suppliers vs. indirect material providers). The outcomes of risk assessments should guide the scope of qualification activities, including audits, testing, and document reviews.
• Financial Stability: Suppliers are expected to provide financial statements, credit reports, and risk evaluations to confirm long-term viability. This aligns with FDA 21 CFR Part 211.34 and represents industry best practices in due diligence.
• Manufacturing and Operational Capabilities: On-site audits and performance evaluations, as recommended in EU GMP Annex 15, ISO 13485 Clauses 6.4, 7.5.6, and ICH Q9 verify production capacity, equipment maintenance, and quality control processes.
• Supply Chain Reliability: Vendors should ensure consistent lead times and maintain raw material traceability, in compliance with ICH Q7 for APIs. Suppliers should implement contingency planning strategies aligned with ISO 22301 for business continuity management.
• Ethical and Sustainability Standards: Vendors should uphold ethical sourcing, environmental sustainability practices, and corporate social responsibility (CSR) commitments as outlined in EU GMP Annex 16, Section 1.7.2. This includes adherence to ethical labor standards, anti-bribery policies, and environmental management systems such as ISO 14001.

GDP Supplier Qualification Requirements

GDP supplier qualification guidelines define the process for assessing, approving, and monitoring suppliers to ensure compliance with Good Distribution Practice (GDP) standards. These guidelines help maintain the integrity, safety, and quality of pharmaceutical products throughout the supply chain.

The main requirements for supplier qualification under GDP standards are outlined below.

• Supplier Selection and Approval (EU GDP Guidelines – Chapter 5.2): Suppliers should be assessed for their ability to comply with GDP, including storage and transportation conditions.
• Ongoing Supplier Monitoring (EU GDP Guidelines – Chapter 6.3): Periodic requalification, performance reviews, and deviation tracking should be implemented for GDP compliance.
• Quality Agreements (EU GDP Guidelines – Chapter 7.1): Contracts between parties are expected to define GDP responsibilities, risk management protocols, and compliance expectations.
• Temperature-Controlled Supply Chain (EU GDP Guidelines – Chapter 9.2): Suppliers handling temperature-sensitive pharmaceuticals should have validated cold chain management systems to prevent deviations and product degradation.

GMP Supplier Qualification Requirements

GMP supplier qualification guidelines define the process for assessing, approving, and monitoring suppliers to ensure compliance with Good Manufacturing Practice (GMP) standards. These guidelines uphold the quality, safety, and efficacy of pharmaceutical products.

The key requirements for vendor qualification under GMP standards are detailed below.

• Outsourced Activities (EU GMP – Chapter 7): Manufacturers should implement a formal supplier qualification process, ensuring compliance with GMP through audits, quality agreements, and continuous performance monitoring.
• Starting Materials (EU GMP – Chapter 5.29): Verification of starting materials’ quality and origin is required via supplier audits, risk-based assessments, and testing to prevent contamination and ensure consistency.
• Supplier Audits and Risk-Based Assessments (EU GMP – Chapter 5.29 and Annex 15): Regular audits and risk-based assessments are required to evaluate supplier performance, material quality, and GMP adherence.
• Quality Agreements and Responsibilities (EU GMP – Chapter 7.11): Written quality agreements should be established, defining GMP responsibilities, testing requirements, and compliance obligations.
• Ongoing Supplier Performance Monitoring (EU GMP – Chapter 8.14): Continuous assessment of supplier performance is necessary to address quality issues, deviations, and regulatory concerns, ensuring compliance and supply chain integrity.

FDA Supplier Qualification Requirements

FDA supplier qualification requirements ensure that pharmaceutical and medical device manufacturers only procure materials and services from approved suppliers that meet Current Good Manufacturing Practice (cGMP) regulations to maintain product safety, quality, and efficacy.

The requirements for supplier qualification according to FDA guidelines are outlined below.

• Supplier Selection and Evaluation (21 CFR 820.50 and 211.84): Manufacturers should establish procedures for supplier qualification, risk-based audits, and performance assessments to verify compliance with FDA regulations.
• Quality Agreements (21 CFR 820.50(b) and 211.84(d) (2)): Formal quality agreements are expected to define supplier responsibilities, compliance obligations, and material quality specifications.
• Component and Material Testing (21 CFR 211.110 and 820.80): All incoming materials and components should undergo sampling, testing, and verification before use in production.
• Change Control and Supplier Notification (21 CFR 211.100(a) and 820.30(i)):  Suppliers should notify manufacturers of any changes in materials, processes, or facilities that may impact product quality or regulatory compliance.
• Ongoing Supplier Monitoring (21 CFR 211.180(e) and 820.70): Continuous supplier performance monitoring, deviation tracking, and quality evaluations should be conducted to maintain compliance.

ISO 13485 Supplier Qualification Requirements

ISO 13485:2016 is a quality management system (QMS) standard specifically designed for medical device manufacturers and their suppliers.  Supplier qualification under ISO 13485 involves a structured process for evaluating, approving, and monitoring external providers to ensure that all purchased materials, components, and services consistently meet applicable regulatory and quality requirements.

The key requirements for supplier qualification under ISO 13485:2016 are outlined below.

• Supplier Selection and Evaluation (Clause 7.4.1): Organizations should establish documented procedures for selecting and assessing suppliers based on quality, compliance, and risk level.
• Risk-Based Supplier Management (Clause 7.1 & 7.4.1): A risk-based approach is recommended to determine the level of control needed, based on the potential impact on device safety and performance.
• Quality Agreements and Supplier Responsibilities (Clause 4.1.5 & 7.4.3): For outsourced processes, control should be maintained through documented agreements that define roles, expectations, and change control requirements.
• Supplier Performance Monitoring (Clause 7.4.1 & 8.4): Suppliers should be continuously monitored and re-evaluated based on performance metrics such as delivery reliability, non-conformities, and audit outcomes. Action should be taken when performance declines.
• Control of Nonconforming Product (Clause 8.3): Procedures should be in place to detect, record, and manage nonconforming goods, including communication with suppliers and implementation of corrective actions.
• Change Control and Supplier Notification (Clause 7.4.2): Suppliers are expected to notify the organization of significant changes that may impact quality or compliance. Such changes should be assessed and approved before implementation.
• Traceability and Documentation (Clause 4.2.4 & 7.5.9.2): Comprehensive records of supplier assessments, agreements, and performance should be maintained to ensure traceability and demonstrate regulatory compliance, especially for critical suppliers.

ICH Supplier Qualification Requirements

The ICH (International Council for Harmonization) guidelines provide a global framework for vendor qualification, ensuring that suppliers meet pharmaceutical quality, safety, and efficacy standards through risk-based assessments and continuous oversight.

The requirements for vendor qualification according to ICH standards are detailed below.

• Pharmaceutical Quality System (ICH Q10): Vendor qualification is a core component of the pharmaceutical quality system, focusing on risk management, lifecycle management, and supplier oversight to ensure consistent quality and compliance.
• Good Manufacturing Practice for APIs (ICH Q7): API manufacturers should implement a supplier qualification process, including risk-based audits, quality agreements, and change control procedures, to ensure material consistency and regulatory compliance.
• Quality Risk Management (ICH Q9): A structured risk management approach should be used to assess and mitigate supplier-related risks, ensuring vendor selection and approval align with product quality and regulatory expectations.
• Pharmaceutical Development (ICH Q8): Encourages a science and risk-based approach to supplier qualification, ensuring that vendors consistently provide raw materials that meet predefined quality specifications.
• Good Clinical Practice (GCP) Compliance (ICH E6 (R2)): Vendor qualification is critical in clinical trials, requiring sponsors to implement risk-based quality management, monitor contract research organizations (CROs), and ensure compliance with GCP standards.

USP <1083> Supplier Qualification Requirements

The USP <1083> General Chapter provides a risk-based framework for supplier qualification in the pharmaceutical industry, ensuring that manufacturers procure materials and services from reliable vendors that meet quality, safety, and regulatory standards.

The requirements for supplier qualification as defined in USP <1083> are summarized below.

• Supplier Qualification and Assessment (USP <1083> Section 4): Establishes a structured qualification process, including risk-based evaluations, supplier audits, quality agreements, and ongoing performance monitoring to ensure compliance with industry standards.
• Supply Chain Integrity (USP <1083> Section 5): Requires supplier traceability, verification, and documentation to mitigate risks such as counterfeit materials, contamination, and supply chain disruptions.
• Supplier Performance Monitoring (USP <1083> Section 6): Emphasizes continuous supplier evaluation, requiring periodic requalification based on risk assessments and historical performance to maintain product quality and regulatory compliance.

Ph. Eur. Supplier Qualification Requirements

The European Pharmacopoeia (Ph. Eur.) provides quality standards for pharmaceutical substances, excipients, and preparations, including guidelines for supplier qualification to ensure compliance with Good Manufacturing Practice (GMP) and product quality requirements.

The main requirements for vendor qualification according to Ph. Eur. standards are outlined below.

• Raw Material and Excipient Compliance (Ph. Eur. General Notices and Monographs): All raw materials, active pharmaceutical ingredients (APIs), and excipients should conform to Ph. Eur. monograph specifications to ensure consistent quality and regulatory compliance.
• Supplier Qualification and Risk-Based Assessment (Ph. Eur. Chapter 5.1.1):  Manufacturers should implement a supplier qualification process, including risk-based assessments, audits, and documentation reviews to verify compliance with pharmacopoeial standards.
• Good Distribution Practice (GDP) Compliance (Ph. Eur. Chapter 5.3): Vendors involved in storage, transportation, and distribution should comply with GDP principles, ensuring that materials are handled under appropriate conditions to prevent degradation or contamination.
• Quality Control and Testing (Ph. Eur. Chapter 2): Suppliers should provide certificates of analysis (CoA), validation data, and batch testing results to demonstrate compliance with Ph. Eur. testing methods and quality requirements.
• Traceability and Documentation (Ph. Eur. Chapter 5.6): Manufacturers should ensure full traceability of materials, requiring suppliers to maintain detailed documentation for material origins, quality control, and supply chain integrity.

ISO 9001 Supplier Qualification Requirements

ISO 9001 is a quality management system (QMS) standard that establishes requirements for supplier qualification, risk assessment, and continuous improvement to ensure product and service consistency. Supplier qualification under ISO 9001:2015 involves evaluating and monitoring vendors to maintain quality, regulatory compliance, and operational efficiency.

The requirements for Supplier Qualification under ISO 9001 standards are detailed below.

• Supplier Selection and Evaluation (ISO 9001:2015 – Clause 8.4.1): Organizations should set criteria for selecting suppliers, ensuring they meet quality, reliability, and regulatory compliance standards.
• Risk-Based Supplier Management (ISO 9001:2015 – Clause 6.1): A risk-based approach is expected to be applied to assess supplier risks and implement preventive measures for a stable and compliant supply chain.
• Quality Agreements and Supplier Responsibilities (ISO 9001:2015 – Clause 8.4.2): Formal agreements should define supplier responsibilities, quality standards, and compliance obligations to maintain consistent material and service quality.
• Supplier Performance Monitoring (ISO 9001:2015 – Clause 9.1.3): Organizations are encouraged to conduct ongoing evaluations of supplier performance through audits and tracking to ensure quality and process improvement.
• Nonconforming Material Handling (ISO 9001:2015 – Clause 8.7): Procedures should be in place to detect, document, and manage nonconforming materials to prevent defective products from affecting operations.
• Change Control and Supplier Notification (ISO 9001:2015 – Clause 8.5.6): Suppliers should inform organizations of any changes in materials, processes, or services that may impact product quality or regulatory compliance.
• Traceability and Record-Keeping (ISO 9001:2015 – Clause 7.5.3): Organizations should maintain detailed supplier qualification records, including audit reports, quality data, and compliance documentation, to ensure traceability and regulatory adherence.

ISO 17025 Supplier Qualification Requirements

ISO 17025 sets the standard for testing and calibration laboratories and outlines requirements for supplier qualification to ensure that laboratories produce accurate, reliable, and traceable results. Supplier qualification under ISO 17025 ensures that laboratories meet high standards for competence, calibration, and testing.

The essential requirements for Supplier Qualification under ISO 17025 standards are outlined below.

• Supplier Selection and Evaluation (ISO 17025 – Clause 6.6.2): Laboratories should assess and select suppliers based on their ability to meet specific technical, regulatory, and quality standards required for testing or calibration.
• Purchasing Information (ISO 17025 – Clause 7.4.1): The laboratory should specify the requirements for products and services purchased, including the supplier’s ability to meet the required technical specifications.
• Supplier Audits and Performance Monitoring (ISO 17025 – Clause 7.6): Regular audits and performance reviews of suppliers should be conducted to verify that materials or services meet the laboratory’s quality criteria.
• Control of Non-Conforming Supplies (ISO 17025 – Clause 7.9): Laboratories should have procedures in place to address any non-conforming products or services provided by suppliers, ensuring corrective actions are taken.
• Calibration and Equipment Qualification (ISO 17025 – Clause 5.6): Calibration services provided by suppliers should meet ISO 17025 standards to ensure the accuracy and traceability of measurements used in laboratory testing.
• Supplier Change Control (ISO 17025 – Clause 7.4.2): Any changes in the supplier’s products, processes, or services should be reviewed for compliance, with appropriate controls established to ensure continued reliability.

What Are the Key Strategies for Risk-Based Supplier Monitoring?

Effective risk-based supplier monitoring requires tailored strategies based on the supplier’s risk level to ensure regulatory compliance, quality control, and supply chain stability.

This approach is especially crucial for quality-critical suppliers, whose materials, components, or services have a direct impact on patient safety, regulatory outcomes, or product performance. Quality-critical suppliers require more intensive oversight and monitoring compared to standard or low-risk vendors.

Depending on their risk level, suppliers can be grouped into the categories listed below.

• Low-Risk Suppliers: Conduct due diligence and use questionnaires to assess supplier capabilities, financial stability, and compliance with standards. Regular performance reviews and reports help track ongoing risk.
• Medium-Risk Suppliers: Implement regular audits, track performance metrics, and establish clear communication channels for issue resolution. Periodic evaluations help mitigate risks related to quality, delivery, and regulatory compliance.
• High-Risk Suppliers (Quality-Critical): Perform on-site audits, detailed inspections, and assessments of processes, quality control, and safety practices. Close collaboration and continuous monitoring are essential to identify and address risks proactively.

How Does QMS Software Enhance Supplier Management?

QMS software enhances supplier management by streamlining supplier qualification, approval, and ongoing performance monitoring, ensuring compliance with regulatory requirements like ICH Q10, FDA 21 CFR Part 820, ISO 9001, ISO 13485, GMP guidelines, EU MDR, and more.

QMS software includes capabilities such as supplier qualification, annual supplier re-qualification, yearly review, audits, document control, and performance monitoring. Key features like risk assessment, automated workflows, and centralized documentation improve supplier oversight and reduce compliance risks.

SimplerQMS offers comprehensive QMS software for life science companies, including robust supplier management functionalities.

Beyond supplier management module, SimplerQMS supports various QMS processes, including document control, training management, change control, complaint handling, audit management, nonconformance and deviation management, CAPA management, and more.

The SimplerQMS platform is built to streamline quality management processes and help comply with regulatory requirements such as ICH Q10, FDA 21 CFR Part 820, FDA 21 CFR Part 211, ISO 13485:2016, EU GMP, WHO GMP, PIC/S GMP, EU MDR, and ISO 9001:2015.

Take control of your supplier management. Book a demo today to see how SimplerQMS can streamline your supplier management and many other QMS processes.