How Pharmaceutical Companies Choose Qualified Suppliers

Under the FDA regulatory framework, it is important for pharmaceutical companies to evaluate qualified suppliers to ensure that the raw materials, components, and services used meet stringent quality and compliance standards to safeguard the efficacy and quality of pharmaceutical products.

Through systematic supplier evaluation, pharmaceutical companies can identify and select suppliers that consistently deliver high-quality products, reducing the risk of production interruptions and quality issues. In addition, continuous monitoring and reassessment of supplier performance helps maintain supply chain reliability and compliance, ensuring that the drug manufacturing process always meets the FDA's regulatory requirements. This not only protects the health and safety of patients, but also enhances the credibility and competitiveness of pharmaceutical companies in the marketplace. In this article, we share how pharmaceutical companies should choose compliant and reliable suppliers. ‍

Determine Needs and Criteria

Before evaluating suppliers' capabilities, pharmaceutical companies should identify specific needs and quality standards, including appropriate FDA regulations and guidance. For example, understand the types of materials or services needed, and identify the regulations (e.g., 21 CFR Part 820 quality system regulations) and other internal quality requirements that the supplier must meet.

This step involves identifying the quality and compliance standards for key raw materials, ingredients, equipment, or services, with a particular focus on the following areas:

• Manufacturing/production capabilities
• Quality standards and certifications
• Regulatory and compliance requirements
• Technical capabilities
• Customer service standards
• Delivery and cycle time
• Product lifecycle management‍

Supplier Assessment and Qualification

Once a pharmaceutical company has fully defined its needs, it engages with potential suppliers to assess their level of interest in partnering. Companies make clear requirements for suppliers interested in developing a potential partnership, and suppliers should be able to provide a statement of how they will fulfill the company's requirements, along with complete documentation to support these statements.

If a specific product is involved, the organization may ask the supplier to provide a sample for evaluation. The organization conducts a detailed assessment of the potential supplier, including a review of its quality management system, production capabilities, compliance history and financial position.

On-site audit: A site visit to the supplier's facility to evaluate its manufacturing processes and quality control system.

Document review: Review of quality management documents, certifications and compliance records provided by the supplier

Questionnaire survey: A detailed questionnaire is distributed to the supplier to collect information on their quality management and regulatory compliance

If the list of potential suppliers is long, it is recommended to narrow it down to no more than 5 companies so as to fully evaluate each candidate supplier and ensure that their documentation provides everything needed to conduct a thorough evaluation.

Supplier Selection and Approval

With a shortlist of the most suitable candidate suppliers, it is time to begin a more thorough evaluation of each supplier.

Begin by comparing each supplier's relative ability to meet your requirements with other suppliers. Based on the capabilities of the candidate suppliers, devise a digital rating system that applies to each requirement, as shown below. Simple and practical rating systems make comparisons between candidate suppliers easier.

Select qualified suppliers based on the results of the evaluation and conduct an internal approval process. Criteria for selection should include:

• Quality management capability
• Compliance
• Production capacity
• Cost effectiveness
• Stability of the supply chain

Before approving a supplier, companies need to ensure that all necessary contracts and agreements have been signed.

Establish and Maintain Supplier Relationships

To establish and maintain good supplier relationships, pharmaceutical companies should:

• Set up good communication mechanisms to ensure ongoing quality and compliance
• Communicate with suppliers regularly to address any quality issues or compliance risks in a timely manner
• Maintain transparent and open lines of communication so that suppliers can keep abreast of and respond to changes in pharmaceutical companies' needs and standards

Well-designed and managed supplier audits enable pharmaceutical companies to establish a number of critically crucial quality measures, such as:

• Risk-based supplier quality programs to meet current and future regulatory trends
• Audit and qualification criteria are required to evaluate new suppliers
• Internal regulatory responsibilities associated with suppliers
• Quality standards that suppliers need to meet in order to be consistent with FDA and the pharmaceutical company's own standards

Regular Monitoring and Reassessment

After qualifying a supplier, companies should monitor its performance regularly to identify and address all issues related to the products or services provided, including product quality, on-time delivery, and compliance, to ensure that the supplier consistently meets the FDA's regulatory requirements and the pharmaceutical company's quality standards.

It is recommended that the pharmaceutical company create a schedule for performing periodic reviews to address pre-approved review confirmation steps as well as potential problem areas observed during previous reviews. The frequency with which a company conducts periodic reviews should be determined based on the importance of the supplier's products and/or services to the final product and their track record of regulatory compliance.

Suppliers with a history of problems should be closely monitored and, if necessary, Corrective and Preventive Actions (CAPAs) should be taken to address identified problems and continuously improve supplier management.

Proper selection of suppliers is a crucial part of risk management for pharmaceutical companies. Proregulations helps pharmaceutical companies identify and finalize quality suppliers, optimize their supply systems and continuously improve risk management efficiency. If you are interested in our services or need more details, please contact us.