In order to ensure the quality of pharmaceutical products, a robust supplier quality management system is required. It is in a pharmaceutical manufacturer’s best interest to ensure that its service and material suppliers are providing the highest quality products and services while also conforming to pre-established requirements. Research indicates that fewer than 1 in 5 companies have a robust supplier quality management process. Therefore, monitoring and evaluating suppliers effectively plays a crucial role in maintaining product quality and patient safety. This article explores how quality professionals can establish and maintain strong supplier quality management systems.
Importance Supplier Quality Management in Pharma Manufacturing.
Pharmaceutical products are directly impacted by the quality of materials and services suppliers provide. Through the supplier quality management process, companies ensure that each supplier is helping meet quality and regulatory compliance goals — and is informed in a timely manner if performance is not up to standard. Poor supplier quality can have severe consequences, including product recalls, compromised patient safety, regulatory non-compliance, and damaged reputation. By proactively monitoring and evaluating supplier quality, pharmaceutical manufacturers can mitigate these risks and maintain the integrity of their products. Thus, a robust supplier quality management is essential for pharmaceutical manufacturers.
Key Elements of Effective Supplier Quality Management.
To establish an effective supplier quality program, several key elements need to be considered.
- Ensuring shared quality goals and expectations to foster a strong partnership.
- Using a risk-based approach to supplier management - selecting and qualifying suppliers based on their capabilities, quality systems, and regulatory compliance.
- Establishing clear quality requirements, specifications, and performance metrics for suppliers.
- Ongoing monitoring and evaluation through site audits, quality metrics, and risk assessments to ensure continuous improvement and adherence to regulatory and quality standards.
Implementing an effective supplier quality management system.
For effective supplier management, companies need to follow some basic steps in establishing and maintaining supplier relations:
1. Supplier selection: This step involves identifying and selecting the most appropriate suppliers for each type of product or service required by the company.
2. Evaluation the technical capacity: Before fully engaging a supplier, it is imperative to assess whether the supplier’s ability to supply the necessary materials and/or services that are of appropriate quality.
3. Document evaluation: This involves verification of documents as required by law and regulations, such as GMP and quality management system compliance, as well as other technical specifications.
4. Supplier audits: Carrying out periodic audits is necessary to ensure that suppliers comply with the required safety and quality standards.
5. Risk analysis: This involves the identification of risks associated with the supplier, such as questionable production practices or lack of quality control, among other situations that could affect the quality of the final product.
6. Supplier qualification: This consists of verifying that the selected suppliers meet the minimum requirements as required by the pharmaceutical industry regulations. for quality, sustainability, regulations and logistics.
7. Supplier Approval: After analysing all the aspects mentioned above, the company will then decide whether or not to approve the supplier to start their business partnership. If approved, the supplier joins the company’s list of qualified suppliers.
8. Contracting (Quality agreements): Contracting involves formalizing business arrangements with suppliers through clear, detailed contracts outlining conditions, rights, and obligations. Key components include scope, terms, prices, payment methods, guarantees, and penalties.
9. Verify the quality of inputs: This stage involves testing/verifying that products or the inputs and components supplied meet the pre-established specifications.
10. Continuous supplier monitoring: The process involves ongoing monitoring and control of the supplier's performance throughout the contract duration, ensuring adherence to the agreement and the delivery of quality products and services. Performance indicators, including rejected batches, supply turnaround times, and regulatory compliance, are used for effective assessment.
11. Supplier performance evaluation: this involves periodic comparison of results obtained by monitoring the supplier with the expected results. This assessment should generate constructive feedback for the supplier, recognizing its strengths and pointing out opportunities for improvement.
The use of an enterprise (electronic) quality management system provides a holistic way to manage the qualification, evaluation, and collaboration with suppliers, ensuring high-quality products and a robust supply chain. The suppler management module of the QMS enables maintenance supplier records, conducting audits, and facilitates effective communication with suppliers.
In conclusion, in the highly regulated world of the pharmaceutical manufacturing, supplier quality monitoring and evaluation play a vital role in ensuring the safety, efficacy, and compliance of products. By recognizing the critical role suppliers play in the production chain, manufacturers can proactively address potential risks, safeguard patient safety, and maintain regulatory compliance. Through the implementation of robust supplier quality management systems, which involve careful selection, ongoing monitoring, and collaboration, companies will ensure the production of high-quality pharmaceutical products.
