Risk-Based Supplier Qualification: Finding the Right Vendors for the Most Critical Supplies
Effective supplier qualification, evaluation and monitoring are critical to a successful risk-based quality management approach — and an ineffective system can result in costly and dangerous consequences for the manufacturing and distribution process. To ensure regulatory compliance and manufacture quality pharmaceutical products, there’s no room for any inadequate or inconsistent assessments of suppliers.
But how can you ensure these sources and contractors, who are often spread across the globe, are limiting risk and complying with relevant standards?
Using the Risk-Based Supplier Qualification management report, you will be able to develop a detailed plan for evaluating and addressing risk when working with suppliers. You’ll gain a deep understanding of the supply-chain elements that impact risk management and the regulatory requirements around suppliers, allowing your team to focus on safely manufacturing the most effective pharmaceutical products.
International quality management expert Christian Gausepohl discusses the life cycle of a supplier relationship, how to determine excipient risks and ways to develop a supplier quality agreement. He shares how you can better identify manufacturing risks and provides key considerations necessary for evaluating suppliers. Through his industry experience, you’ll find the tools to conduct third-party audits and mitigate the inherent risks of contracting with a supplier.
- Key considerations in evaluating suppliers
- Understanding the source and complexity of the supply chain
- The risk analysis needed for evaluating supply errors
- Estimating the probability of risks and their likely discoverability
- The difference between intermediaries and manufacturers
- Stages of risk assessment
- The life cycle of a supplier relationship
- How and when to conduct periodic supplier reviews
- Regulatory requirements for controlling suppliers
- Determining when to conduct a third-party audit
- Rules for importing starting materials
- Special considerations for evaluation
- Evaluating active pharmaceutical ingredient (API) and excipient suppliers
- Deciding how to handle atypical APIs
- Developing a supplier quality agreement
Not only does this report cover critical details on creating an effective and useful strategy for addressing supplier risks, it also contains a 20-page risk-analysis worksheet on evaluating the impact and severity of supply errors. These tools and insights will provide you and your team everything you need to successfully bring your safe, compliant product to market.
Don’t miss this unique chance to learn from an industry expert and create a successful plan for assessing and managing supplier risk.
About the Author
Christian Gausepohl is a pharmacist and head of quality assurance at Rottendorf Pharma, where he is also a qualified person. His expertise includes coordinating technology transfers, process optimization and validation plans. He is also experienced in conducting audits for regulatory authorities, drugmakers and suppliers.
Who Will Benefit
- API and excipient manufacturers
- Packagers and distributors
- Quality management staff
- Purchasing staff
- Legal staff
- Regulatory staff
- Inspections and audit staff
Add to Cart
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Books Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.