The purpose of this guide is to provide tools that enable suppliers and service providers of the Healthcare and Pharmaceutical Industry to carry out robust investigations of nonconformities that help determine the impact on the quality of the product involved and consequently, the potential adverse impact for the patient that uses that regulated product. This publication is available in three languages.

This whitepaper provides an overview of industry best practices for developing and implementing an effective conveyance
security program regardless of company size or prior experience with supply chain security issues.

Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously completing […]

The manufacture of medical products, drugs and devices is highly regulated all over the world. All aspects of the manufacturing process, from product design to product delivery, require documented procedures. Key points in the process […]

Medical products are items used to diagnose, treat, cure, mitigate or prevent disease in patients. These include pharmaceutical products and medical devices. The manufacture of medical products that are used in the United States, and […]

The warehousing and distribution of regulated medical products is a very important part of the supply chain from manufacturer to the patient. Various separate entities are responsible for the storage and shipping of these products […]

This Best Practices Quality Agreement Guide is intended to assist both Customers and Suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements. “Supplier” is used broadly in this document to […]

Materials derived from human blood such as human serum albumin and transferrin are frequently used either as components of cell culture medium or in other processes. Suppliers of such reagents have incorporated multiple mitigation steps such as sourcing pharmaceutical grade or licensed drug product, sourcing from safe geographical regions, testing for contaminants and inactivation. In addition, this information needs to be available for review during inspections and in regulatory filings. This questionnaire is a comprehensive list of those requirements and will be a useful document for reference.