Engaged. Knowledge. Application
Supplier Qualification Programs: Establishment and Implementation
This GXP Instructional Guide will review requirements for establishing and implementing a Supplier Qualification program based on Good Manufacturing Practice (GMP) requirements.
Introduction to Supplier Qualification
➢ Basic Overview
➢ Customer Teams
➢ Supplier Selections
➢ Initial Supplier Contacts
➢ Process Elements
➢ Customer Inspection
➢ Supplier Reporting
➢ Decertification
GMP Regulations that Pertain to a Supplier Qualification Program
➢ Current Good Manufacturing Practice (cGMP) Regulations at a Glance: An In-depth Review
➢ Part 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
➢ Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals
➢ 21 CFR 211 Subpart E: Control of Components and Drug Product Containers and Closures
Establishing a Supplier Qualification Program
➢ Getting Started
➢ Supplier Classification Scheme
➢ Decertification
➢ Supplier Qualification Program Design Principles—Taking a Closer Look
Meeting Quality Requirements
➢ Defining Excipient cGMP Standards—An Evolving Environment
➢ Active Pharmaceutical Ingredient (API) Quality Standards
➢ Supplier Quality Assessments
➢ Interaction between the Quality Assurance, Purchasing, Quality Control and Production
➢ Utilizing Quality Agreements
➢ Managing Change
Includes over 20 Industry Definitions and References
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