Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.

Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

Incorporates good manufacturing processes into a compliant qualification programProvides examples of protocol layoutIncludes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

1. Introduction 2. Documentation - Getting Ready 3. Quality Systems 4. Equipment Design Considerations 5. Equipment Controls and Automation 6. Preparing the Protocols - General Approach 7. Commissioning & Decommissioning 8. Equipment Qualification Protocols 9. Equipment Checklist 10. Protocol Execution 11. Protocol Reports

Appendix A. Definitions B. Examples C. References