Equipment Qualification in the Pharmaceutical Industry (Aspects of Pharmaceutical Manufacturing)

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 program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements Front Matter......Page 1 Copyright......Page 3 Dedication......Page 4 Acknowledgments......Page 5 Introduction to aspects in pharmaceutical manufacturing......Page 6 Introduction......Page 7 Qualification......Page 8 Validate/validation......Page 9 The order of the qualification process......Page 11 Overview......Page 13 Documentation......Page 15 Drawings......Page 18 SOPs......Page 19 Summary......Page 20 Quality systems......Page 21 Quality risk management......Page 22 Change control......Page 24 Investigations......Page 25 Corrective action-Preventive action......Page 26 Preventive maintenance......Page 27 Document control......Page 28 Re-qualification......Page 29 Equipment design considerations......Page 30 Materials of construction......Page 34 Cleaning and maintenance......Page 35 Other considerations......Page 37 Equipment controls and automation......Page 39 Structural qualification......Page 40 Functional qualification......Page 41 IQ/OQ for computer or automated systems......Page 42 Summary......Page 45 Protocol development......Page 47 Layout......Page 51 Stand-alone conditions......Page 52 Protocol review......Page 53 FAT and SAT......Page 55 Commissioning......Page 57 Decommissioning......Page 60 Equipment qualification protocols......Page 63 Product contact......Page 64 Safety......Page 65 Environmental conditions......Page 66 Installation qualification......Page 68 Operational qualification......Page 70 Performance qualification......Page 72 Protocol review......Page 73 Equipment checklists......Page 74 Protocol execution......Page 84 Good documentation practices......Page 85 Test instruments......Page 87 First steps......Page 88 Second steps......Page 89 Handling deviations in the protocol......Page 90 Summary of protocol execution......Page 92 Preparing the report......Page 93 Conclusions......Page 95 Deviations log......Page 96 Appendix A: Definitions and abbreviations......Page 98 Appendix B......Page 106 Appendix C: References......Page 215 E......Page 217 O......Page 218 Q......Page 219 W......Page 220 Equipment Qualification In The Pharmaceutical Industry Provides Guidance That Needs To Be Included In Quality Qualification Programs. The Book Outlines Guidelines For The Preparation And Execution Of Qualification Protocols, Including Installation (iq), Operational (oq), And Performance (pq) Factors. In Addition, It Discusses The Importance Of Related Qualification Programs (e.g., Computer System And Cleaning) And How To Incorporate Them Into A Fully Compliant Qualification Program. Further, It Provides Matrices Of What Could Be Included For Major Types Of Process Equipment. While Primarily For People Entering The Pharmaceutical Industry, Those Established In The Field Will Benefit From The Examples, Matrices, And Integration Of Related Systems.