عملیات سیستم کنترل آزمایشگاهی در محیط GMP

عنوان فارسی:      عملیات سیستم کنترل آزمایشگاهی در محیط GMP

عنوان انگلیسی:      Laboratory Control System Operations in a GMP Environment

In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System.

Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices.  Additionally, a chapter outlining Stability Program operations is included in the text.

In addition to these topics, it includes LCS information and tools such as:

• End of chapter templates, checklists, and LCS guidance to help you follow the required standards
• Electronic versions of each tool so users can use them outside of the text
• An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems

For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

1. Introduction to the Quality Systems Based Approach to CGMP Compliance
2. Components of the Laboratory Managerial and Administrative Systems Sub Element (MS)
3. Components of the Laboratory Documentation Practices and Standard Operating Procedures Sub Element (OP)
4. Components of the Laboratory Equipment Sub Element (LE)
5. Components of the Laboratory Facilities Sub Element (LF)
6. Components of the Method Validation and Method Transfer Sub Element (MV)
7. Components of the Laboratory Computer Systems Sub Element (LC)
8. Components of the Laboratory Investigations Sub Element (LI)
9. Components of the Laboratory Data Governance and Data Integrity Sub Element (DI)
10. Components of the Stability Program Sub Element (SB)
11. Components of the General Laboratory Compliance Practices Sub Element (CP)
12. Summary for Establishing and Maintaining a Laboratory Control System