ABSTRACT

Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focus

chapter 1|6 pages

Introduction to SOPs

chapter 2|16 pages

Document hierarchies

chapter 3|6 pages

When to have an SOP

chapter 4|8 pages

What the SOP should say

chapter 5|10 pages

Where to put the output

chapter 6|4 pages

Who writes SOPs?

chapter 7|8 pages

Document a stable process

chapter 8|10 pages

Mapping a new process

chapter 9|20 pages

The SOP template

chapter 10|14 pages

SOP review and approval

chapter 11|12 pages

Posting: Setting up for success

chapter 12|10 pages

Deviations from controlled procedures

chapter 13|16 pages

Active SOP maintenance

chapter 14|6 pages

Finding SOPs

chapter 15|12 pages

Training on SOPs

chapter 16|12 pages

Department-managed documents

chapter 17|6 pages

Where to start

chapter 18|6 pages

SOPs during mergers and acquisitions

chapter 19|6 pages

Controlled glossaries