ABSTRACT

This book discusses managing SOPs for 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 focused on the practical aspects of SOPs and SOP management.

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