Main description:

Because the FDA's cGMPs are only guidelines, each company is on their own to design their Standard Operating Procedures (SOP) system. The vast literature pertaining to SOPs provides general instructions, but no article or book explains exactly how to develop and manage them until now. "How to Develop and Manage Standard Operating Procedures" describes the necessity of SOPs, explains how to develop and use SOPs, and details how to manage SOP documentation. The book also provides insight into how the SOPs relate to each other and to the overall documentation system. Readers will understand which SOPs need to be written, how many SOPs are enough, how to assign identification numbers, how to manage SOP changes, and how to create an SOP history file. Finally, they will be able to show that the SOPs are released and ready for use.

Contents:

Introduction. SOP Master Lists. SOP Format and Style Guide. SOP Writing through Approval. SOP Change Control. Document Control. Electronic SOP Documentation Databases. Appendices.