SOP Guidelines

It covers the following fields:

Production
Quality Control
Quality Assurance
Stores
Engineering
Maintenance
Housekeeping

Today, one of the basic tenets of cGMP is the assumption that if it is not written, it is not done. Therefore, in order to make sure that a particular operation has been performed , appropriate Standard Operating Procedures is designed. This document not only specifies the exact procedure to be adopted for a particular operation but also specifies the persons who check and approve the procedure. Over 3 decades of hands-on production experience of D.H. Shah, a qualified pharmacist, is distilled in this unique book published for the first time ever giving actual SOPs covering all facets of pharma production.

The 370 SOPs included in the book are distributed among the following categories:

Tablets & Capsules - 97 Nos.
Ointments - 18 Nos.
Quality Control - 77 Nos.
Liquid Orals - 25 Nos.
Sterile Preparations - 133 Nos.
General - 19 Nos.

Plus SOP for Standard Operating Procedures