GMP Quality Policies

One of the first steps for any company to start to gain compliance to the FDA Final Rule of Electronic Records and Electronic Signatures (21 CFR Part 11) is to have a documented interpretation of the rule.  Once the interpretation is set for the company, policies and procedures can be written according to that guidance. This document provides a solid interpretation of 21 CFR Part 11 that allows for flexibility in designing systems around it.  This document is also easily edited to your specific business requirements.

Guidance document on the manufacturing of biological APIs for use in pre-clinical toxicology studies and pivotal clinical trials.

Policy on company-wide documentation practices.

Policy on pest control for GMP and quality-controlled firms.

Policy on significant figures and rounding. Ensures that everyone in the company is following the same standards.

Policy on how to document things in laboratory notebooks.

Guidance for keeping audit reports confidential to your firm.