GAMP: The essential tool for maintaing 21 CFR Part 11 compliance

摘要

Since its enforcement, starting in 1997, Title 21 of the U.S. Code of Federal Regulations (CFR) Part 11 has had a resounding impact in the biotechnology and pharmaceutical industries. For cleanroom operators, in addition to validating all ventilation, monitoring, temperature and pressure systems, this means also ensuring compliance with 21 CFR Part 11 when data related to the manufacture of drugs and therapies is maintained electronically or submitted to the FDA electronically. In the strictest sense, 21 CFR Part 11 is applied to any pharmaceutical manufacturing process utilizing automated controls that generate data maintained in electronic format. The aim of this regulation is to ensure the authenticity and integrity of electronic records, and to prevent the signer from readily refuting the authenticity of his signature. In this article, we'll focus on small Commercial Off-The-Shelf (COTS) automated filter integrity test instruments used to test sterilizing and other process filters in cleanroom environments, and suggest how the latest version of the Good Automated Manufacturing Practices―GAMP 4, released in December 2001―can help ensure the accuracy and integrity of these systems.