Approach
Current Good Manufacturing Practice (cGMP) is the accepted global standard within the world of pharmaceutical manufacturing. The FDA, in its published initiative “Pharmaceutical cGMPs for the 21st Century” describes a risk-based approach to the development and manufacture of human and veterinary drugs. They call for an early adoption of new technological advances, particularly as they are applied to the facilitation of modern quality management techniques. They want to ensure that regulatory review, compliance and inspection policies are based upon state-of-the-art pharmaceutical science. This means that many companies will need to review their quality SOPs to align with best practice.
In this ever-changing environment SOLABS endeavours to be at the forefront of best current practices. This is not an environment for generic compliance systems but for knowledge-based implementation and maintenance. SOLABS shares the goals of the FDA and other global regulatory bodies in protecting the integrity of public health as well as the patient-centric philosophies of world-class pharmaceutical suppliers.