GMPs provide for documented evidence that a manufacturer maintains a level of quality by design and quality systems to ensure product quality, strength, purity, and identity. GMPs require specifications to be established for raw materials, packaging materials, labeling and finished products. These specifications must address quality issues as well as potential adulteration and contamination issues. GMPs require procedures for the review, approval and release or rejection of raw materials, packaging materials, labeling and finished products based on conformity to established specifications. Additionally, GMPs provide for a mechanism for investigation of deviations, deficiencies and/or failures to determine root cause(s) and to implement corrective and preventative actions as necessary. GMPs ensure that companies promote a culture of ‘continuous improvement’.
