GMP Evaluation on Sage Pharmaceuticals' Factory
The Ministry of Health and Welfare, the New Taipei City Health Commissioner and committee experts visited SAGE to ensure the compliance of practices. We also exchanged experiences and opinions on issues such as GMP quality control, production facilities, and risk management.
What is GMP?
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice.
SAGE factory is in compliance with GMP (Good Manufacturing Practice) standards, ISO 22716. We strictly control every manufacturing process with high standards to provide customers high quality, highly effective, highly stable, high permeability, and safe-to-use products.