Good Manufacturing Practice (GMP) is a system of mandatory regulations and guidelines designed to ensure that medicinal products, including drugs, biologics, and medical devices, are consistently produced and controlled according to quality standards appropriate for their intended use. It is a fundamental framework for the entire supply chain, from raw materials to the finished product. The primary goal of GMP is to minimize the risks inherent in pharmaceutical production that cannot be eliminated solely through testing the final product.
GMP covers all aspects of the manufacturing process, including the quality of raw materials, the maintenance and validation of facilities and equipment, staff training, and rigorous documentation of every step. Regulations enforce requirements such as having clear Standard Operating Procedures (SOPs), preventing cross-contamination, and ensuring product batches are traceable. Strict adherence to GMP is critical for all companies involved in the production of Active Pharmaceutical Ingredients (APIs) and finished dosage forms, as it provides regulatory bodies with confidence in the identity, strength, quality, and purity of the products on the market.
