GOOD MANUFACTURING PRACTICES (GMP)

Good Manufacturing Practices (GMP) are a set of guidelines and standards aimed at ensuring that products are consistently produced and controlled according to quality standards. GMP is particularly crucial in industries such as pharmaceuticals, food manufacturing, cosmetics, and dietary supplements. The primary goal of GMP is to safeguard the health and well-being of consumers by establishing a framework for quality assurance in the production process.

These guidelines are applicable to the manufacturing of medicinal products, including pharmaceuticals, biological products, and active pharmaceutical ingredients (APIs).

WHO GMP provides a set of internationally recognized standards for the manufacturing of pharmaceuticals. These standards are widely adopted by countries around the world to ensure the quality, safety, and efficacy of medicinal products.

Guidelines for the design, construction, and maintenance of premises and facilities to ensure a clean and suitable environment for pharmaceutical manufacturing. This includes considerations for preventing cross-contamination and ensuring proper sanitation. Procedures for quality control and testing throughout the manufacturing process, covering raw materials, in-process materials, and finished products. This includes sampling and testing based on established protocols.

Adherence to WHO GMP is critical for pharmaceutical manufacturers to produce safe and effective medicines that meet regulatory requirements. WHO GMP is not only relevant to manufacturers in developed countries but is also crucial for ensuring the quality of pharmaceuticals produced in developing countries. The guidelines contribute to global efforts to improve access to high-quality medicines and enhance public health worldwide.

GMP helps to ensure the consistent quality and safety of products by focusing attention on 5 P’s i.e. people, premises, processes, products and procedures.