Good Manufacturing Practices
Question1. What is meant by GMP? Give a brief account on historical background of GMP.
Answer: GMP is defined as Good Manufacturing Practices are practices and the system requirements to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals of drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices. GMP guidelines are not prescriptive instructions on how to manufacture products but are a series of general principles that must be observed during manufacturing.GMP was first introduced in the food industry during mid-1800’s and was mostly responsible of local and state regulators. However, the pure food and drugs act passed by Congress in 1906 marked the first major federal consumer protection law with respect to food processing. The law prevented interstate and foreign commerce in misbranded and adulterated foods, drinks or drugs. The intent of the Act was to prevent poisoning and consumer fraud. However poor quality food products and deceptive packaging continued to be produced due to loopholes in the law. Consumers were often unaware of what they were buying until products were opened. Therefore, in 1933 the FDA decided to overhaul the 1906 act. In 1938, after a battle about USDA jurisdictions with respect to the Act’s enforcement the Food drug and Cosmetic Act (FDCA) replaced the 1906 Act. The FDCA provided the necessary identity and quality standards to protect consumers from fraud and also laid the regulatory basis for today’s food GMP’S.
Two sections of the FDCA are directly related to conditions in a facility where food has been manufactured.
-Section 402(a) (3) specifies that food has been manufactured under such conditions that is unfit for consumption
-Section 402(a) (4) considers that food may be adulterated if it is prepared ,packed or held under unsanitary conditions whereby it may become contaminated with filth
Answer: GMP is defined as Good Manufacturing Practices are practices and the system requirements to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals of drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices. GMP guidelines are not prescriptive instructions on how to manufacture products but are a series of general principles that must be observed during manufacturing.GMP was first introduced in the food industry during mid-1800’s and was mostly responsible of local and state regulators. However, the pure food and drugs act passed by Congress in 1906 marked the first major federal consumer protection law with respect to food processing. The law prevented interstate and foreign commerce in misbranded and adulterated foods, drinks or drugs. The intent of the Act was to prevent poisoning and consumer fraud. However poor quality food products and deceptive packaging continued to be produced due to loopholes in the law. Consumers were often unaware of what they were buying until products were opened. Therefore, in 1933 the FDA decided to overhaul the 1906 act. In 1938, after a battle about USDA jurisdictions with respect to the Act’s enforcement the Food drug and Cosmetic Act (FDCA) replaced the 1906 Act. The FDCA provided the necessary identity and quality standards to protect consumers from fraud and also laid the regulatory basis for today’s food GMP’S.
Two sections of the FDCA are directly related to conditions in a facility where food has been manufactured.
-Section 402(a) (3) specifies that food has been manufactured under such conditions that is unfit for consumption
-Section 402(a) (4) considers that food may be adulterated if it is prepared ,packed or held under unsanitary conditions whereby it may become contaminated with filth