How GMP changed with time

Good manufacturing practices emerging trends

GMP History dates back to 1900 and is associated with well known tragedies and actions taken to prevent them from occurring in future.

• In 1906 Pure food and drug act bill was passed by government to establish FDA(Food and drug administration) as a result of peoples response to well known Jungle book which outlined the immense Unhygienic practices followed by food and drug product manufacturers and this act also made selling of Misbranded and Mislabeled drugs illegal.
• In 1938 Food drug and cosmetic act the bill is passed by congress in response to Sulphonamide tragedy which led to 107 deaths act made manufacturers of drugs compulsory to show safety of drugs manufactured.
• In 1941 Sulpahthiazole contaminated with Phenobarbital caused nearly 300 deaths Result is FDA revised Manufacturing and quality controls drastically it was an beginning of what today is called GMP
• In 1962 Kefauver-Harris drug amendments is associated with Thalidomide tragedy which resulted in birth defects in thousands of European babies Result is Manufacturers must prove efficacy of drugs prior to marketing.
• In 1978 cGMP 21 CFR 210 and 211 final guidelines for minimum regulatory requirements for Manufacturing, Holding, Packing and distribution of Medicines and Medical devices.
• In 1979 GLP final rule 21 CFR 58 for establishing good laboratory practices for Non clinical laboratory studies.
• In 1982 GMP is revised for Tamper resistant packaging act came due to tragedy in which 7 people was killed due to Acetaminophen capsules poisoning by Cyanide.
• In 1983 Guidelines for validation of computer systems came to put tighter stringents on computer systems.
• In 1987 Guidelines on Principles of process validation came to provide consistency in drug quality.
• In 1992 Generic drug enforcement act is introduced to curb down illegal activities like bribing for approval of ANDA(Abbreviated new drug application).
• In 1998 Draft on guidance was introduced to lay down procedure for manufacturing , processing , packing, Investigating OOS(Out of specification) and OOT(Out of trend) in pharmaceuticals.