Children who received antitoxin for diphtheria treatment died of tetanus because the horse serum that had been used to prepare the antitoxin was contaminated with tetanus
The wrong raw material and an elixir of sulfanilamide, anti-infective drug used in 1935. One company used diethylene glycol, a poisonous solvent and chemical analog of antifreeze, in an oral "elixir of sulfanilamide." Before the problem was discovered, 107 people died, many of them children
Congress passed the Federal Food, Drug and Cosmetic (FD&C) Act. For the first time, companies were required to prove that their products were safe before marketing them
Thalidomide was marketed in Europe as a sleeping pill and to treat morning sickness. When regulatory agencies gave permission to sell the drug for that indication, they had no knowledge of its serious side effects. It turned out to be teratogenic, It caused serious deformities in developing fetuses
Children whose mothers took thalidomide in the first trimester were born with severely deformed arms and legs. An estimated 10,000 cases of infant deformities in Europe were linked to thalidomide use
The 1972 Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients developed infections. An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose IV solutions that were not uniformly sterile
GMPs for drugs (21 CFR Parts 210 and 211) and medical devices (21 CFR 820) were made final. They were intended to help ensure the safety and efficacy of all products
12-year-old Mary Keller man died after taking an extra-strength Tylenol acetaminophen capsule, Six other people died after taking the same drug. Johnson & Johnson announced a nationwide recall of 31 million bottles of Tylenol. The investigation revealed that a criminal tamper had opened up and laced some capsules with cyanide
An outbreak of toxic reactions to over-the-counter tryptophan, a dietary supplement, resulted in 38 deaths and probably thousands of less severe reactions. The event was the result of a manufacturing process change that increased the level of a harmful byproduct. Doses that had previously been safe now caused toxicity
The Regulatory Authorities all over the world have accepted that a pharmaceutical product which meets the following five characteristics can be expected as a quality product: Identity, Strength, Safety, Purity, Efficacy
A legal and official book issued by recognized authorities usually appointed by Government of each country, comprising list of pharmaceutical substances, formulae along with their description and standards
Given in Six Volumes: Volume I & II contains medicinal substances, Volume III contains formulated preparations, blood related products, immunological products, radiopharmaceutical preparations, surgical materials & homoeopathic preparations, Volume IV contains supplementary chapters, IR spectra etc., Volume V contains veterinary, Volume VI contains CD ROM version
European pharmacopeia commission started working since 1964
1st edition published in 1967, 2nd edition in 1980, 3rd edition in 1997, 4th edition in 2001, 5th edition in 2004, 6th edition in 2007, 7th edition in 2010, 8th edition in 2013
1. Gather information on the substance: origin, whether mixture or single entity, method of preparation, different crystalline forms, enantiomers, hydrates, different entities (acid, base, salt, etc)
2. Consult existing monographs on similar substances
3. Use the International Nonproprietary Name (INN) established by the World Health Organization in the title
4. Ascertain the chemical structure precisely to establish the exact graphic formula, empirical formula, relative molecular mass, chemical name
5. Specify the content and assay limits
6. Describe the appearance, solubility, stability factors, hygroscopicity, solid-state properties, other characteristics, behavior in solution
Appearance of solution: to ascertain the general purity of a substance by the detection of impurities insoluble in the solvent or of coloured impurities