The result of eye drops being contaminated with Pseudomonas aeruginosa can be a considerable loss of vision or even complete blindness, as happened to some users in Sweden in 1968. Infectious pathogens – bacteria, viruses, fungi, parasites – that find their way into the blood stream can multiply and cause blood poisoning, called sepsis, a severe immune response to pathogens or their toxins.
Minimising microbial contamination during the production of pharmaceuticals is an absolute necessity
Minimising microbial contamination during the production of pharmaceuticals is an absolute necessity. The GMP Guidelines therefore impose a steadily growing number of requirements that oblige manufacturers to guarantee drug safety by following appropriate quality assurance and quality management concepts. These GMP Guidelines deal not only with the pharmaceuticals themselves, i.e. with their production, packaging and testing, but also with the supply of all starting materials, including any machinery and equipment required. Personnel hygiene and personnel training are also core fundamentals covered by GMP Guidelines.
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