We enter this world as “clean slate”, and we need help and support before we stand alone or set our journey. Pigeons teach their young ones how to fly and return back to their place till the young ones learn how to fly and see the outside world. When we visit a new place to […]
We had heard Doctors saying “Operation success but patient died”. There are many reasons for this statement, the treatment / surgery might have been late, the age, immune system did not respond, drug not effective etc. This statement might have been more relevant to the failure rate of surgeries due to the operation theatre conditions. […]
50 years back, there was a major incident involving the manufacture of a pharmaceutical product [ 5% Dextrose, Intra Venous infusion] in Devonport near Plymouth, England. The event is remembered as “Devonport disaster”. Given the time, many working in the pharmaceutical industry have never heard about the disaster. Many died after the administration of 5% […]
Overview 1.Fish bone diagram is a tool which is used to identify the root cause of the problem. The fish bone diagram is also called as Ishikawa diagram based on its pioneer Kaoru Ishikawa, a Japanese Engineering professor. He is noted for his quality management innovations and considered a key figure in the development of quality initiatives […]
Concept 1.The drug injections/infusions that are manufactured in the pharmaceuticals are tested for sterility for every lot/batch. Sterility testing is performed to check the drug injections/infusions that are released to the market as “STERILE” i.e., they are free from microorganisms. Any drug injections/infusions that reach the blood system should be sterile or else the contaminated […]
Rabbits were used for the pyrogen testing from 1940’s and were replaced with LAL testing from 1977. For LAL testing [Bacterial endotoxins], the blood of horse shoe crabs are used to till date. LAL testing continues to serve as an efficient and reliable safety test for human and animal injectable drugs. LAL test prevails in the pharmaceutical […]
What are residual solvents in a drug? Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. The solvents are not completely removed by the manufacturing techniques. The content of solvents in such products should be evaluated and justified. Appropriate selection of […]
Like the holy books in every religion, the ALCOA principles should be the holy books in all pharmaceutical and medical device manufacturing facilities all over the world. All the data, the research work, clinical trial data, validation / qualification data, manufacturing batch record, monitoring records etc. are equally important and they form the foundation of […]