Penicillin was discovered by Alexander Fleming in 1928. Since then penicillin was used widely to cure the people from bacterial infections by inhibiting their cell wall synthesis. Beta-lactam ring of penicillin is responsible for its antimicrobial activity. There are a lot of other antibiotics those also contain beta-lactam ring.
Beta-lactam antibiotics include Penicillins (ampicillin, oxacillin), Cephalosporins (cephalexin, cefaclor), Penems (imipenem, meropenem), Carbacephems (loracarbef) and Monobactams (aztreonam).
Penicillin is found to be an allergic drug, showing the harmful effect on human health. Penicillin may cause life-threatening allergic reactions. Due to penicillin allergy fever and asthma may occur because immunoglobulin E (IgE) shows hypersensitivity to the penicillin molecule in allergic people.
A skin test is done to determine that penicillin is allergic to the person or not. About ninety percent people are not having a penicillin allergy. A full oral dose of penicillin is given after passing the skin test to confirm that penicillin is not allergic to the person. People having a history of penicillin allergy may have an allergic reaction to Cephalosporins.
According to FDA current good manufacturing practice cross-contamination between beta-lactam and non-beta lactam products should be avoided and cross-contamination between penicillin beta-lactam and non-penicillin beta-lactam should also be avoided.
There should be separate manufacturing facility for penicillin beta-lactam and non-penicillin beta-lactam products. Separate manufacturing facility means separate building, air handling unit, equipment, all utility except electricity and even staff. Cross-contamination should be fully avoided even by means of air. So there should be a proper distance between two manufacturing facilities. For non-penicillin beta-lactam products e.g. cephalosporin, it is not necessary to have a separate manufacturing facility.
US food and drug administration also recommend having separate manufacturing for beta-lactam and non-beta lactam API and finished products. All these manufacturing facilities must also have separate air handling system and HVAC system. FDA also says that only drugs of cephalosporin family are not required to be manufactured in separate facility and air handling system and can be manufactured in same equipment after proper cleaning. Validation of equipment cleaning procedure should be done.
cGMP regulations require that if there is any possibility of contamination of penicillin in non-penicillin products, the non-penicillin product must be tested for the presence of penicillin and product must not be marketed if there is evidence of its presence at a detectable level.
Its very beneficial to all concerned...
ReplyDeleteOkay
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ReplyDeletewhat is the distance between Beta and Non-Beta facilities as per Regulatory standards?
ReplyDeleteHello.... plz i have just wanted to ask a question .....Do synthesis of Non-Pencillin beta lactam groups need to be separated from each other?? for example can synthesis of Meropenem antibiotic occur in the same facility of cephalosporin ? Thank u so much
ReplyDeleteWhat about QC labs for both products ??must they be separate labs??
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