Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-penicillin Products : Pharmaceutical Guidelines

Separate Manufacturing Facility is Required for Manufacturing of Penicillin and Non-penicillin Products

Learn why separate manufacturing facilities are required for manufacturing of penicillin and non-penicillin drug products.
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
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.






Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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