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Posted 17 April 2013 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has just published a new guidance document that finalizes its manufacturing framework for the production of many antibiotics.
FDA closely regulates the manufacture of drug products through a series of regulations known as current good manufacturing practice (CGMP) regulations. Those regulations reflect a wide array of requirements that manufacturers are supposed to follow in their facilities, including record-keeping, cleanliness, staffing, change controls and standards of sterility.
But while those standards are largely similar, they also depend on the particular product being produced. A sterile drug that is injected into a patient, for example, will be required to meet much higher standards of sterility than a non-sterile oral tablet drug might.
To assist manufacturers with the unique CGMP requirements of various products, FDA often puts out guidance documents meant to outline what the agency sees as recommended and acceptable practices.
FDA's latest, Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination, is aimed at non-penicillin drugs characterized by a beta-lactam ring, a chemical structure common to many types of antibiotics including caphalosporins, monobactams, penems, carbapenems and penicillin.
One of the main problems associated with the manufacture of these drugs is their propensity to cross-contaminate one another if not properly separated. While problematic for its own sake, the contamination can create additional problems as well at the user level if not properly controlled, FDA explained. That's because some people are hypersensitive to penicillin and can have an "exaggerated allergic immune response" if exposed to the drug, potentially resulting in death.
As a result, manufacturers need to take extreme care to make sure that the manufacture of penicillin takes place in entirely separate facilities, FDA recommended.