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Friday, October 14, 2011

Current Good manufacturing practices regulations for manufacturing of penicillin and betalactum antibiotics.

Current good manufacturing practices requirements for manufacturing of penicillin and betalactum antibiotics and non penicillin betalactum antibiotics.


Both penicillin and other non penicillin beta lactum antibiotic are capable of producing severe lifethretehning anaphylactic reactions and shock .

A non betalactum antibiotic can sensitize an individual for other non betalactum antibiotic and can produce cross reactivity which can be equally serious.

Also read here 
Why beta lactum and penicillin produce allergic and anaphylactic reaction
Chemistry and mode of these reactions.


Current Good Manufacturing Practices and Regulatory requirements for manufacturing of penicillin and non penicillin betalactum antibiotics


Controlling of cross contamination:
21 CFR 211.42 Subpart (c) : States Requirements about building and facility for control and its required for manufacturing or even repacking of drug containing penicillin for manufacturing process, packaging and holding. Penicillin production process, handling storage or repackaging or holding must be done in an aria of adequate size and which is defined or assigned only for penicillin.
The facility must be such that it controls as well as prevent cross contamination to other product, while process like, receipt, issuing, storage holding or rejection packaging or labeling or before sampling, while in quarantine, before or after release, during sampling or testing by QC.

Prevention for contamination in other products with dedicated facility:
21 CFR 211.42 Subpart (D), Says that all operations for manufacturing and packaging or repackaging of penicillin antibiotics must be done in a facility separate from other facilities which are used for manufacturing of non penicillin and non betalactum drugs.

However FDA says that it is not necessary to provide a complete separate building, but the aria where manufacturing packing and filling and processing of penicillin happens must be strictly and completely isolated from the rest of arias completely so as to control and prevent cross contamination of other drug products, it can be with providing separate air handling systems, and other dedicated ancillary systems and arias.

Testing of drugs for traces of penicillin and betalactum cross contamination:


21 Cfr 211.176 regulation:
US FDA has provided process for detection of cross contaminations of penicillin in other drug products which are incorporated with reference.

21 Cfr 211.176 requires that drug manufacturer must test all drugs being manufactured in facility for traces of penicillin with the procedures provided and if the traces are found to detectable level with the process of detection those products must not be sent to market.

There is no separate or specific good manufacturing practice guidelines for API (penicillin) or non penicillin betalactum antibiotics, manufacturing , processing , or repacking or holding rather FDA’S Good manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH Q7 guidance) are required to meet these guidelines are more or less similar to drug products containing penicillin. which require a separate production aria , which completely isolated so as to avoid cross contamination to other product , and be provided with separate dedicated equipment and air handling systems.

As betalactum ring has property to produce a anaphylactic reactions , similar to penicillin , the good manufacturing practices regulations for penicillin also applies to all antibiotics containing beta lactum ring and antibiotics having similar property to sensitivity as beta-lactum though it may not contain exact close ring of beta lactum a open ring similar to beta lactum too is required to comply with good manufacturing practices regulations for penicillin and beta lactum .

Also there is observed that sensitization with traces of one beta lactum antibiotic may produce sever anaphylactic reactions when encountered with other beta lactum or penicillin antibiotics (cross reactivity).

Following are the classes of beta lactum antibiotics
Penicillins (oxacillin, ampicillin)
Cephalosporins(cefaclor, cephalexin)
Penems(meropenem, imipenem)
Carbacephems (loracarbef)
Monobactams(aztreonam).
These class of antibiotics are required to be manufactured in a separate and completely isolated manufacturing place or a facility with dedicated equipment , air handling systems and units.

Type of cross contamination must be avoided:

FDA recommends that manufacturer must ensure that following types of cross contamination do not occur

1.Non penicillin beta lactum to Non penicillin non betalactum drug
2.Non penicillin beta lactum to other non penicillin betalactum
3.Penem and Carbapenems  to other non penicillin betalactum
4.Cephalosporins to other non penicillin non betalactum non penam carbapenam antibiotics drugs 
Many sterile drug manufacturing facilities adapt separate area for one type of antibiotic mentioned above.


Therefore arias where penicillin betalactum antibiotics are manufactured must be completely separated and isolated with dedicated and isolated equipment and aria.



Also see

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Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures

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