Manufacturing facilities for Penicillin - regulatory expectation

Cross-contamination is the contamination of one drug with one or more different drugs. Penicillin can be a sensitizing agent that triggers a hypersensitive exaggerated allergic immune response in some people hence it is required too put stringent controls in place to avoid cross contamination of other drugs  with penicillin

Following are few important comments from 21 CFR 211 which indicate FDA expectations.

21 CFR 211.42(d), mentions “ Operations relating to manufacture, processing and packing of penicillins shall be performed in facilitie separate from those used for other drug products for human use.”
However, FDA has clarified that separate buildings may not be necessary, provided that the section of the manufacturing facility dedicated to manufacturing penicillin is isolated (i.e., completely and comprehensively separated) from the areas of the facility in which non-penicillin products are manufactured.2

211.46(d) mentions “Air handling systems for manufacture, processing and packing of penicillin shall be completely separate from those for other drug products for human use.”

Additionally 211.176 mentions “If a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin drug product shall be tested for the presence of penicillin. Such drug product shall not be marketed if detectable levels are found when tested according to procedures specified in `Procedures for Detecting and Measuring Penicillin Contamination in Drugs.”

Accordingly, firms that manufacture penicillin  and other drug products should evaluate their manufacturing operations for the possibility of cross-contamination and implement appropriate controls to reduce or mitigate the potential for cross-contamination.

Such controls could include, but are not limited to, isolation and separation of facilities, equipment like Air handling units  and personnel.

At Source consulting we help our customers to respond to FDA observations. For any queries on  Penicillin cross contamination, FDA expectations on Penicillin facilities, compliance to regulatory inspection for cross contamination related observations Source consulting team of highly experienced pharma professionals is  always available to help our clients.

For more details you may contact Sourceconsulting team.

01 Jan 2018