penicillin and dedicated facility
Contribution from ok written on 7/9/2009 at 06:33
3.6 In order to minimise the risk of a serious medical hazard due to cross-contamination, dedicated and self contained facilities must be available for the production of particular medicinal products, such as highly sensitising materials (e.g. penicillins) or biological preparations (e.g. from live micro-organisms). The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and non-medicinal products should not be conducted in the same facilities. For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.
Regarding dedicated facility or dedicated equipment, I think the above text is wrong.
For penicillins derive from fermentation process, the dedicated facilities or dedicated equipment should be used to deal with these specific materials.
For penicillins derive from synthesis process, the dedicated facilities or dedicated equipment need not be used.
I ever see one concept paper issued by EMEA about the topic, do you have new information about it?
I hope QBD concept to be used in GMP guidance revision.
Answers to this contribution:
Answering this Contribution: