hello,
looking for your help.
why steroid and non steroid cannot be manufactured in same line.
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There are no FDA/EMA/WHO guidelines prohibiting the manufacture of steroid & non-steroid products utilizing the same manufacturing facility, line, or equipment. The only products prohibited from manufacture within the same facility are penicillin products by 21 CFR 211.42(d).
WHO document, âQuality assurance of pharmaceuticalsâ 2nd edition dated 2006 provides some additional guidelines & information as well as EU Guidelines to GMP Annex 1 for Sterile Medicinal Products.
thank you so much for your valuable info.
manufacture of steroid & non-steroid products utilizing the same manufacturing facility, line, or equipment. The only products prohibited from manufacture within the same facility
- FDA and EU required dedicated facilities for beta-lactam antibiotics when manipulating pathogenic live organisms.
- For the rest of products the segregation and dedicated facilities should be required when the physical and procedural controls cannot demonstrate the capacity to keep under acceptable control limit the risk of cross-contamination
- Objective criterion to define the risk of cross-contamination utilizing the ARL (acceptable residue level).
- Calculation of ARL and cleanliness limits are based on the toxicological information of the involved products, this toxicological information must be supported scientifically by a toxicological expert and if possible also by a doctor skilled in medicinal products evaluation.
- The cleanliness information along with the corresponding risk analysis is the rational one for the introduction of new products to the manufacturing areas.
This is in continuation of my previous communication about the dedication of the manufacturing facilities for steroid and non-steroid type of drug products. Here is a table showing the details about the same.
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