Is dedicated facilities required for hormones – medicinal products and APIs
Is there a regulatory requirement for dedicated facility for sex hormones / female sex hormones medicinal products and APIs. Can we manufacture non sex hormones, general products in same facility.
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Regulatory guidance’s do not categorically ask for dedicated facilities for hormone products. ICH Q7A (Section 4.40 Containmant) recommend to consider dedicated production areas for materials with high pharmacological activity (which include certain steroids) or toxicity involved. The Q7A also asks for validated inactivation and /or cleaning procedures. The EMA document Q&A on implementation of risk based prevention of cross contamination and setting health based exposure limits (HBEL) recommends dedicated facilities where control measures cannot adequately assure that the potential contamination is consistently controlled to a level below that of the HBEL. The WHO guidance Annex 3 Good manufacturing practices for pharmaceutical products containing hazardous substances require products containing hazardous materials should “generally” be conducted in separate, dedicated facilities. It goes on to suggest physical barrier between blocks, separate entrances, staff facilities; risk assessment and control of contamination of air, environment due to exhaust, effluents, spillages and non routine incidents, operators gowning and laundry. The onus is on the manufacturer to show the risk of cross contamination is under control considering Pharmacological activity of the active, processes in place for inactivation and consistent cleaning of contaminants below HBEL, controls on exhaust, effluents, operator gowns and PPEs and their reuse, control of common areas. With very low HBEL levels and daily dosage levels for most sex hormones achieving the controls as per regulatory expectations could be very difficult in non dedicated facilities; the limits for acceptable cleanliness will be very low with practical issues on analysis and detection. The regulatory auditors will be very wary of the risk of contamination in non dedicated facilities and main focus of inspection will be cross contamination during operation as well as due to non routine incidents (e.g a power breakdown). Thus it makes sense to have dedicated facilities for sex hormones and other actives with high pharmacological activity/toxicity with low HBEL / PDE values
Refer the guidelines:
1. ICH Q7A, EMA Q&A on setting HBELs, WHO Annex 3 on GMP for Pharmaceutical Products containing hazardous substances
2. Refer Guidelines page on Qvents,in