Hi,
In a facility designed to manufacturing of cytotoxic products ( closed system) , is it allowed to manufacture other class category of products in same facility based on risk assessment ?
Separation or dedication of equipment and facilities for the manufacture of potent compounds is not specifically required by CGMP regulations. However, manufacturers should identify drugs with such risks and define the controls necessary to eliminate risk of product cross-contamination in nondedicated equipment and facilities. Such controls include proper cleaning, cleaning validation, and other contaminant controls. Firms must validate that cleaning procedures are adequate to ensure that cross-contamination does not occur. CGMP regulations establish requirements to guide development and execution of cleaning validation plans.
In designing a facility, firms should carefully evaluate manufacturing processes to determine the best procedural controls and floor plan—optimizing the flow of materials, equipment, and people—to help prevent product contamination.
References:
- 21 CFR 211.42: Design and construction features
- 21 CFR 211.67: Equipment cleaning and maintenance
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