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Tuesday, September 1, 2009

approved manufacturing equipment drugs pharmaceutical manufacturing provided FDA

Obviously it is not some exception of asbestos and fiber-releasing filters see CFR 211.72.

The any FDA do not provide such list , neither any CGMP regulations approve nor prohibit specific equipment for use in manufacturing of pharmaceutical products (with the some exception of asbestos and fiber-releasing filters by US FDA, see CFR 211.72).  US FDA says they do not provide any list of approved equipment.  Pharmaceutical manufacturing companies can select any equipment that meets all CGMP requirements and satisfies their particular needs. Individual pharmaceutical manufacturer is responsible for selecting all such equipments for their manufacturing process to produce quality product in accordance with CGMP.  The selected equipment should meet all requirements of CGMP , you can modify standard equipment designs to best suit your process , equipment should be compatible with the product under process.

The CGMPs requires that an equipment should be of appropriate design so as that it facilitate operations for its intended use and for cleaning and maintenance (see CFR 211.63 and CFR 211.67) and, that any equipment surface in contact with components, in-process materials, or drug products should not be reactive, additive, or absorptive so as to "alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements" (see CFR 211.65).

What are the References for above discussion?
21 CFR 211.63: Equipment design, size, and location
21 CFR 211.65: Equipment construction
21 CFR 211.67: Equipment cleaning and maintenance
21 CFR 211.68: Automatic, mechanical, and electronic equipment
21 CFR 211.72: Filters

Regulatory affairs in pharmaceutical industry
Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing

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Regulatory Affairs in Pharmaceutical Industry

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