“The CGMP regulations neither approve nor prohibit specific equipment for use in manufacturing of pharmaceutical products (with the exception of asbestos and fiber-releasing filters, see 211.72). We do not maintain a list of approved equipment. Firms are afforded the flexibility to select equipment that best satisfies their particular needs and that is capable of meeting the relevant CGMP requirements. Each firm is responsible for selecting all equipment used in their manufacturing process to produce quality product in accordance with CGMP.

 The CGMPs require that equipment be of appropriate design to facilitate operations for its intended use and for cleaning and maintenance (see 211.63 and 211.67) and, that any equipment surface in contact with components, in process materials, or drug products 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 211.65).

 It should be noted that it is a firm’s responsibility to develop and validate test methods capable of detecting contamination in their manufacturing facilities. Persons engaged in the processing, packing, or holding of a drug product for administration to humans or animals are subject to 21 CFR Parts 210 through 226. This generally means that drug product manufacturers must comply with all applicable sections of the regulations including, but not limited to, those sections pertaining to quality control, personnel qualifications, building and facilities, equipment, production and process controls, packaging and labeling controls, laboratory controls, and records and reports.”

Diane Raccasi
CSO/Microbiologist
Center for Drug Evaluation & Research, Office of Compliance
Division of Manufacturing & Product Quality
US Food and Drug Administration (FDA)
10903 New Hampshire Ave W051-RM 4355
Silver Spring, MD 20903
(301)796-3927
Diane.Raccasi@fda.hhs.gov