Phoenix, AZ (WiredPRNews.com) An expanded, comprehensive Chinese “Good Manufacturing Practice for Pharmaceutical Products” (GMP) is in effect. The GMP requires immediate compliance by new and remodeled pharmaceutical manufacturing facilities. All facilities must comply within five years. The system includes governmental inspection and certification. An assessment and interpretation of the GMP by contamination control experts Ed and Barbara Kanegsberg is available on the GSFCC website under the “Classifications and Standards” section.
Contamination control professionals providing products and support services will find it productive to understand the implications of the new GMP. Manufacturers must have scientifically-based procedures as well as complete, unambiguous documentation. Processes must be validated, monitored, and revalidated on an ongoing basis. Inspection and monitoring of suppliers by the manufacturer is required.
By conventional wisdom, the GMP might favor larger companies. However, small to mid-sized companies with a nimble management system and a philosophy of cooperation and communication might be particularly adept at implementing the new approach.
The Global Society for Contamination Control (GSFCC) is a non-profit peer-to-peer global learning community for contamination control professionals.
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