Archived Newsletters
Global Good Manufacturing Practices
Barbara Kanegsberg and Ed Kanegsberg
Whatever you manufacture – automobiles, electronics, medical devices - and wherever in the world your manufacturing plants are located - London, Philadelphia, Beijing - take a moment to look over our assessment and interpretation of a recently released document. “Good Manufacturing Practice for Pharmaceutical Products” (GMP) is now in effect and subject to governmental enforcement in China.
Helpful Roadmap
If you are planning a new process, if you are concerned with critical cleaning and contamination control, if you are involved in method acceptance or cleaning process validation, this GMP provides a useful roadmap. Based on our experience in preventing and resolving a range of contamination control problems, we find that many aspects of this GMP are applicable to those concerned with manufacturing high-value product in many areas of manufacturing, not just those related to pharmaceuticals. Those of you involved in providing contamination control products and support services will also find it productive to understand the implications of the new GMP.
Logic, Education, Documentation
The GMP emphasizes science, logic, documentation and educated employees. 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. The enforcement system includes governmental inspection and certification. New and remodeled pharmaceutical manufacturing facilities have to comply immediately. All facilities must comply within five years.
Nimble Management
By conventional wisdom, the GMP would appear to 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. Wherever you are in the world, whatever you manufacture, your own nimble and savvy company may choose to adapt pertinent portions to improve your own manufacturing stance.
Read more
Our comments are featured on the website of the Global Society for Contamination (GSFCC), a non-profit peer-to-peer global learning community for contamination control professionals.
Click here to go directly to our evaluation
http://gsfcc.org/index.php?title=An_Evaluation_of_the_Revised_Chinese_Good_Manufacturing_Practice_for_Pharmaceutical_Product#An_Evaluation_of_the_Revised_Chinese_Good_Manufacturing_Practice_for_Pharmaceutical_Products
