Pharmaceutical manufacturing regulatory framework

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (19) This guidance describes a regulatory framework that will encourage the voluntary development and implementation of innovative approaches in pharmaceutical development, manufacturing, and quality assurance. Many new... 

It also contains some information on the regulatory framework in these countries. There is some information about Mexico, but the self-regulatory code could not be found. In addition there are some overarching international codes of conduct, such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) code, the World Health Organization (WHO) guidelines and the European Federation of Pharmaceutical Industries and Associations (EFPIA). 

Pharmaceutical manufacturers face constant competitive and regulatory pressure to upgrade their technological capabilities, and the evolutionary framework of analysis emphasizes the extent to which this upgrading relies on both firm-level investment building on existing capabilities, and also on the benefits that accrue from its surrounding industrial base. Chapter 1 briefly noted that African countries broader... 

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