Conference Report: A Practical Approach to the International Conference o­n Harmonization Q7A GM

The future is now for manufacturers of Active Pharmaceutical Ingredients (APIs) with the publication of the Q7A Guidance for Good Manufacturing Practice. San Juan, Puerto Rico was the site for a comprehensive workshop, sponsored by the Parental Drug Association (PDA), Generic Pharmaceutical Association (GphA), Pharmaceutical Research and Manufacturing Association (PhRMA), and the U.S. Food and Drug Administration (FDA). This workshop had two main goals: to introduce the basic concepts of the Q7A guidance, and to offer a glimpse of the rationale and intent of the designers of the document as it applies to API. Each section of Q7A was presented by a member of the Expert Working Group (EWG) who, under the umbrella of the International Conference o­n Harmonization (ICH), forged the guidance in an effort to bring direction and consistency to API manufacturing.
The Q7A guidance is a historical document because it represents the first internationally harmonized tripartite GMP guidance developed jointly by industry and regulators under ICH direction. It establishes o­ne global GMP standard for API, and intends to provide mutual recognition of GMPs in API production. It impacts any manufacturer, worldwide, that markets API throughout those countries that are members of the World Health Organization (WHO), including those that use API in non-prescription drug products.


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