Aug 5 2011
For manufacturers who must comply with current Good Manufacturing Practice (GMP), keeping track of the latest guidelines can be time consuming and difficult. This task is considerably more complex if the manufacturer exports to multiple countries, each with their own GMP requirements.
PharmOut, a professional consultancy specializing in GMP compliance, has created an online database of GMP guidelines. This database, available at http://gmp.pharmout.net, is free to access and allows the user to search across all English language GMP guidelines, past and present.
"Take the example of a penicillin manufacturer," said Trevor Schoerie, PharmOut's Managing Director. "If they export to multiple countries and they are planning a change to their facility, they would have to go to each country's regulatory website, download the appropriate GMP guidelines and then search each document. Using the online GMP Library, they can do one search - across all the GMP guidelines. Our consultants have been using this powerful tool for some time and we are now making it available to the industry. The GMP Library makes it easy for manufacturers to determine the highest GMP standard they must comply with, across the countries they ship to."
Bob Tribe, former Chairman of the Pharmaceutical Inspection Cooperative Scheme (PICS), commented, "Regulators recognize that globalization and outsourcing have redrawn the path that drugs navigate to reach the end consumer. The supply chain from manufacturer to consumer has become complex, involving a global web of intermediaries. Companies within this supply chain must keep up to date with the GMP requirements of all the countries they supply to. Whilst harmonization of GMP requirements is certainly making compliance simpler, tools like PharmOut's searchable GMP library will be invaluable for those who must comply with multiple GMP requirements."
SOURCE PharmOut
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