Agencies, Industry Look to Standardize, Focus Global Inspection Processes
This article was originally published in The Gold Sheet
PIC/S, the world’s ‘club’ of pharmaceutical inspectorates, is considering making life easier for manufacturers by helping members align their views on deficiencies and reduce inspection redundancies. But much depends on the club’s ability to bring more inspectorates into the fold, particularly those of the emerging BRIC nations.
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Draft guidance soon will help the world’s leading pharmaceutical inspectorates align views on which drug GMP deficiencies are considered major – and which are truly critical.
PIC/S could play an even greater role in coordinating drug GMP inspections if its members included inspectorates of all the major drug exporting nations. While India appears to lack interest, Japan, China and others have been working to qualify for membership.