PIC/S To Guide Member Inspectorates On Harmonizing GMP Deficiency Classifications
Draft guidance soon will help the world’s leading pharmaceutical inspectorates align views on which drug GMP deficiencies are considered major – and which are truly critical.
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As more and more regulatory authorities line up to join the informal co-operative scheme for pharmaceutical inspectorates, PIC/S, there are plans to discuss the possible introduction of an annual reporting scheme to check ongoing compliance by existing members.
PIC/S has issued guidance to help member pharmaceutical inspectorates classify good manufacturing practice deficiencies to ensure there is a consistent view across inspectorates as to which deficiencies are “critical” or “major.”
Medicines regulators in Mexico and Argentina have agreed to exchange good manufacturing practices inspection certificates.