WHO Drug Information Vol. 25, No. 2, 2011

WHO Drug Information Vol. 25, No. 2, 2011Quality Assurance IssuesWHO Certification SchemeThe WHO Certification Scheme on the Quality of Pharmaceutical Products Movingin International Commerce is an international voluntary agreement mechanism whichprovides information to participating countries on the quality status of finished pharmaceuticalproducts moving in international commerce. The primary focus of theScheme is the Certificate of a Pharmaceutical Product (CPP).The WHO Expert Committee on Specifications for Pharmaceutical Preparations(ECSPP) recommended that the WHO Certification Scheme on the Quality of PharmaceuticalProducts Moving in International Commerce should be reviewed in linewith changing practices and rapid globalization of the pharmaceutical manufacturingsector, regulatory environment and procurement systems. However, the Schemecan only be opened for revision by decision of the World Health Assembly (1). As aninterim measure, the ECSPP requested that a question and answer document onthe functions of the Scheme should be prepared (2). Version one of the documenthas been developed with the aim of improving understanding of the objectives of theScheme and its implications for quality improvement and provision of effective, safemedicines by participating countries. Comments and suggestions on this documentmay be sent to Dr Samvel Azatyan, Medicines Regulatory Support Programme, WorldHealth Organization, 1211 Geneva 27, Switzerland, or e-mail: azatyans@who.int.WHO Certification Scheme:questions and answersQ1 What is the WHO CertificationScheme on the Quality of PharmaceuticalProducts Moving in International Commerce?A1 It is a Scheme developed by theWorld Health Organization (WHO) inresponse to the request of WHO MemberStates to facilitate international trade inpharmaceutical products between MemberStates.Q2 When was the Scheme developed?A2 It was first developed in 1975. Sincethen it has been revised in 1988, 1992and in 1997.Q3 How can it facilitate trade in pharmaceuticalproducts?A3 The Scheme is an administrativeinstrument that requires a participatingMember State (a certifying country), uponapplication by a commercially interestedparty (the applicant company), to certify/attest to the competent authority ofanother participating Member State (therecipient country) that:• A specific pharmaceutical product isauthorized for marketing in the certifyingcountry, or if not, the reason why authorizationhas not been accorded.• The manufacturing facilities and operationsconform to good manufacturingpractices (GMP) as recommended byWHO.113