GUIDELINES ON THE IMPLEMENTATION OF THE WHO CERTIFICATION SCHEME ON THE QUALITY OF PHARMACEUTICAL PRODUCTS.
Nidhi S. Ghetiya*, Darshil B. Shah and Dr. Dilip G. Mahesvari
To facilitate use of the World Health Organisation (WHO) Certification Scheme, a set of guidelines was developed in 1996, which includes model certificates for use by Member States. Today, the scheme provides transparent information, particularly about the regulatory status of a product in export the country. If used properly, the product certificate and batch certificate can provide a basis for product registration. This article covers the strengths and weaknesses of the scheme.
Keywords: World health organization; Certificat Scheme; Good Manufacturing practice (GMP); Health Systems and Innovation (HIS); Essential Medicines and Health Products (EMP).
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