Certificate of Pharmaceutical Product

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

For non-prescription and generic dmgs, the documentation required is simplified and is mostly concerned with chemical and pharmaceutical data. In general, the documentation required for registering products containing new chemical entities is more extensive than that for products in other categories (see Table 8.2). Countries that have the capacity to make an independent assessment of the safety, efficacy and quality of products, such as Australia, Estonia and the Netherlands, do not request the WHO-recommended Certificate of Pharmaceutical Product. Only Cyprus and Tunisia request price information. 

Issue of a Certificate of Pharmaceutical Product 250 (for each dose form of each product)... 

Free Sale Certificate/Certificate of Pharmaceutical Product... 

Certificate of Pharmaceutical Product or Free Sale Certificate (refer to section 12 of GUIDE) ... 

C6b Free Sale Certificate (FSC) or Certificate of Pharmaceutical Product (CPP) ... 

Premarketing control of locally manufactured, imported, exported and sold pharmaceutical products. This part deals mainly with the issuance of ministerial notifications, setting up quality and standards, technical review, inspection and testing before approval and granting of licenses for pharmaceutical entrepreneurs and registration certificates of pharmaceutical products. 

A certificate of pharmaceutical product of the type defined in the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce. ... 

Please attach a Certificate of Pharmaceutical Product according to the WHO Certification scheme (WHO Technical Report Series, No. 863). Earlier version is not acceptable. 

The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce was used in increasing the number of... 

A CFS and GMP certificate in the country of origin of the imported product must accompany the application for product registration. In cases where the product is packed by a different company, a GMP certificate of the packing company is required. The CFS must be issued by the authority recognised by the DCA—that is, the authorities listed in the World Health Organisation s (WHO s) Certification Scheme on the Quality of Pharmaceutical Products Moving in International... 

Regulations for the renewal of Registration Certificates for human use of pharmaceutical products were established by the CDMDR on 13 February 1997 and published in the Polish Pharmaceutical Journal. Renewal applications should be submitted for all products licenced before 1 January 1994 and those with expiry date of 31 December 1997. In the future applications for renewals should be made not later than six months before expiry date. Registration Certificates ending by 31 December 1997 were exempted from the rule. 

When the World Health Assembly recommended the first version of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in resolution WHA22.50 (1969), it accepted at the same time the GMP text as an integral part of the Scheme. The revised versions of both the Certification Scheme and the GMP text were adopted in resolution WHA28.65 in 1975. Since then, the Certification Scheme has been extended to include certification of ... 

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

Tablets and capsules Pharmaceutical ingredients Purified water Manufacturing environment Products Periodic after history is established accepted on supplier certificate of analysis Loop daily and taps weekly Quarterly Periodic after history is established due to low water activities of tablets and capsules...

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

Australia and the EC have entered into a Mutual Recognition Agreement (MRA) on conformity assessment of medicinal products. The TGA will accept a certificate of GMP compliance of a manufacturer issued imder this MRA by the official inspection services of the EU countries. This follows on from Australia s work over many years with the Pharmaceutical Inspection Convention, now known as the PIC/S. 

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