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

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Quality Assurance IssuesWHO Drug Information Vol. 25, No. 2, 2011the product approved in the certifyingcountry at the stated site, even if themanufacturing site is in a different countrythan the issuing authority.The Scheme has a provision that whenmanufacture takes place in a countryother than that where the product certificateis issued, an attestation that suchmanufacture complies with GMP may stillbe provided as an attachment to theproduct certificate on the basis of inspectionsundertaken for registration purposes.Q28 Is it necessary for the CPP to comefrom the country where finished productmanufacture takes place?A28 No. Although the Scheme was setup assuming that the certifying countrywas also the country where finishedproduct manufacture takes place, there isscope within the Scheme for CPPs to beissued by other authorities that canprovide independent assurance of theGMP compliance status.There needs to be an appreciation of thecomplexity of manufacturing and sourcingroutes currently employed by companiesoperating internationally. WHO MemberStates may define the source differently:• Country of finished product manufacture.• Country of final packing.• Country of final release.• Country of headquarters of the pharmaceuticalcompany, etc.A critical element is confirmation that allproduction/manufacturing/quality operationsare carried out according to GMP.Due to complex modern sourcing routes,together with varying local regulatoryprocesses, approval in the country wherefinished product manufacture takes placemay be subsequent to that in othercountries. In this case it is a matter ofjudgment whether it is necessary for theCPP to be issued from the country wherefinished product manufacture takes place.Preferred action, in order to speed uppatient access, would be to accept theCPP from the earlier approving country.In order to approve the product thecertifying authority must be assured ofGMP.GMP implementation and complianceensures product quality. Any requirementfor an additional CPP for the release site,if it is different from the product manufacturesite, will delay patient access becausemultiple CPPs provide no additionalvalue.Q29 What is the significance of thedeclaration of marketing status (i.e.,whether the product is actually on themarket in the exporting country)?A29 A declaration of marketing authorizationapproval is the aim of the CPP. It istrue that the WHO format CPP includesinformation on marketing status (if theproduct is actually on the market of theexporting country) but the Scheme alsohas a provision whereby the issuingauthority can indicate why the productmay not be marketed. In circumstanceswhere the product is not actually on themarket, the issuing authority can indicatethis on the certificate.The actual presence on the market of theproduct depends on many other factors.The recipient authority should not requirethat a product be marketed in the certifyingcountry.Q30 Should recipient authorities requirea CPP from more than one certifyingauthority?118
WHO Drug Information Vol. 25, No. 2, 2011Quality Assurance IssuesA30 No. They should not require a CPPfrom more than one certifying authority. AWHO-format CPP from a single certifyingauthority should provide appropriateevidence of approval and GMP status.Q31 Is it necessary for recipient authoritiesto require GMP certificates in additionto a CPP?A31 No. Since the CPP includes a GMPdeclaration, additional GMP certificatesare not necessary.Following introduction of the WHO CPPsome authorities no longer issue GMPcertificates (e.g., US FDA).In the presence of a CPP, separate GMPcertificates are redundant and are thereforediscouraged. CPPs should beaccepted (in particular from PIC/S andICH countries) as evidence of GMPstatus.However, outside of the Scheme, thereare occasions when it is appropriate torequire a GMP certificate.Q32 When a CPP forms part of a regulatoryreview, is it necessary to conduct asite inspection as well?A32 An inspection should not be necessarywhen the GMP declaration on theCPP covers the product to be approved inthe recipient country.Inspections outside of this condition are adecision which should be made by therecipient country. Mechanisms andsystems for recognizing inspectionscarried out by other authorities is encouragedto reduce duplication of inspections.CPPs should be accepted (in particularfrom PIC/S and ICH countries) as evidenceof GMP status. The decision toinspect should be made after a risk-basedassessment of the facility, taking intoaccount GMP and inspection statusprovided by other authorities.Q33 Imagine a situation in which companyA in one European country called Mproduces a pharmaceutical product calledX and the product is authorized formarketing in that country. Company Aalso produces X under contract manufacturingin country Z in Asia and wants toexport it to country Y in Africa. Theauthority in the importing country Yrequires a CPP to approve importation.(See figure 1 overleaf.)The questions are:Q33a Is contract manufacturing accepted?A33a Yes. Contract manufacturing isaccepted under GMP.Q33b In the case of a contract-manufacturedproduct, from which country shouldthe authority in the importing country(receiving authority) accept the CPP?A33b Country Z can issue a CPP if theproduct is registered by the authority ofcountry Z. If the product is not registeredin Z then the authority in Z cannot issuethe CPP.If the contract-manufactured product isalso authorized for marketing in theEuropean country, then the Europeancountry can issue the certificate.If the product is not registered in bothcountries, then the only country that canissue a certificate will be the Europeancountry, M. The authority of the Europeancountry will issue the CPP after it hassatisfied itself that the product undercontract manufacture is the same in allaspects as the one produced in its owncountry and that the product is producedin compliance with GMP.Q34 Can a CPP also be used to provideevidence of an administrative review andapproval, e.g., as certification of acceptabilityof a company name change?119
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WHO Drug Information Vol. 25, No. 2, 2011

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