Copp- Certificate of Pharmaceutical Products

Copp- Certificate of Pharmaceutical Products
for UG and PG Students

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Is needed by the importing country when the product in question
is intended for registration (licencing, authorisation) or
renewal (prolongation) of registration,
with the scope of commercialisation or distribution in that
country.
Certification has been recommended by WHO to help
undersized drug regulatory authorities or drug regulatory
authorities without proper quality assurance facilities in
importing countries to assess the quality of pharmaceutical
products as prerequisite of registration or importation.

4. TheapplicationforgrantofWHOGMPCertificateof
PharmaceuticalProductshallbemadetorespective
zonal/subzonalofficersaspertherequirement.
TheCOPPwillbeissuedbyzonal/subzonalofficerson
behalfofDrugsControllerGeneral(India)after
inspectionandsatisfactoryclearancebyCDSCO
officersasperWHO–GMPguidelines.
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5. Aforwardingletter/applicationshallbe
addressedtoDDC(I)/ADC(I)ofrespective
CDSCOzonal/subzonalofficeswithcopyof
coveringletter&productsummarysheetto
DCG(I)byauthorizedpersononly.
ADC(I):AssistantDrugController(I)
DDC(I):DeputyDrugController(I)
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6. Applicationshouldclearlyindicateforfresh
certification(Grant)orreissueofproductsapplied,
accordinglyitwillbescrutinizedfortheproducts
applied.
ApplicationswillbereviewedbyCDSCOofficersand
completedapplicationsinallrespectswouldbe
acceptedforinspectiononfirstcomefirstservebasis
Theforwardingletter/applicationshallbeaccompanied
withListofproductsappliedforgrantofCOPP,along
withtheaproductpermissioncopy(manufacturing
licenceissuedbytheSLA)&notarizedproduct
summarysheet,sitemasterfileasperWHO-GMP
requirement
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7. Listofmajor/masterdocumentslikemastervalidationplan,
qualitymanuals,specifications,masterformularecords
maintainedbyfirmandlistofSOP’s(toindicatethe
documentationsystemoffirm).
Manufacturing layout.
Listofpersonnel(withdesignation,qualification&
experience),Listofequipments,instruments,utilitiesalong
withmakeandmodel&capacity.
Listofprimary&secondaryImpurityandReference
standards/culturesavailablewiththefirm(relevanttothe
appliedproductsforgrantofCOPP).
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Applicationsforwardedbefore01‐10‐2009willbeconsideredprovided
theyshouldresubmittheapplicationintherevisedformatwith
forwardingletter,notarizedproductsummarysheetandotherdocuments
whichwerenotsubmittedearlierasperrequirementonfirstcomefirst
servebasis.
AllapplicationsreceivedwillbescrutinizedbyCDSCOOfficialsafter
receiptandqueryletterwillbesenttoapplicant,ifanyorotherwisewill
beconsideredforinspection.
InspectionwillbecarriedoutbyCDSCOOfficersasperWHOGMP
guidelinesofTechnicalReportSeries(TRS)TRS823/908fornon
sterileproducts,TRS822/902forSterileProductsandotherrelevant
guidelinesinTRS937,TRS929,TRS863etc.asapplicablefromtimeto
time.

9. SelfappraisalchecklistshouldbefilledandsubmittedtoCDSCO
officerbeforeinspection.
Inspection team verify the checklist at the time of inspection.
Inspectorsbrief the inspection findings at the exit meeting
ThereportshouldclearlydefinedeficienciesasperWHOGMP
guidelines.
RespectiveZonal/Sub‐Zonalcertifyingauthorityprepare“Review
Report”basedonreviewofobservationsofchecklistandwritten
inspectionreportasperWHOGMPguidelines.
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10. Firm may reapply, if required after proper compliance after
5months from date of rejection.
If the same firm applies after 5 months, scrutiny of such application
should be asked for earlier compliance with documentary evidences in
addition to the usual general requirements for submission of application
for issue of COPP
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This certificate conforms to the format recommended by the World Health
Organization
No. of certificate
Exporting (certifying country):
Importing (requesting country):
1.Name and dosage form of the product:
1.1.1. Active ingredient(s) and amount(s) per unit dose
2.1.2. Is this product licensed to be placed on the market for use in the
exporting country?(yes/no)
3.1.3 Is this product actually on the market in the exporting country?
If the answer to 1.2. is yes, continue with section 2A and omit section 2B. If
the answer to 1.2 is no, omit section 2A and continue with section 2B:

13. 1.Number of product licence and date of issue:
2.Product licence holder (name and address)
3.Status of product licence holder:
1.For categories b and c the name and address of the manufacturer
producing the dosage form is:
4.Is a summary basis for approval appended? (yes/no)
5.Is the attached, officially approved product information complete and
consonant with the licence?
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(yes/no/not provided)
6.Applicant for certificate, if different from licence holder (name and
address):
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2.A.

14. 2.Status of applicant:)
3.Why is marketing authorization lacking? (not required/not
requested/under consideration/refused)
4.Remarks:
3. Does the certifying authority arrange for periodic inspection of the
manufacturing plant in which the dosage form is produced? (yes/no/not
applicable)
If not or not applicable, proceed to question4
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15. 3.1. Periodicity of routine inspections (years)
3.2. Has the manufacture of this type of dosage form been inspected?
(yes/no)
3.3 Do the facilities and operations conform to GMP as recommended
by the World Health Organization?(yes/no/not applicable)
4. Does the information submitted by the applicant satisfy the certifying
authority on all aspects of the manufacture of the product: (yes/no)
If no, explain:
Telephone: Fax:Name of authorized person: Signature:
Address of certifying authority:Stamp and date

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Reference:
•http://apps.who.int/medicinedocs/en/d/Jwhozip43e/
16.html#Jwhozip43e.16