annual

1.0PURPOSE:

Toperformtheannualreviewofcomplaints,recalls,returnedorsalvageddrugproducts,

notificationofrejectionforms,outofspecificationresultforms,criticalsystemchangecontrol

forms,investigation/deviationreportforms,productspecifications,manufacturingandcontrol

procedures.

2.0SCOPE:

2.1AllCustomercomplaints,recalls,returnedorsalvageddrugproducts,notificationof

rejectionforms,outofspecificationresultforms,criticalsystemchangecontrolforms,

investigation/deviationreportsthatoccurredthroughouttheyearwillbereviewedonan

annualbasis.

2.2Appliestoallproductsandthedocumentspertainingtotheirmanufacture.

3.0RESPONSIBILITY:

3.1ItistheresponsibilityoftheQualityControl/StabilitySystemsTechniciantopreparea

parateannualreportoneachproductthatismarketedbyCompany.

3.2TheQualityAssuranceAssistantScientistand/ortheQAManagerisresponsiblefor

reviewingthedocumentationfromlectedbatchesofeveryproduct.

3.3TheQA/QCDirectorand/ortheQAManagerand/orQCManagerareresponsiblefor:

3.3.1Reviewingeachproductsannualreport.

3.3.2Performreviewofrecalls,returnedorsalvageddrugproducts,notificationof

rejectionforms,outofspecificationresultforms,criticalsystemchangecontrol

forms,investigation/deviationreportforms.

3.4TheRegulatoryAffairsParalegalisresponsibleforprovidingasummaryannualreview

reportofallcomplaintsbyproduct.

3.5TheRegulatoryAffairsDirectorisresponsibleforreviewingthesummaryannual

complaintreport.

3.6TheQA/QCDirectorisresponsiblefornotifyingtheresponsibleofficialsofthecompany

inwritingifaninvestigationisperformedonReturnedDrugproductsoronDrugProducts

thataresalvagedbecauofimproperstorageconditions.

4.0PROCEDURE:

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Quality

SOP

AnnualReviews

SOPNo.:M-050

Effective:

Superdes:11/8/01

Page2of2DBC:6.17

4.1Therecordsassociatedwithalectedbatch/lotoffinishedproductforeachbulkformula,

includingallrawmaterialandpackagingmaterialrecordsthatareudtomanufactureand

packagethebatch/lotofproductarereviewedforcontentandcompletenessannually.

4.2Therecordsforcomplaints,recalls,returnedorsalvageddrugproducts,notificationof

rejectionforms,outofspecificationresultforms,criticalsystemchangecontrolformsand

investigation/ualreviewfilecontainstheQC

reviewresultssummarizedbyproduct,QAresultssummarizedforeachbulkformulation,

andtheRegulatoryAffairsresultssummarizedbyproduct.

4.2.1TheRegulatoryAffairsParalegalwilllogallcomplaintsforeachproductonalist,

indicatingthetypeofcomplaint,it’stis

reviewedbytheRegulatoryAffairsDirectortodetermineanysignificantchanges

infrequencyortypeofcomplaintforeachproductfrompreviousyears.

4.2.2Thecausforanyrecallswillbeexaminedandaninvestigationwillbeperformed

ortofthe

investigationisissuedtotheresponsibleofficialsofthecompany.

vestigationisrequired,the

responsibleofficialsofthecompanywillbenotified.

4.2.4NotificationofRejectionFormsarereviewedandsummarizedfortrends.

4.2.5CriticalSystemChangeControlformsarereviewedforcompleteness.

4.2.6OutofSpecificationResultFormsarereviewedandsummarizedfortrends.

4.2.7Investigation/DeviationReportsarereviewedtodetermineanytrends.

Recommendationsforimprovementinanareawillbegiventothecorrect

departmentmanager.

4.3Eachproduct’sannualreport,whichcontainsthefollowing,isreviewed:

4.3.1S

ducthasno

expirationdatethenresultsarerecordedforatleast48monthsandreviewed.

a

aretabulatedinanExcelspreadsheetandasummaryisgeneratedforeachproduct.

4.4Productspecifications,ProductControlProcedures,thecurrentFormulaandthe

ManufacturingProceduresareupdatedasneededbadontheannualreview.

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Quality

SOP

AnnualReviews

SOPNo.:M-050

Effective:

Superdes:11/8/01

Page3of2DBC:6.17

4.5Theannualreviewisdocumentedand

filed.

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Quality

SOP

AnnualReviews

SOPNo.:M-050

Effective:

Superdes:11/8/01

Page4of2DBC:6.17