qmssop049_01 supplier qualification

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Title:Supplier QualificationQMSSOP049 01

QualityAssurance

14/07/2015 14/07/2017 Page 1 of 1

!"#" $%is docu&ent is sc%eduled for re'ie( 2 years fro& t%e &ont% of t%e last appro'al date_________________________________________________________________________________________________

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Supplier Qualification

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!or Training &ontrolle0 &opy &opy !or Information "1solete


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Manage&ent #oard +esearc% , -e'elop&ent -epart&ent +egulatory Affairs -epart&ent

Quality Assurance -epart&ent Supply .%ain -epart&ent Sales -epart&ent

Quality .ontrol -epart&ent nfor&ation $ec%nology -epart&ent Mareting -epart&ent

Production -epart&ent Maintenance -epart&ent u&an +esources -epart&ent

R')$T'D *T$ND$RD "P'R$TIN+ PR"&'D(R'* ;*"P*ter& deli'ery contracts"5"1"4" Quality"5"1"5" ood correspond (it% t%e &onograp%"5"1"?" Manufacturer is specified in t%e registration dossier"5"1"7" :@periences"

5"2" Qualification of t%e suppliers

5"2"1" Addition of a ne( supplier s%all *e done t%roug% c%ange control syste& according to SOPnu&*er QMSSOP021"

5"2"2" $%e reuired 666666666666 specifications s%all *e sent to t%e supplier and necessary sa&ples of &aterial B different *atc%esC s%all *e reuested for testing at 666666666666

Quality .ontrol depart&ent"

5"2"" A trial *atc% of t%e finis%ed product s%all *e prepared and e'aluated *y +,- depart&ent and fulltesting of t%e t%ree sa&ples *y Quality .ontrol depart&ent s%all *e done to &easure t%e&aterial perfor&ance"

5"2"4" +esults of all t%e t%ree sa&ples s%all *e co&pared (it% t%e results on &anufacturerDs certificateof analysis"

5"2"5" f t%e test results generated *y 666666666666 Quality .ontrol and +,- depart&ents arefound to *e satisfactory a supplier uestionnaire s%all *e sent to t%e supplier to ensure t%atadeuate process controls are in place and cMP reuire&ents are in co&pliance as per

Appendi@ A B


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5"2"11" f t%e supplierDs site auditing s%o(s t%at supplier &eets cMP reuire&ents as esta*lis%ed *y666666666666 Quality Assurance auditor or depending on t%e certificate8s of inspectiont%e supplier s%all *e as a certified supplier"

5"" +educed $esting

5""1" Quality Assurance and Quality .ontrol Managers s%all decide for reduced testing of inco&ing&aterial recei'ed fro& t%e supplier according to t%e supplier status 8Appro'ed / certified"

5""2" Once starting reduced testing Quality control Manager s%all deter&ine t%e selection ofappropriate tests reuired to accept &aterial fro& supplier under t%e reduced testing progra& >depending on t%e sa&pling sipping plan >" Selection s%all *e *ased on test criteria (%ic% candetect potential uality c%anges of &aterial during %andling and transportation fro& t%e supplierto 666666666666 (are%ouse"

5"4" f any uality issues arise B-e'iation Out Of Specification .%ange reuest etc"C i&pactassess&ent on t%e appro'ed status s%all *e e'aluated" ncrease testing or full testing s%all *econsidered till issues resol'ed"

5"5" f one or &ore lot / *atc% are reFected *y Q. for an appro'ed supplier an in'estigation needs to*e conducted *y uality assurance to deter&ine cause and to esta*lis% t%e reuired .APA"

5"?" %en c%anges are notified *y t%e supplier i&pact assess&ent on t%e appro'ed status s%all *ee'aluated and any necessary action8s taen" $%is &ay include a period of increase or full testingafter t%e c%anges %a'e *een i&ple&ented"

5"7" Any a&end&ent of t%e testing progra& as a result of t%is factor s%all *e considered"

5"3" Once c%anges %a'e *een satisfactory i&ple&ented and /or uality issues resol'ed t%e &aterialcould *e returned to its reduced testing progra&"

5"9" A periodic re>ualification of suppliers s%all *e done *ased on re'ie( of correspondence (it% t%esupplier a*out facilities process or control &et%od c%anges and re'ie( of inspectional %istory ofsupplier *y 666666666666"

5"10" -isualification of suppliers

5"10"1" Any supplier can *e disualified under follo(ing circu&stances

5"10"1"1" nconsistent uality (%ic% &ay affect drug product sta*ility"

5"10"1"2" rregular supply including e@tre&e delays in supplying t%e &aterial as per ti&eco&&it&ent pro'ided *y suppliers"

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5"10"1"" .%anging t%e &anufacturing process cross conta&ination i&proper la*eling infor&ationor s%elf life of AP (it%out proper notification to 666666666666"

5"10"2" QA s%all issue a (ritten co&&unication to Supply .%ain Manager for disualifying any supplier(it% proper Fustification"

5"10"" -isualified supplier s%ould *e reassess&ent after i&ple&entation t%e needed .APA fordisualification reasons"

9. $PP'NDI&'*

?"1" $ppen0ix $ Supplier Questionnaire 8


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$ppen0ix $Supplier Questionnaire 8


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5- Does +atch identity allo! for tracea+ility of:6.1. nput materials?

Yes/no6.2. n-process chec"s?

Yes/no6.3. inal product testin#?

Yes/no6- $re any materials manufactured at more than one site?

Yes/nof yes please name other sites and #i*e their location.'''''''''''''''''''''''''''''''''''''''''''..

- $re these records formally e*aluated +y 7uality $ssuranceyes/no

8- $re all personnel a!are that materials are for pharmaceutical use?Yes/no

9- $re products manufactured to a !ritten procedure?Yes/no

1-$re !ritten records maintained for each +atch #i*in# a complete recordor the manufacturin# history i.e.11.1. ;,uipment used?

Yes/no11.2. Description ,uality and +atch num+er of ra! materials used?

Yes/no11.3. Date of manufacture?

Yes/no11.4.


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12-$re re=ected materials clearly identied as such?

Yes/no

13-s disposal of re=ected materials re!or" of intermediates or nishedroduct co*ered +y a !ritten procedure?

Yes/no

14-$re di>erent #rades of materiali.e. pharmaceutical / technical manufactured on the same plant?

Yes/no

15-Do you ha*e a trainin# pro#ramme for:16.1. roduction personnel?

Yes/no16.2. 7uality assurance personnel?

Yes/no

16-$re records "ept of any trainin# recei*ed +y:1.1. roduction personnel?

Yes/no1.2. 7uality $ssurance personnel?

Yes/no

1-Do you ha*e a formal system of e,uipment and line clearance?Yes/no

18-Do you ha*e a yield reconciliation system?Yes/no

19-Do you retain samples from each +atch?Yes/nof yes for ho! lon#? '''''''''''''''''''''''''''''''.

2-Do personnel !ear #arment appropriate to the =o+?Yes/no

21-s there e*idence of e>ecti*e pro#rammes in place to address safety and@ccupational health and hy#iene matters?

Yes/no

22-$re la+els and printed materials stored ade,uately?Yes/no

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23-s reconciliation of la+els satisfactory?

Yes/no

24-Do you handle any +eta-lactam anti+iotics at the same site?Yes/no0e#. enicillins cephalosporins or related anti+iotics

Quality assurance:

1- s the ,uality function or#anied as a separate:1.1. 7uality &ontrol department?

Yes/no1.2. 7uality $ssurance department?

Yes/nof there is no dened ,uality function !ho is responsi+le for assurin#

Ahe material meets the re,uired specication?''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''0position

2- s the ,uality assurance instruction manual a*aila+le and is it "ept up to date?Yes/no

3- $re chan#e control and de*iation procedures esta+lished?Yes/no

4- s there an esta+lished procedure for handlin# complaints?Yes/no

5- hich aspects of your operations are co*ered +y 7$/7&?2.1. Aestin# incomin# materials?

Yes/no2.2. n-process controls?

Yes/no2.3. inal product testin#?

Yes/no

6- Ao !hom does the person responsi+le for ,uality report?............................................................................................................''''''''''''''''''''''''''''''''''0position

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- s your company re#istered !ith one of the current ,uality standards@r#aniations?

Yes/noBention them'''''''''''''''''''''''''''.

8- Does your ,uality function ha*e the responsi+ility to release or re=ect;ach +atch of:5.1. Ctartin# materials?

Yes/no5.2. ntermediate product?

Yes/no5.3. inished product?

Yes/no

Certicate of analysis:

1- $re certicate of analysis a*aila+le for the ra! materials supplied to?

Yes/nof no !ould you +e prepared to ne#otiate !ith %%%%%%%%%% !ith aie! to supplyin# a suita+le certicate?

Yes/no

2- ould the certicate actually reEect an analysis on the particular +atch?Yes/no

Eniron!ental:

1- Do you ha*e an en*ironmental policy?Yes/nof yes !ill you please supply a copy

Sales:

1- ho is responsi+le for dispatch from supplier to customer?''''''''''''''''''''''''''''''''''''''''''''''''''''''''..

2- $re the supportin# sales documents relatin# to the customer and the +atchretained? Yes/no

3- )o! are the accuracy of the deli*ery and adherence to deli*ery dates #uaranteed?''''''''''''''''''''''''''''''''''''''''''

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''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''

. D"&(%'NT DI*TRI,(TI"N $ND R'TRI'V$)

*"P Distri1ution *"P Retrieval

-epart&ent+ecipientSignature/date

!o" of copiesrecei'ed

!o" of copiesretrie'ed

+eason+etrie'ed *ySignature/date

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qmssop049_01 supplier qualification

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