» osopynonanne 6.C Qualification documentation (fee you wil ine answers tothe folowing questions lat are the component ofthe qualification docurertation?| How the quacation mast plan organised? What does aquelicaton 0° consetot? ‘A qualieston actos must be documented i wing a= otherwise they wil rot be reproducible (documented evidence), The quaifiation documentation consists of quitation protcols, the ‘sualication ports (ee gre C1) andthe eualiieation master plan fpesin vaticaton Jauaicavonpotocl [autitcation report > cepavcnuse cuerewss > suore nomewierna fesataton qualiteaton [auacaonprotoal [auaicaon report, lppeatonal ealication [Quaicaonprotoal + norneriea lavacavon report Fevorance qalfcnon|Quaicaon prota + one lavarcaon report, > remionorwuecini neouece ‘ woureons xauecrsa = reicame) AEATENBNOGTE * camonienexune > gmp emupe + reemmaonocua, rout Figure 6.61 Overview of qualification neaing Socamentation “The euuctutlogaisaton of he quate ion prtocale and reports shown in gure 6.62. [peal organisation ofa qualification protocol and report fvalieaton plan faticaton report Introsscon Inroducton lessroton ofthe recess esse feserption ofthe facity Isummary/evauatin leczrption ofthe cS/ysten/eontatpocument it fearing out proval signatures fespone ities Fisk arabs rest plans wih acceptance criteria changes provalsgnetres Fipwe 6.02 Organisation ofa qualification protocol end report ‘Quatiiaton protocols and reports are brought int orce/signed a foows: ‘Complation at department lve. eg equipment administrator andor echricn, “eat at deparment level eg. eaomentadminsrator and/or technician (ot identical wth comple) Release at formal ee, © valdaton representative and/or hea of producton/quay contol and quality management. 6.C.1 Qualification master plan sone 15 of he EU GMP Gudsine only recognises the valdtion mast: plan Ray be hlpfulto create 8 {ualication maser plan that is subsequertl iterated it the validation masterplan depending onthe “The qualia master plan may be a component ofa superonate vation masterplan (chapter 7 Validation aster pan. “The qualileaton masterplan is a sel project management tol which used o achiev the follwing Detniton othe gualiication sey Description ofthe orgaisatonal structures an responsbiies Defnton ofthe scope ofthe intended uaifation actives SStucurng nd port sein of scivbes Defntion of the working basis (operating procedures, internal/extemal guidelines, requrements forthe documents layout doe. na, change col), aneDefnton of eehesuee Reterecing and desertion of documents Defniton af ange contol change managementivtsion contol) “The qualfation masterplan seniesqualfienton tems (= equipment) and desies qualification steps pe and cope) forthe qulfcaton activist be eared out for each ter, In aceon the masterplan eserbes te responsbtis during qualfcaton. “Te core cement ofa qualfeation mas 3. + pln fst ofthe qulficston tems and» schedule (nut 6: [eaten et ecamennion tem [scope ‘pens [(elan, report), deadlines| Jsserertien ]oa7r00 — Guafxton wan laPor ows ecine) (see otc |" I" . Jaao1 os/os fscereritem2|oq7r0arPa Guaaton eam ane prtocoi|aP02 107008 erospetie) lose ore fecererttem|oq7aroq _fuaiaton eam ane protca)|aP09 07005 Irospecne 00s cos Fpwe 6.03 Extract of 2 qualfcation masterplan Acdrionaly references are made to geeral working bases nthe qualification maser pla. Ths means that the applicable (comparyinteral| gudeines and operating procedures are stated in relation to the cganisztovimplementaton ofthe qualifcation or requaliicaton, requvements forthe qualfiestion ‘ocamentation as well as devitlon and change contralpocesures. ‘The qualification masterplan @ comprehensive umbrella document containing references to subsequent execute regulations (operating procedures). The qualicction masterplan must rect the opratoral veumstences and mast therefore be updeted I hese cicumstaces change (2g new equlpmen) ‘Qualicaton master plans canbe crested 2s @ management document fran entice ste/company, I may ‘then be usefUl to label ths plan as Ste Qualtieation Master Pon. Qualeavon masterplan can elso be treated especialy fr large projects. & higher degree of deal is then necessary eg, mail flow, personel ow andthe Be 6.C.2 Qualification plan “The qualfieston protools (as they are cefered to fn the Indus) are dered frm the rgulatony requrement for documerted and predetermined specications whch atthe outset define in del the procedure and responstities fr speticquafcction tasks. The qualification potocel shuld desenhe the folowing contents gue 6:04) [eontent and organisation ofa lifeation protocal (objective subec scope ‘Naming of peteonnel an thelr taske nthe qualia team Description othe qualification stretegy Deviations fom the company euaiistion strategy ‘peat raring ofthe components ofthe qualification Process ceszrintion {crial tacit parameters (ero the risk analysis) Document ist prval ofthe document nies Het pane Wok anes Design uaitcaton Figure 6.64 Content and ergnisation of qualifeation protocol “he teat plans with he acceptance cere consttute the predetermined speciation end ae the core ‘tement of these quaiction protocols. The acceptance cea ae defined and approved in advance and se uted to assess and eralust teat reels dung the course of qualiieation acts, The tet plane orate the detalles implementation planing forthe various coments ofthe ius! quaiation ops fire 6.65 and fig 6.6 show examples of test oan, 22‘Yu wil nd further example in chapter 812 Example: Washer, chapte 61 Examples of 0 plane end figure 62, chapter F1 Examples of 09 plans and igre 62. ‘A comparionof bath teat pln reveal tata much mote dtd desertion of whal shouldbe tested and hom a8 well asthe quay of the testing, could be specified in the Individual test pins, To avoid risunderstandinge about the type and scope af the sees, indivi object-oriented schesules must always ete prefered option “The quafetion protools may also be used to document he quaifieatin ative card ut iio the system used forthe bate production intructors batch production recor), Following implementation ofthe test plans 3 comparison withthe aceptance ete i cree out Deviations must be documented, evaluated and remedial measures taken Changes rade dung th qualficaton including the reasons for ‘these and ter evaluation, must be listed and signed, Iti therefore recommended that an itera component of a qualification protocal is runing index of changes [Test plan- "Suppliers technical documentation” [objective he atone, completeness and factual accuracy f the documentation delivered bythe suppl onthe loasie ofthe purenaterequitin are checked within the scope of he test plan Tea eaariion he document ited in Tele 1 ate ae competed with the documents prewded by the supper {actu o vey ter exstece, completeness and factual accuracy. Oevations must be documented. The cocuments must be referenced drawing number arversonspeced) and the storage location must be inccated The documents cary nspecton marks, S Reveptanes eteion Jat documents teen Table must be aval nd complete, Te documents must be checked the Jovan specialist engines to ene that they a actu covert nd must be aisle with de and bianatwe as confirmation Test inplmetation and docurentaton rable 1: Technical documentation of super fiscossry documents Pvatabie Deviations land factually loesino) Technical epecfeatons lessrotion ofthe equipment, rating stuctons Finctonal arom Peteaam cerblayout plans kpoW of eeray and tes fircucing operator parameters) Jcchoical data sheste lsrfcatee for Morcants, ade and ute Matera cencates of parts coming inv contac wih the product Wecessary documents ivaiabie [Deviations ln fectually joes) lrsronmenta condone erdeng nstratons firctuang irtevals im operatag hours) an[leaning procedure [albvaton insti and calation report for works clbraton [sdevatione Sunny he ea plan has been cared ou andthe acuracy ofthe resulshas been checked pee fe ree eteia have been files foseresne Gonna [Date/signature (implementation) ‘enters Gone) Fpwe 6.05 Example o the organisation and content ofa complex et lan [test plan 01: Technical documentation - suppliers P&l flow chart \comparion of he Pt flow hart wth the compltad equipment to very estance, complteness and fectualacewacy Cheek vel sufi labeling ofthe equpment an check fils of matt Docume to be used Psifow char drawing no late of matelesn [Test eserption he flow chart must checked against the exsting equlpment. Todo this, an Iepection mark (tok) must lbs appito equipment components onthe ow shar they have been corey etal and an, Furthermore, te bl of materi must be checked against te elstng equipment and each item onfmedinddualy wth atk The desiptons in hel of mareale must be veri iaduay. The Jequipnetidentiers drawn nthe flow chart must be attached the fay thems be conimad by lcking these ois the lew chart. The apparatu bar mus also be checked lbevations must be noted on the low chart nthe bil of mater Ine ream must be checked and assessed by lhe version umber of the documents must be entered ithe tst plan, Ihe test must omy cred out by two persons. Ihe documents must be appended tothe test pln anc th storage locaton must be spected, Accepaneeeretion he documents are avaible, complete and checked, The acy is ly labeled All deviation ieted lbeweon the documentation andthe nstaled equpment have been evaluates Ja documents have been signed by the checkers he documents are versione ra new versions sleaze by the specialist engineer responsible (Testes [ow chat aya, version 7s avilable and has boo aly chock laf nates ye, vereon 7s avalabe and fas been fly checked [i soviaions have bom evaluatesfo edatonal changes have been made othe equipment fhe eaupment scone nad |e fats uy ale |e new approved version ofthe flow chat hes been created ends avalable |e ew approved version of te ila mateala hes bees rested andisavalabl he test plan has been carted ou andthe acuracy ofthe resulshas been checked fe fe sccepance cilia have ben fulfiles Dateraigratue conto) fzrestonatut inslementaton) pure 6. Example othe organisation and cone ofan nial tst plan 6.C.3 Qualification report (nce the qualtcaton tasks are complet, the results obtained are summarised inthe quelicton report. ‘changes made tothe qulieaton protocol rt the test plane ding the @ualfaton must be desenbed Aogether ith bl explanation ofthe reasons. ‘The results of te quaiiation mustbe described 9. lla test plans were implemented before the 00, er alltest plans were succesfully concluded without changes and deviations. Devations must be described and evahated inthe report. All etal deviations that eccured within the scope of the qulicaion must be elminated before the qulficaton rept is approved. Non-ial evanons may be accepted where appropiate reasons ae provided. If vations that have not bean lnunated sl ext tig imgertant to havea acg too terwige thee ls a danger that such uveslved Ponts may be veloked Once the aualiieston report has bean successfully concleded, the equipment le tlesed for use ot validation andthe qualification statues abled according ‘he repor shoud also fonmaly adress the flowing pts na summay ‘ualicaton stats of he ecly, Maintenance pogranme, Recalaation programs Operating rsructions (SOP), Documents of ustitation, Hanelng of flue changes and reqalfeatons 6.C.4 Labelling of the qualification status once the qusficton eat has been apove te cualfcatn statu th egupment ie bed by iene olfatan mak od comment nt eure og book. euoment that has not yet been qualified or has lst quatfistionatetus shouldbe dented a ch, 9 qualification quratine. Fxaroles of thi ype of etieation ate shown gue C7 Qualified Qualification quarantine Revision: month/year Datelsignature (head of production) Datelsignature (bead of production) sizFpue 6.07 Examples of qualification status labeling 6.C.5 SOP - "Qualification of facilities and equipment" Each company should define ther own spect qualifeatn sequence In an SOP. One of many possible ction is shown onthe folowing pages feampany ame Love fpreretra procedure is0P ro te Wala rom laualiication of facilities and equipment|page xafy Feces Ieplces SOP no farang tor Purchasing Frodueton fatty conta fatty assurance Farintermationto Fampieay fprvea lcnanoe ex hiew cmpianon “Introduction Backgroundobjecives “The quafction hou very that facies and equipment sed for manufacturing and testing are stable for ther intended purposes and thatthe requires quel of the medicinal products manufactured can be uaanteed Quaiieton thus, base factor for dup product safety “The SOP describes he genera qualification procede. the rlevantrulesandrgulations FU GMP Guideline 33.4- equipment must be sutabe PS P1006 quails vatdaten and cleaning valdation ecorsmendatons Ccommigsan Okecive 81/9S6/EEC of 19 June 1997 0 define Basle prniplee and guidelines of good manufacturing pace fr mesial products fo human use, Chapel Basie principles and gudelines of 00d manufacturing practice, Atle 833. Defnton uatiteatn Documents exgence that facies ard eavement operate fulessly and aleo prose the expected resus establened Quelicaon se mul-stage process consisting af the flloning prt Design quaieation (00) wizthe requiem or faites and equipment assess inthe planing phate by the tare operate (utes regurements tly taken ito account nthe supple spectieaion echnieal Summary of al conuact ver requemertsnreltion a Scope af supply and services “Teehnicel specications Deszrton of plementation ofa user requements epecifestons). InsaltionQuaiteaton (0) Documented evidence that faces and equipment sty the requements ofthe design qualfction In ‘eso iden nstallation conformity withthe guidelines and documentation. Operational Quaifeaton (00) Documented evidence that he eqipmentfacity is funtoning eae within the species “The operational qualifications eared out without the poset Performance Qualifetion (PO) Document evidence ofthe correc interaction ofa facty nd equipment comonent with the tlevant process, This quaiieation phase is considered separately andi caried uty he ust, Person responsible for qualteaton Ns person ensues the qualification of equipment wiln his atea of responsibly. He appons @ ‘uals task coordinator end qualification teem, sn algo confirms that each quaiiation step has Qualtcatin cordinator his person coordinates the tasks ofthe qusliieton team ar also compiles qualification potecle era pons ‘Qualication eam he team members are staff who have species qualifications with regard tothe technical functions of, were computerised systems are the subject ofthe qualification have speclltqualicatens with egaré {othe relevant function, Exteel cmpeties may also be pat ofthe tear ual assurance ‘Quaticaton protocols and reports are checked to very their comslance withthe rules ofthe quality sscwranceeystem and subsequently approve. 2 implementation Procurement of the equipment tobe quads cae out by gale suppliers, prospective qualifieston must be cared ou forall new faces and equipment Exiting equlnt tat in lend n operation mut be quiedretoxpectively ach qullication Is based on sk alysis ving which the etic parameters of te fachy and the he qualfcation scope maybe confined tothe operational qualfation Inthe case of base production an nays equipment (a. metro balance) anda ick anh maybe onsite, he contents ofthe use Fequtements and teciical pecistion may be used asthe base fr the design ‘uatfeaton he technical specications describe the pupese ofthe equipment and the requirements in eaten to Construction and workmanship, Accessorie and spare pai, Costomer serve, Starting mateals ane products, sampling fe wel a ochedding and regulatory requtements, m2Changes tothe requiements are manitored by a vilorm ehange eonitl system during the process. A “The requted speiication desecbes the conversion of he equpment requirements as defines athe user “The quafeation i cared out an documented inthe aforementioned sequence, Each quafistion ep “Tain and netustion of te operating personnal cared ot a mely manne andi documented (nce the qualification hes been suecessuly completed and te equpment and faces approved by the persone responsi or quai, the handover ie madeto the user, hain tu pomdesconemation. Flow chart (See gue 6-8) Tho qualtcaton protocol contains: Pach of order bye person responstte fer quaifieston Namesof the persons responaie Responeibiies Tho object of the qualfeaton incucng scheduling Descroton ofthe equipment be qualifies and the qualiestion acivtes 4 Lstof the necessary dectons Define user requvamenss Personresparable ferquaite compile techie speclcatins ‘Gunlfeion ‘cooranater Formation of uslfeaton tor Pesonrspansile fer quaifiesion 2 —_] compile _uslifetonprotocal Guilfewion ‘courdnater ¥ felesee qualiicationprotocal fer quaitewson| an| Approve quale prewen| ual assurance Lene heck contermity technical spereatons ‘wih user requrements Parson response ‘rquilicaton TY Check canferity vith Onsen regulations ‘ual assurance Techrical OK" comple derning reing| ‘schedules Gnifeten courdnator “The esting schedules ate based onthe user requements arte technial speciation, idence of compliance wth th user requirements ans the tecnial peetiation is provided by th est nt calbration protocols “The tat end alain documents ae prpares on‘Check conformity wth ter requrements and rechncalspectcnons Peron responsble fer qualification Arorove testing schedules Gualfieton se schedules O° [= Cary outard document 13a, 10,00andPo Gasifier Coordinator oe comple Gusifeston ooedinator | check conformity documentation th Cat regulations (Quality aesrarce User eguiements Technical spec ‘uatiicaton pen & ciagrams, design drawings and bis of matenals Descrston of he eomponents Spare pan st Waning documentation SOP, drectone fr cleaning, aerating inatutons Checks required by aw uaticaton report Handover protocol Necessary decumertaton er equipment that aeady in operation ‘ualfcton pen Deserton of he technical equpmant Tani documentation Log book Checks required by aw (valiicton report, toraCompile evatication report ‘Giakestion ‘coordinator — Relene euaiication report Paronresponatle erquntication aed Chock canormity of qualtkationteportwth ‘Gh egulations| and approve aly eat ad Foxmalconfamtion ‘that qualcation work Tasbecasuecesstuly ‘conehled Rersonresponsibe forqatteation Horedover tothe rer Peron expanable Forcquatication Figure 6.8 Flow chat Revision (nce he qualification status has ben achieved this is subsequently checked and evaluates every thee to ‘ie years independent of the plementation of necessary requaltiestion meesues: the resulting measures td ress ate docueted Documentation and storage ‘nce the qualifeation report has been approves, the cuaiication status of the equipment ie Ibe by te ‘equpment used for production and tests: Deserton af the spl scope Tranng documentation 80S, dectons fr cleaning, operating instructions ‘Quaticaton report, Mantenane ad cabraton netvtons/protocols The quafcation report shoul! at as conta the folowing Names ofthe persons response Designation of the equipment LUstof measures stil o be cate ot nlading esgnation of responsblties and schedulng Insering »qualfeation mark nd comment inthe log bok own, nineammary [ne quaiiestion documentation consists of quaMieston protocol wth ecceptance cera thet have been Jsetned and approved i advance and qusflestion repr wits the euts and nel evo, Ihe quatication masterplan is a management instrument used monitor el qualiflestion activites et 2 ompny: it ist the ask to be cared out ogeter wt the esponsbltes and schedules. Ihe general sequence ised down ina qualification SOP oom Banca sve Se =