Roll No-a\lex ; ber, ehelver ie a DikFovental Assignment ani im How con a organization effectvely integrate quality donbol_measdres into tts manufacturing process to rminimi2é defect and ensure _consislent ~ product duality? The pharmaceechcal organization can effectively integrate quality eonlrel measuye 1 emphasizing the rregquleclemy and safety aspect by Followng, way: Shingnent Regulatory cornpliance COMP. focus) Good roo huctachusing pratice Camp hevece to Grip _quideline iS Paramount This include _documerrfecton + validatton saintlance »persehhe) *- Haining and mer Regutackoy Audtts: od 4 Reguiocteyy auidris-by requiatory bodies C@q> FDA, EMA) ore essenttal organization must be prepared far these _|nspectrons change _conhol- Any chonges te manufacturing proces» equipment ex Imecksial muct be scgotously documenta ass Essfedl for xisk < approved by sequlateny affairc: Paw matenial ond supplion qnatificodion: Cemphasts on Htraceabl thy) het Suppliey audits ond qualifimtton. Suppliers of apys and excipfent! mustbe vigrously auditec| anol qualilred. centfficate of Analysis CCoAD fequire _delailed. Cops frops Suppliers .werifyrna the FOR EDUCATIONAL USE~ | identrhy panty and polency of moder ais =| | Palmtcuin enna -fraceabili ty of au etl materials iid Traceability: 2 “ \ fiom source _-fto fined product. WD | Vendor manged Envente (uMZ) tt quality Ratce 5 wents- Fusmead quality agreement with supliers cectining vesponsibr [Hs + regard ing quality . ED _| Jn ~process quality corstrel] focus cn valtdatfon and _MenHexing 3 [Process validocHon= valtdecte al] pranufackwing procece-fo _encuve they onsisenHy produce produchom of Phe yequi ned Qualtty iD Envitnomentad Monitoring Conbrol ahd monrty_envitnomental conditen. itl “In ~ process _+resting- conduct freq uent_in~process testing fo noon ftey cont parameters _Cexg: pH. piscosthy, assay) yy Clean-dn- place _CcaP> and. steniltzation - yn ~place- Valfdete lane moniter c¥P and SIP processes fr equipment Cleariliness- calibration and paintaiqnee- ReguiaY colibraten and mointainence at equipment lyre essential. iw Fina) product tetHing and release Cfocus on adenirty purity. potency and safety ) OJA TIONERS FOR EDUCATIONAL USEDae H CLDg Adentity -lesting - cenfirm the purity testing - identity of APE and other jngiedients Chsuve the product io free fj 4 A M\nants- {toro impwittes and conlca Ww 7 « febency esting ~ Verify the concenhation of API. 1SSolucH on ‘testing - Assess the rake atwhich “the drug dissolves , 2 | stability 4esting- ualuate fhe produd© ababiliky S___llander various shrage cond Hon ~ VO Hsteaility esting —_C-for_ctenile product) _ Ensuve the productis fvee trom viable micio-orqanism Vt Tendotoxin Jecting- : ‘Tes! for bacleniol endotoxins YI Quality mangement sustern Cems) and dese “Integri by » compater susten validahon csv) Validecte all competes system used in manufacturiha 7 and quality control. “blotter I ntegrity~ Ehsure the accyyracy + completences_and reli abt lity of all date. ~ Ww Document contro r Implement of document control _syslem +o manage Sops .batch yecotds. and other document. iv) || Devioction_mangement~ : Tnvestigacte and document ciny devi ak on from sop's ov specificah ons. ATIONERS FOR EDUCATIONAL USE.WD IL cArPA CcorrecHive and preventive action) “dmplement cap —te address quality [suses & [prevent Yecury ence: wD Annual prectucl_yeview C APRD conduct vegulay APR’s -fo evaluate Produc < cqucltty arél cents avea fev _jmptovement. Na os Og a OOJA FOR EDUCATIONAL USE ATIONERS