KVALIFIKACIJA DOBAVLJAČA/KUPACA. Snežana Tvrdorijeka Direktor sektora kvaliteta,
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1 KVALIFIKACIJA DOBAVLJAČA/KUPACA Snežana Tvrdorijeka Direktor sektora kvaliteta,
2 SADRŢAJ Zahtevi regulative Tipovi dobavljača Standardi po kojima se vrši provera dobavljača Tok kvalifikacije dobavljača Odobravanje fokus na tip proveravane strane Zaključak 2
3 ZAHTEVI REGULATIVE Volume 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use, Part 1- Chapter 5 jasno propisuje sledeće zahteve: Selekciju Kvalifikaciju Odobravanje i Održavanje dobavljača polaznih materijala. Nivo supervizije dobavljača zavisi i od same kompleksnosti materijala koji proizvode, rizika kojim su izloženi polazni materijali, lanca distribucije i na kraju od namene materijala koji se isporučuje. 3
4 TIPOVI DOBAVLJAČA Dobavljači API (gde god je moguće, polazne materijale treba nabavljati direktno od proizvođača). Dobavljači pomoćnih supstanci Dobavljači primarnog i sekundarnog pakovnog materijala Distributeri U zavisnosti od tipa dobavljača provera se radi u odnosu na zahtevani standard za tip proizvodnje. Osoblje koje obavlja ove aktivnosti mora imati adekvatno znanje o procesima koje proverava, kao i o svim mogućim rizicima 4
5 STANDARDI PO KOJIMA SE VRŠE PROVERE API i pomoćne supstance - EU GMP standard Primarni i sekundarni pakovni materijal - ISO 9001:2008, Opciono: ISO 15378:2001 GMP za pakovne materijale PS 9000 : 2001 Pharmaceutical Packaging Materials (sa zahtevima GMP) Distributeri - u zavisnosti od toga šta je predmet distribucije - GDP/ ISO 9001:2008 Proveru vrši: Korporacija Lokalni tim 3rd party Auditor mora da bude odgovarajuće edukacije, sertifikacije i iskustva 5
6 PROCES KVALIFIKACIJE DOBAVLJAČA Evaluacija Provera(audit) Odobravanje Monitoring Nabavka materijala Sertifikacija 6
7 TOK KVALIFIKACIJE DOBAVLJAČA- EVALUACIJA Provera informacija o kvalitetu materijala pre kupovine istog (nabavka 3 različite probne serije i kompletna testiranja materijala) Evaluacija proizvodjača -sertifikati -lanac snabdevanja -transport -skladištenje Evaluacija materijala Nabavka tri serije API- testiranje Pisanje evaluacionog izveštaja ukoliko je sve u granicama specifikacije 7
8 TOK KVALIFIKACIJE DOBAVLJAČA AUDIT Korak I Najava provere proveravanoj strani 30 dana pre predloženog datuma provere Korak II Priprema Agende (plana provere) i slanje proveravanoj strani 4 nedelje pre dana provere Korak III Izvođenje provere po unapred pripremljenom planu Korak IV Priprema liste observacija Korak V Definisanje korektivnih i preventivnih mera sa rokovima od strane proveravane strane Korak VI Pregled i prihvatanje ili zahtevanje dodatnih mera na odgovor proveravane strane Korak VII Monitoring izvršenja predloženih mera Korak VIII Monitoring proveravane strane redovni na 1 ili 3 godine u zavisnosti od observacija koje su utvrđene prilikom prethodne provere, ponovna provera u slučaju veće reklamacije. 8
9 ODOBRAVANJA FOKUS NA TIP PROVERAVANE STRANE Ukoliko nalaz provere pokaže kritičnu neusaglašenost-dobavljač ne može biti odobren. Ukoliko nalaz pokaže veće i manje neusaglašenosti, dobavljača je moguće odobriti pod odredjenim uslovima. Odobravanje dobavljača sledi nakon prihvatanja CAPA od strane auditora. Zahtevi su isti za sve vrste dobavljača/proizvodjača API Pomoćne supstance Distributeri/posrednici 9
10 TOK KVALIFIKACIJE DOBAVLJAČA - ODOBRAVANJE Dokumentovana uspešna kvalifikacija je prvi korak u odobravanju dobavljača. Nakon potvrde da materijal ispunjava sve zahteve, podnosi se varijacija. Odobravanje varijacije od strane relevantnih organa Stavljanje na listu odobrenih dobavljača 10
11 TOK KVALIFIKACIJE DOBAVLJAČA - SERTIFIKACIJA/MONITORING Mogućnost redukovanog testiranja ili uzorkovanja za odredjene materijale odobrenog dobavljača. Uključuje potvrdu uspešne kvalifikacije dobavljača za date materijale Periodično se proverava status proizvodjača Periodični pregled reklamacija/oosova, neusaglašenosti Razmatranje od strane rukovodstva na odboru za kvalitet Status odobrenog dobavljača se može izgubiti, ukoliko dobavljač ne ispunjava zahteve. 11
12 Dosadašnja iskustva Rezultati provere distributera Odobreni Uslovno odobreni Odbijeni - Početak 2014 (90% provera završeno u toke ove godine) - U 2015-oj završena provera svih dobavljača/distributera Provere rađene u odnosu na ISO 9001:2008 i smernicama GDP 25% 17% 58% Najčešće neusaglašenosti - odsustvo standarda, - neadekvatna vozila bez mogućnosti kondicioniranja vazduha i monitoringa, - neadekvatan skladišni prostor nemogućnost kondicioniranja vazduha i monitoringa, odsustvo sistema za praćenje i kontrolu skladišta, neadekvatni objekti. 12
13 ZAKLJUČAK NEMA KVALIFIKOVANIH DOBAVLJAČA NEMA PROIZVODNJE 13
14 14 HVALA NA PAŢNJI! PITANJA?
15
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