[BIOLOGICAL €-LWNTED ScLocies VSN I Investigation report for Deviation (PR No. 1634, Dated 09.05.14) 1. DESCRIPTION OF EVENT: In 8 No HIPPIMPY/29414 crude PRP taken 120.72 grams instead of 80 gras 4118 bate see. 2. REQUIREMENT OF PROCESS / SOP: | crude PRP with a final concentraon of NUT 5 mgimL at 16 L bath size (ie £809) sal be taken for purifeatin as per BPR SOP No. 103822. (Puiation of Hib crude PRP) 3. IMMEDIATE ACTIONS TAKEN: ‘Asstcnal ew material request indented fo the requed raw materia de to Increased ingut of PRP and to contnue the further purfcaton proce 4, IMPACTED PRODUCT AND PRODUCT IMPACTIBATCH Nos.: 5. No. HIP S34014 5. INVesTiGaTiON: 5.1Folowing ports have been recorded by applying the tol “Geneni Genbutsu ‘means (Go and See fr investigation, ‘The subjected batch was stared en 0805.14 by taking the crade PRP 120.729 (H1CRI001/12, HORISOTIS & HICR/GOB/4) neta 8D g 1+ HICR Crude PRE detalie: Table 3: HICR crude PRP detals were checked and tabulated blow. PRP contont (gil) oF _ (oD ot |aty-taken| Amount of Batch No. | concentrated crude by orinol — (mt) Pre) | | wioRAoWrs 7005 04s WCRRDTHS 187 saa | 12072 HicRaON@ 348 8 | ‘+ The PRPs estat by ocinol method in quaty canal department ‘+ Based onthe above esuts HICRII1/3, HICRIG7M3 and HCRORI4 batches were having satstactor amount of BRP fr processing HIPPIMP/34/14 batch Hence the steps involved in generation of daten No, WCRI, HICROTS and HICRISO/4 consiteed tobe eatstactory.Investigation report for Deviation {PR No. 1634, Dated 09.05.14) S41 Mater: Table: Al he raw matefal used fr te proces are veiled and given in eon tae Sie — Raw atoat Nome | —AR Ne — TG] Ros) Sreosem naaet = i restate acne | PM/9O5H0 | 06 Son anyones 2 soon, |_Runanwr | 2 [nA ‘any tra os 2 | fader Runiaoos7 | 440 0, + | sosmenore — | pyngance FEE] me : x. | Rraea0s [_se0 | wa ‘Secon acetate hyerate | Rawyi3/0228 [3000 cy 3 a 7 a a Sega | Rinaoi | Too | tm @ siunotse | wisoors | vera | na] z as RaN30«6S |" wo | Prvmraseme mes | rwiaoa7s | 1.64 | na 1_[-— Sem eartnats | ~RWEaOTO? [1500 | wa a eer ngs | ¥z2 | NA Trl 2: iter eae [Be Filter iD No. ‘PART No. Preintegrity | Post integrity [ot [pans07 | rear ee ma Pass ‘The MOC of the iter used (Make: 3M) PES and he fier used was as pr the ‘BPR instruction and ne cscrepancy cbserved dung PRP fiat,[ BIOLOGICAL €-cTED [icxocics pvision Ss Investigation report for Deviation (PR No, 1634, Dated 09.05.14) 5:12 Method ‘As part of investizatin the total puieation step daa is investigated and is 8 flows. Process flow onan 00 pm AJB) [A i