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gdk{|+R-NvQ[ir((uv0gOHQvir((W,{NSv`Q NۏLKmՋ0 Ǐ[ Clean company @b gYۏLgOW`Qċ[T NuN20*NgOW`Q0 ُ'Y'Y0W\Nl ggOW`Qċ0O`Q Nv[E55O0FO/f _NYN6*N ُR_~NNfYvnmR{| N/fkN*NYUSCQt`HhO06q bvnmel(uN@b g{|+RvNT0 N, gOW`Qċ0OO9hncċ0Ov~g \nmyv@bmSv@b gireۏLOHQz^cR0^gbLTv̀ofg [8hT D(WeHhbbJTKNT0 c) ͑eċ0O gOW`Qċ0O_N gSf0Ygċ0OvagNSuSS HN1\ۏL͑eċ0O0N N`QۏL͑eċ0O nmelSuSf ]zSuSS NTSfbmReNT YfbcbmReY ͑eċ0ONT ^ gNNck_vSceN SbNNgOW`QRh NS@b gvire/Y/elv~g T͑eċ0OKNMRvgOW`QcR0 7.0 kYuϑnx[ 7.1 {N ,gzc[YUO9hnc[eo?eBl[1]0Rgv[EBl[2]T~ nx[nmǏvY NvkYuϑ0 ,gzSb[nmRgSS7helvwQSOBl0v^~QNfYsQNS7helvOP[ NS[Rgelv^0dkY ؏cPNQy[ϑkYuϑvlQ_0 tNScShQ(Mper)/fN*N~{_Qvpef:yW~jVY GC HPLC 0[Nċ0OhKmPLOD 30R2:1KNvOjVkN,:N/fSNcSv ScS[ϑPvyrkkO/f101(LOQ)0S/Ne(WS_vS7hp N0nm[bT Rglx^valg`Q0te*NYvalg`QSNǏlx^valg`Q ce{Qeg0[N[ϑ SNHQdblx^ 6qTRg0 7.4 Rgel NUONyS7hel,{29u7.3 RyQegv7hT_{(uS_vRgelۏLRgY HPLC, GC, TLC, r^qkYu TOC UV n[ [5u'` Ph 0Y,{24u7.2cvel ǏS_vegU_elv(u'`0 YgT SN\Rgel~T0kY 7hTnBRQ(uvQNelYHPLC Rgr^qkYuirSNR:_g~RglelvOea^1060bO(uYyelY n[ HPLC SNO@bvN^\'`0 8.0 nmeHh wIN (): ________________________ eg:______ Y8hN (): ________________________ eg:______ [8hN (): ________________________ eg:______ [8hN (): ________________________ eg:______ [8hN (): ________________________ eg:______ v: eHhS___________________________________________ eHh~{Seg_______________________________________ vsQnmSOPN~{SS_____________________________ vU_ 8.1 ̀of 8.2 vv 8.3 V 8.4 L# 8.5 S7hĉ z 8.6 hKmĉ z 8.7 ScShQ 8.8 OP] 8.1 ̀of R][NTY (bNT~*)T 9hnc z^XXX [YXۏLe8^nm...... *If group of products describe rational for chosing this grouping strategy. cY nmel nmBR 8.2 vv ُyxvzvvv/ff Yg cgq[INvnmelegnmY (WYN NMRNTkYuϑ;`/f(W^zvScShQVQ0 8.3 V k!knmTvKmbSf[ċ0OYNfNTkYuϑ;m'`bN -NSOT/bKb_BR TnmBRkYuϑ]z-NO(uvnBRdY (WScSVQ0 9hncdkeHh hKmTċ0OZ*ޏ~nm*Z:N, N!kޏ~nm/fScSv 6q lQS_{nx[dkd\OvpeϑEQR v N*N7hTegfYvnm^0 :NNfnm z^v gHe'` @b g(Wxvz-N_0Rvpenc_{(W,geHhv,{8.7Q@bcvcShQQ0 fNbbJTċ0O_pencT$RenmǏ zv gHe'`0 (WfnxcfY]~ cgq]zlySOP,{AAASN蕗_w/fYnmMR(b(Ws:W gcv|~egOY NO(u) 勾YN[ N(ueguNvQ[NT0 8.4 L# [b,gxvzv gsQL#Y N(>NO) e z[cuNb/g0QA0QCT] z YnmuNb/g S7hQA 7hThKmQC penc[8hTybQ uNb/g QC QA 8.5 S7h z^ cWS,{29u7.3-N ~fNYgNY-NlydbTmm7hT0 db7hT DNYS7hVُ[NnZi0WcfS7hMO/f͑v dbS7h^S_9hncdb z^SOP,{BBBSegۏL(Ygl gSOP _{ ge,gf[QAS7hXTvb/gBl)0 dbS7hMOnY N NTkYu7hTQf7hTMOnSS nmBR7hTQfS7hMOnTS S7hp^/fY-Nv g]p _N1\/fgnmp Ygnm NEQR Y-NSkYuNT0^yf[0t'`0W bS7hp0 mm7hT ^9hncSOPCCC, Smm7hTbYgl gSOP cQANXTvS7hǏ z 0^~ĉ[mmYvmSOSOymSOSOy_{Yvc执NTvYv@b ghb 0eHh^ĉ[mm7hTvSOy0(Wh1-N ^S_@b g7hTdbNmm v~De06q \7hTQChKm0NUOvsQv7hTlyagNla0 8.6 hKmĉ z mm7hTvhKmyv g - 9hncRgeHh hKmNTkYu - 9hncRgeHh hKmnmBRkYu0 db7hTvhKmyv g -9hncRgel hKmNTkYu - 9hncRgel hKmnmBRkYu0 U_hKmv[ϑThKmP^NS%V6es0 RgeHh-N^SbNy{\7hT-NvkYuϑb{b100%0Y YgRg~gfO(udb/mmel S g50%v;m'`/nmՋBRV6e HNk*N7hTV6ev;m'`/nmՋBRvϑ^XNN2N_0R100%0 @b g_vpenc^D(WeNTbv^S0R nx[ScShQv{T&{T`Q 0 8.7 ScShQ %_{ cgqĉ zXXX vKmhgT8h[Yvnm^: vKmYnm^ ~{W[(Kb~{)_______ eg_______ nxQA : ______ eg_______ %~fNTTnmBRkYuvdb/mm7hTScShQNS_(uvpencvOnc0  N TNNTkYuϑ nmTvY̑ N gNUO+Tϑ4ls^vmmBRb(ugؚupOe^Rgelv~g^8^NO 0mmBR NSNuN]z S/fONnm0@bNnmBRfNnd0&TR ^ (uvQNmmBR0 S,gcWSv,{5z{ScShQvOP[0 SY ^~Q7hT{fte*NYv;m'`bR/nmBRvkYu4ls^/fYUO~{v0 laNy { 8h[TR_ch@b gċ0OǏYvhbbySN(WeHh-NceQVGrfS7hp/fcknxv 0 gOW`Q7h,gkYueL vrQ N SNǑ(u Tekire>eL0 3: nmT yhKm4ls^ ^: ,{8.6z O N T`Q [0xQWvZPl/f lQS[evKmhKm 9hncBlSmm7h,g0 nm[bT Ny gHev yf[v b,gNOvvcnmv gHe'`velY N@b:y 1.)vKmYvnm^0S gvKm~gnaT MbۏL NNek0 2.)SmmT/bdb7hT8^BlSNlQGSvmmmSO 0 3.)O(uelSN \pt-Nv500ml7hTr^ Kmr^qkYu0ُ*Nhel NFOve:gv ]wb*gw g:gNT_NKm[;`vkYuϑ0[Npr^Y ُyhKmSN_eu0V:Nُy`Q N APIb-NSOv~^kؚ N,l goRNT MirI{ub0 4.)Yg~g&{Tĉf:y/fYnmvKNMR /f&TSN~~O(uvnm z^ ^o?eS_@\ NcSُ7hve_0 7: lQS/f&TnmMRvYAQOcvge ^:lQS^ gSOPĉ[ uN~_gT^zsSgbLnm0ُyyr[`Q^~Ǐ06q Yg1uNgySV NzsSgbLnm lQS^Qew[Y Nlmvirevq_T0_NS R~ b R{| NT v^gOW`Q0 8:lQS/f&T g_YnmT0RO(uMRvg'Ye ^:lQS^ gSOPOY(WnmT_0REQROb NSNUOalg YOYhQbv 2\I{0 YglQS:N YnmT galgvΘi QُNΘi0  9: YgY N~8^O(u /f&T g_^znmveV ^: S[8v^0 10: +g!k(u4lmmT AQvgne:NY\ ^:YnmT Y N&^4l>en0V:Nnm z^vgTNekSb(unBRpr^b.llQm VdkO N g_uirnuv:gO0 11:/f&TS1uNY@weǏS SSuSOW VdkSegvv~g1\eHeN ^: 6R /Sf[LNYvPgevhQ_ؚ06q ^ċ0OO(uvYPgev(u'`0^Q[nm gq_TvNUOV }TYhb||vS'`0 (WT \O:Nُ*NǏ zvNN lQS^S_O(unxel[Rg_0RpencۏLvc0  12: YglQSǏgOW`QR~bR{| /f&T g_ z}Y vgOW`Q ^:(W~NTR{|Tnx[vgOW`Qe lQS^nx[vgOW`Q/f&TTe8^uN01uNd\OSV [NgNNT N*NBl z[ vnmSf gvY0  13:[Nl gM㉧NirvN(uf /f&T ^: ,{7.0z lQS^S_USrQkNy`Qv^/f&TX[(W\o(Walg0(W Nv`Q N vQS N06q ^S_QhQbnmMRvЏL!kpe0  14:/f&Tnm^S_\O:N_SyvvN*NN ^: ICHl gBl(W_S6k[enm FO^S_Q NR (W_SNTO(uFUN6R (uYT~Ǐnm (W͑eO(uMRp`S_8h[Yvnm^/f_v0 S_NTSb gFUNNeLKmՋelvk N0  17: /f&T(Wdb7hTTmm7hTybQKNT MbO(uYuN (Wnmhxvzg ^I{@b gRvhKm[bKNT Q>eLY(uNۏNekO(uYghKm1Y% gRgbLg 0e8^d\O-N[bT Yv>eLSQNhKmv~g8h[ hKmvvcr` 0lQSQ萔^勚[INO(u*g>eLYv#NTagN0 10.0 References SfNv Bracketing and Worst Case Rating R{|TgOW`Qċ0O 1. USP 24, The United States Pharmacopoeia, United States Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852. 2. Casarett and Doull; .Toxicology - The Basic Science of Poisons.; Macmillan Publishing Co, Inc. New York, Ed.2; 1980. 3. William E. Hall, Ph.D., Hall & Associates, Validation of Cleaning Processes for Bulk Pharmaceutical Chemical Processes, Journal of Validation Technology. Determination of the Amount of Residue kYuϑnx[ 1. PIC PH I/96, in .Pharm. Ind. 58, Nr. 4 (1996); Draft API GMP Guide, PIC, Geneva September .97; Guide to Inspections Validation of Cleaning Processes, FDA, 93; Draft Guidance for Industry Manufacturing, Processing, or Holding API, FDA, April 98. 2. Validation of Analytical Procedures: Q2A, Definitions and Terminology, ICH, October 1994; Q2B, Methodology, ICH, November 1996. Validation Questions  1. Cleaning Validation in Active Pharmaceutical Ingredient Manufacturing Plants, CEFIC-APIC, September 6, 1999. 11.0 Glossary /g AiArea for the tested piece of equipment # i. @bhKmv,{iSYNby0COTrue (measured) total quantity of substance (possible carryover) on the cleaned surface in contact with the product, calculated from results of swab tests. 1udbhKm{Qv mQv0NNTc扄vYhb N gyir(S&^eQv vw[~ǏKmϑ ;`peϑ0CONCConcentration (kg/kg or ppm) of  previous substance in the next batch. Based on MACO calculated from therapeutic doses and/or tox data.  MR ir((WT~yb!k-NvSm^(kg/kgbppm)01uluBRϑT/bktpenc{Qg'YAQ&^eQϑMACO 6qT{Qalgir(vScSSm^LD50Lethal Dose 50 in g/kg animal. The identification of the animal (mouse, rat etc.) and the way of entry (IV, oral etc.) is important. Ng/kgϑvRir{kϑ500͑v/fRir+R('Y 0\ I{)T~oe_(Y 0S gI{)0LODLimit of detection. g\hKmP^0LOQLimit of quantification. g\[ϑP^0miQuantity, in (g/dm2, for each swab per area of swabbed surface (normally 1 dm2) USMOdbbyQvN!kdbvpeϑ N(g/dm2 0MACOMaximum Allowable Carryover: acceptable transferred amount from the investigated product ( previous ) g'YAQ&^eQϑxvzvNT MR ir( vScSlyϑMACOppmMaximum Allowable Carryover: acceptable transferred amount from the investigated product ( previous ). Calculated from general ppm limit. g'YAQ&^eQϑxvzNT( MRNT previous )vScSlyϑ01uN,P^ppm{_Qv0MAXCONCGeneral limit for maximum allowed concentration (kg/kg or ppm) of  previous substance in the next batch.  MR ir((WT~yb!k-Nvg'YAQSm^vN,P^(kg/kgbppm)0MBSMinimum batch size for the next product(s) (where MACO can end up). T~NTg\vybϑ(g'YAQ&^eQv~g)0NOELNo Observable Effect Level ef>fq_T4ls^0Rinsing cycle mm_sSometimes rinsing cycles/runs may follow the washing cycles. The rinsing cycles may be part of the routine cleaning procedure (e.g. to rinse out the washing solvent) or may be used for sampling purposes (e.g. rinsing with water after washing with detergents). Rinsing cycles that are not part of the routine cleaning procedure may be used for enhanced sampling during the cleaning validation exercise. gemm_s/ЏLS(Wnm_sT0mm_sS/fe8^nm z^vvN*NN(OY mmcnmnBR) b(WS7h-NO(u(OY (W(ummBRnmT(u4lmm)0mm_s N/fe8^nm z^vN*NN SN(Wnmd\O-NR:_S7h0SFSafety factor. [hQVP[0SrelRelative standard deviation, coefficient of variation. v[hQOP] S_Vpe0TDDnextStandard therapeutic dose of the daily dose for the next product T~NTvlukeoϑ0TDDperviousStandard therapeutic dose of the investigated product (in the same dosage form as TDDnext) xvzNTvhQlukeoϑ(NTDDnextv TBRW)Washing cycleUsually the API equipment will be washed through with several portions of solvent one after the other by the same repeated process. One cleaning process repetition with one of these portions is termed washing cycle (run). 8^SeoYǏQynBRN*NcN*N0W(uv Tv͑ YǏ znm0͑ YۏLN*NnmǏ zy:Nnm_s(ЏL)012.0 Copyright and Disclaimer All documents and information contained in this guidance document are the property of the Active Pharmaceutical Ingredients Committee. Users of this document may use information contained therein only for personal use. No other use, including reproduction, retransmission or editing, may be made without the prior written permission of the Active Pharmaceutical Ingredients Committee*. @b geNN,gcWSeN-NOo`/fSeoYXTOv"N0,geN(u7bSN\O:N*NNO(u(WdkvOo`0(WNMRl g_0RSeoYXTO*vfNbybQ N(uNvQ[ Sb Y6R0ldbv(u0 We have tried to make the information on or linked to this paper as accurate and useful as possible. 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