1. PHOSPHORIC ACID (SODIUM PHOSPHATE MONOBASIC) 90 ML SOL. [SOL] d%im 3,900 BOT

2. SODIUM BIPHOSPHATE 1055.55 MG+SODIUM PHOSPHATE 59.32 [SOL] d?uim 24,550 BOT

MG/ML * 118 ML ENEMA

3. ANALGESIC CREAM 30 GM (METHYL SALICYLATE>lO% [CRM] d$ulm 35,400 TUBE

4. UREA 10% 20/30/35 GM

5. POVIDONE-IODINE 500 ML SOL.

6 . CHLORHEXIDINE SCRUB 4% 5,000 ML SOL.

[CRM] e ) ' % i ~ 22,000 TUBE

[SOL] d5~1616 8,676 BOT

[SOL] d5811611 528 GAL

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1. PHOSPHORIC ACID (SODIUM PHOSPHATE MONOBASIC) 90 ML SOL. [SOL] ~?UISW 3,900 80T

2. SODIUM BIPHOSPHATE 1055.55 MG+SODIUM PHOSPHATE 59.32 [SOL] d ~ u i m 24,550 BOT

MG/ML * 118 ML ENEMA

3. ANALGESIC CREAM 30 GM (METHYL SALICYLATE>lO% [CRMI d?u?m 35,400 TUBE

+MENTHOL>5% +EUGENOL>1.3%)

4. UREA 10% 20/30/35 GM [CRM] d%.~u?m 22,000 TUBE

5. POVIDONE-IODINE 500 ML SOL. [SOL] d?uim 8,676 BOT

6. CHLORHEXIDINE SCRUB 4% 5,000 ML SOL. [SOL] d5uit.k 528 GAL

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2. dsamw afiu%qaa"uaw'ui 6 siuni=i

1. PHOSPHORIC ACID (SODIUM PHOSPHATE MONOBASIC) 90 ML SOL. [SOL]

2. SODIUM BIPHOSPHATE 1055.55 MG+SODIUM PHOSPHATE 59.32 [SOL1

MG/ML * 118 ML ENEMA

3. ANALGESIC CREAM 30 GM (METHYL SALICYLATE>lO% +MENTHOL>5% [CRMI

+EUGENOL> 1.3%)

4. UREA 10% 20/30/35 GM [CRMI

5. POVIDONE-IODINE 500 ML SOL. [SOL]

6. CHLORHEXIDINE SCRUB 4% 5,000 ML SOL. [SOL]

B. ~ a i u i o s n i s 1. nmauC2n"?d

ni~ds~onn7~~~az6aaei isui (drmadazduannnusrlni dioadaasnaisuaahodia~aio1d6

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Practices) hwuamda~ua.iioan"uuiiaaua (asJ"uiiqnmiusiluni~~~aanouInu~wanis?u~oansauwraua siniuiaaaziu~w~mui$ui~uan"udi~ui~sd"aio~usoanis"aaasiz99' ailuoeiiss.iau) bmu6oadsznoum"au

4.1) Certificate of GMP Raw Material / Active Pharmaceutical Inyredient (API) ~ ~ ? ~ n i > ? ~ " e r s ~ GMP

miuu ims~ iu GMP-PIC/S a i n PIC/S participatinq authorities v?o WHO-GMP "uadsaaww{w$m Lbaa

4.2) Certificate of GMP Finished Product i?usoamiuuiws,6iu GMP-PIC/S m?o WHO-GMP

- ~ ~ ~ ~ ~ ~ ~ I u ~ ~ E L M ~ ~ w u ; ~ ~ ' ~ x J u ~ I s ? u s B ~ GMP miu l r imstp GMP-PIVS m n d i l i n n u

nm:ns3unisoiwisaLazui wioliJunis?usoa GMP miuuinsziu GMP-PIC/S a i n PIC/S

participatiny authorities

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participating authorities

5) d l l u i h u o ~ u ~ ~ l i i u u 6 i ? u u i (UUU nu.1 win u.1) & t i i u ~ l j i u a r ~ & 1 ~ i o u s i ~ a r ~ ~ u m q l u ~ n 9 ~ l u z ~ a w 1 ~

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Analytical Procedures) ~ $ u n r ~ ~ u d ~ ~ n u m n ~ ~ u ' b e l m i u d s ~ n ~ ~ n s z ~ s a d a ~ i j ~ s ~ ~ d e r ~ z u $ i ~ i m w n , 2556 ns~~nisad$uu~adada~,n"b"~~ lsjirruud1au1n"iua~~M"~1~d~uua~elaas1un1sluwz~~uu6i?uui (a~uu wu.9)

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6 ) d i~u i61s iu i [Pharmacopoeial ~ ~ u n i s $ u n z ~ ~ u u u i 6 d ~ m q ~ ~ $ a u i d i < ~ 1mawWm5m9iuid~~58:d

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U i w.fl. 2556

7) ~ i r u i ~ ~ ~ ~ o ? u s o a n i s ? a ~ s i r w ' (Certificate of Analysis) w~ouminia~fiuua~uun"uuims~iuc.l'i?uui [Pharmacopoeia] ~ f l u n i s $ u n : ~ u u u i ~iuuar~aunudsani~nszwsa~ai~ismqu $94 rayoi is iu i

Y

w.fl. 2556 ~ d ~ m q i % ~ ~ a u i d i 8 ~ bbaawamcm.n'uial"i~?~~el ~mum"o~elsianoum"au

7.1) di~ui~~~3a?uuerso~nis~awsi:w'a"mq~u$auid~K~ (Certificate o f Analysis o f Raw Material / Active

Pharmaceutical Ingredient) ~ W U ~ O S ~ S Z ~ D P J ~ U

7.1.1) illui~sa"9~o?u"ersd ' ~ ~ d { ~ $ m ? m q ? ~ $ a ~ i d i < c (SuppUer)

7.1.2) d l ~ ~ i ~ ~ a ~ 0 ? ~ 5 0 9 91od{w~(il~8mn'~6n'uidibf0~d (Manufacturer)

7.2) di~uiwG~3a?uso~n1s"a~w~iz~w8wKmw'uidi~~il~d (Certificate o f Analysis of Finished Product)

lmunasdsanou6au

7.2.1) d i ~ u i ~ G a B ~ i U s a a 00a~w8m~8mniUduid iEo~d (Manufacturer) Iu$uniswWmdda&ndia

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wPd"s~o?u"usa~in~w8mw$mKmw'uidibf ~2di7uCu)

7.2..2) dnuiwGaflniurnd usqhurimirdu ~ i o s n i i u ~ u ~ n i n ~ a n m dj lds iu3r jn{wWnoi~~auo

slmi) &m"?unis?ersod Good Laboratory Practices (Certificate of GLP) wyo ISO/IEC 17025

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8) di~ui~onaialaflndni'a;~nvifiaiuma$a (Stability data) Fnuiosdsanou6au 8.1) Long term stability (n5;

d $ u n r ~ i i u u u i u i ~ ~ 2 u i n n i l 2 0) 8.2) Accelerated stability ~ ~ a z 8.3) In - use stability

9) ~ ~ a u ~ ~ ~ ~ ~ o ? ~ ~ ~ ~ ~ ~ m ~ ~ 6 n ' ~ l d i ~ ~ ' i l ~ d (Certificate o f Pharmaceutical Product / Certificate of Free

Sa\e) [nsi~SuuiJi~Cigli~ud~z~w~lnu] 10) di~uiaonai~uamsu"oyan~s~~funisuss~~u Green Book uos n%81?nui~iam<ni%bawnu' [ thz l

Giu"m?nvi~uui6u~auu vas diCnaiummanssunisai~i~aaarui [6ii i ]

12) di~uiw~n,biumaiuauuauadw~m~~dui (Bioequivalence) m i u ~ n m d i dil in~iumcuznssunisoivis~~aa Y

8-1 Riwum nsG~Buui!naiCic [t i i i i ]

13) ~1~uia~nn~n~s?uso~sru~qmniwIs~~iuwGm~8mfim6n'uidi~4~~d miuuim5~iu uan.9001 M?O uan.9002

I u " n n i ~ ~ ~ a r u o u 4 i u i l indi~n~iu~ims~iuw$mKmw'~mai~nssu w ~ e a n i G u ? u ~ a ~ ~ 1 i m s ~ i u ISO 1431

~lj~udiudnsrnsad?mai~ns~u~sjinis~uso~s~uuu ~ ~ ~ L $ U U I W ~ W ~ U ~ I S L L W W ' ~ M U [iiiiii 14) ~ a o t i i ~ w i o n a i u ~ ~ s ~ I u u u i ~ u s s ~ i a r ~ i w ~ i u i ) t i ~ ~ l j o u 5 w~auus5y~m.n' $ ~ ~ ~ u ~ a ~ n u ~ ~ a n ~ n i u a z ~ ~ u m

~m"msuii?umiu~ri~wunIu~a.iioqmau~~ald~i~riiu Imu l r~ i inu ibaaua ium3un i ~ l oaaau f i ~% i t i u

6aoEii~'lii inst-3m~

n798da ~ u i u i l r ~ a ~ m ~ ~ u i m i u n " i ~ ~ ~ o ~ ] i n m m ~ ~ ~ w w u ~ i a m ~ d u m a ? o u & . q n ~ ~ ~ i

ni~daamuui 1) ~uiunas~szuu~mdsuiw%~~unii?uio9 Good Distribution Practices (Certificate of GDP) bmubawi-uii

6os$miabnuiauuias1(dmaiu~~u (Cold chain system) a~az6os~m~sui l .<i d i ~ ~ s l Z v n i 3 ~ 1 b w w u i ~ i a a a u a i u ~ ~ u w f m i u < i u a u d ~ i ~ u n sl iulu 30 Yu duilina"saa~?uii$s$a

w

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1. PHOSPHORIC ACID (SODIUM PHOSPHATE MONOBASIC) 90 ML SOL.

2. SODIUM BIPHOSPHATE 1055.55 MG+SODIUM PHOSPHATE 59.32 MG/ML " 118 ML ENEMA

3. ANALGESIC CREAM 30 GM (METHYL SALICYLATE>lO% +MENTHOL>S% +EUGENOL>1.3%)

4. UREA 10% 20/30/35 GM

5. POVIDONE-IODINE 500 ML SOL.

6. CHLORHEXIDINE SCRUB 4% 5,000 ML SOL.

nuu * ~ I U ~ I L L T W

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