(Date : 14/07/2012)
Page : 1
Summary :
M/s Akorn India Pvt. Ltd. ( Formerly M/s Kilitch Drugs ) was started at Poanta Sahib in the year 2006. This plant is designed for the manufacture of small volume Parenterals like Vials, Ampoules, Dry syrup ,Tablet ,Capsule and ready mix . Products manufactured in M/s Akorn India Pvt. Ltd. have been exported to several countries like Algeria, Burundi, Cameroon, Ghana, Iraq, Nigeria, Russia, Senegal, Sri Lanka, Nigeria, Ethiopia, Yemen, Sudan, Tanzania, Uganda. M/s Akorn India Pvt. Ltd. , presently have two separate block, General and Cephalosporin block in Unit I and there is two separate block for Hormone Inj. & Carba penem in Unit II M/s Kilitch Drugs (I) Ltd. sold its PAONTA Sahib pharmaceutical plant in Himachal Pradesh to US based Akorn Inc for Rs 188 Crore . M/s Akorn India Pvt. Ltd. Officially take over from 1st March 2012. M/s Akorn has taken the WHO GMP certificate for Cepha & General block . Carba penem and Harmone block under processing for certificate . Akorn India is manufacturing Artesuanate Inj. for Zydus Cadila and : 4 Page
Cont.
Carba penem block has been ready for Production. All the media fill ( Cons. Three nos ) results is complies . Hormone Inj. Block also ready for production . Equipments qualification is now completed . Production for Abbott India Pvt. Ltd. & Alfachem is cont. Validation batches in Harmone Inj. For M/s Abbott is completed under supervision of Mr. Agashiwala Documents and SOP,S under updating in the name of M/s Akorn India . Carba penem block audit for M/s Baxter , M/s Ranbaxy Ltd. Is complies . Production still not confirm .
Cont.
Breading type of seal for costly product like :- Meropenem at unit . Colour coding sticker for sterile product as per molecule wise on container . Implementation of Autoclavable paper and pen to work online during filling by unit itself . Revised the pattern load of Autoclave i.e initially mopper using for Cleaning was not given in pattern load .
Line Details :
GENERAL BLOCK
AMPOULE LINE (General Block): One Ampoule Lines are available at Akorn Drugs. The major products manufactured in Ampoule line are Canacord ,Diazopalm and Tramajek. Akorn manufactures products for Abbott and Cadila VIAL LINE (General Block): Three Vial Lines are available at Akorn India. Line I is dedicated for the Amikacin sulphate products. The major products manufactured in Line I are Alphacem ,Lamika ,Amikacin ,Laniate etc. Akorn manufactures various products for Ranbaxy, Zuventus ,IPCA & Sandoz 2nd Vial Line is dedicated for the Gentamycin Suphate as well as Artisunate products. The major products manufactured in Line II are Ranbiotic ,Falcigo ,Falcinil , etc. Kilitch manufactures various products for Ranbaxy, Zuventus & Cadila etc. Same is used for the Pentaparazole ( Antiacid ) products. The major products manufactured in is Pansa & Kilitch manufactures the products for Zuventus only
Page : 6
Cont.
Cephalosporin Block Dry Injectable Line (Cepha ): There are two lines for dry injection of Cephalosporin as well as Penem product ( Common ) . The major product are Oframax ,Zostum ,Zetri,C-tri ,Oncef ,Ciplacef ,Oframax Forte, C-Dime , Sudopem , Meromate , Merojet , Merocrit , Cilanem etc. The major client are Ranbaxy , Zuventus , Emcure , Microlab , Baxter India Sandoz as well Cipla etc. Liq. & Solid Oral Line : There are four lines for oral products like Tablet ,capsule , Liq. Syrup ( Ready Mix ) & Dry syrup . Still now no production in that area . As initially location has manufactured the oral product for M/s Ranbaxy and self marketing only .
Cont.
CARBAPENEM & HARMONE BLOCK Carbapenem Block : There is only single compact line for Liq. As well as dry powder line both . Media fill is completed for the line . Production decision under management . Harmone Block : There is two line one for ampoule and one for Vial . The plant is ready for production . Documents are complies for the block .
Ciplacef 250mg
AAN2003
Feb-12
NLT 95
96.23%
14 Units
Ciplacef 250mg
AAN2004
Feb-12
10 Kg / 32531Units
24.02.12
11020 + 37 ( C.S. ) + NLT 30 Vials ( Analysis ) + 95 19280 + 574 ( Stability sample ) 80720 + 43 ( C.S ) + NLT 30 Vias ( Analysis ) + 95
95.21%
16 Units
Ciplacef 250mg
AAN2005
Mar-12
Qty. in WIP
Export PH/1112/47 14
Novatax 500mg
AAN2006
Apr-12
20Kg / 14.04.12 33940 + 43 ( CS ) + NLT 35757 Units 100 Vials ( Analysis ) + 95 847 Vials ( Stability )
97.68%
13 Units
Export PH/1112/47 14
Novatax 1gm
AAN2007
Apr-12
98.88%
16 Units
Cont.
Export Novatax 1gm PH/1112/4714 & 4758 & PH/1213/0448 Local Sale Merocrit Baby AAN2008 Apr-12 100 Kg / 89732 Units 16.04.12 32430 + 50000 + 47( CS ) + 54 Analysis + 5426 ( Part - II ) 26919 + 85 (CS ) + 115 Analysis NLT 95 98.02% 16 Units AAN2009 Apr-12 5 Kg / 28788 Units 23.04.12 NLT 95 94.20% 09 Units Local Sale Merocrit 250mg AAN2010 Apr-12 10 Kg / 28807 Units 24.04.12 27310 + 74( CS ) + 160 Analysis NLT 95 95.61% 14 Units Process validation
ADH2001
May-12
20 Kg / 24273 Units
10.05.12
NLT 95
97.38%
23 Units
Local Sale
Merocrit 1gm
ADH2002
May-12
50 Kg / 36066 Units
25.05.12
NLT 95
97.04%
07 Units
Local Sale
Merocrit Baby
ADH2003
May-12
05 Kg / 29042 Units
26.05.12
NLT 95
97.92%
13 Units
Local Sale
Merocrit 500mg
ADH2004
May-12
25 Kg / 36344 Units
28.05.12
NLT 95
98.57%
06 Units
ADH2005
Jun-12
40 Kg / 31881 Units
15.06.12
NLT 95
96.02%
19 Units
ADH2006
Jul-12
40 Kg / 36310 Units
03.07.12
NLT 95
98.24%
32 Units
11
Improvements
On line monitoring for weight variation in product as well as the rejection details in filling area . Collected the visual inspected vials in crates with stand by position to avoid any broken . Avoided the cleaning of vials in clubbing nature i.e implemented the procedure to clean each an every vial with dry mopper before labeling . Implemented to store the inner carton and leaflet sample from each box ( 5 nos ) as per box no. along with batch record . Implemented the procedure to check the intactness of RTU rubber stopper for dispensing .
12
Rejection in Vials
There is common issue of Flip off seal mould defect observed cont. with product . Item Code :- 6000A Item :- Flip off seal Qty. Received :- 40000 Nos Supplier :- Auto fit Packaging Rec. Date :- 05.06.2012 D.C. No. :- 00313 / 28.05.12 P.O. No. :- 007550/BL
14
Type of Rejections
Types of rejection observed as :-
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16