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Akorn(India) Pvt.Ltd.

(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 .

Implementation ( Last Six Month ) :


Autoclavable IPA Bottle used in Sterile Area. Double Hand Gloves Practices in Washing & Sterile Area. Revised Intensity of tube light limit in visual inspection area Garment Sterilization cycle define with numbering system. UV Light Burning hours record Using High Beam torch to ensure cleanliness of tunnel. At decartoning stage implemented the Glass Vial handling protocols . Area Restart up Procedure after Major Shut down . Filter Cleaning/Sterilization/Replacement format implemented. LOD testing for Rubber Bungs implemented . ORAB System implemented. Sterile Garments wrapping practice has implemented i.e folding the cuffs and bottom part before proceeding for sterilization . Critical check point demarcation in Packing Line . Challenge test for labeling machine before start the batch operation .
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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
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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 .

YIELD DATA OF LAST SIX MONTH BATCHES


EOPA No. PRODUCT NAME Local Sale Merocrit Baby B No. MFD B SIZE FILLING DATE AAN2001 Feb-12 05 Kg / 16.02.12 28474 Units Std. Yield ( % ) Yield (%) 25095 + 85 (C.S ) + NLT 88.93% 115 Vials ( Analysis ) 95 T. QTY PACKED Rejection Remarks 1460 Units Due to problem in vacuum in wheel port Local Sale Merocrit 1gm AAN2002 Feb-12 50 Kg / 16.02.12 35597 Units 34175 + 53 ( C.S ) + 160 Vials ( Analysis ) NLT 95 96.60% 19 Units Process validation batch

Export PH/1112/27 56 Export PH/1112/27 56 Export PH/1112/27 56

Ciplacef 250mg

AAN2003

Feb-12

20 Kg / 25.02.12 65266 Units

62740 + 37 ( C.S ) + 30 Vials ( Analysis )

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

30 Kg / 28.03.12 97728 Units

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

20 Kg / 14.04.12 17570 + 43 ( CS ) + 54 NLT 17867 Units Analysis 95

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

PH/1112/4714 Cefasyn 750mg

ADH2001

May-12

20 Kg / 24273 Units

10.05.12

23565 Vial + 48 ( Analysis ) + 26 ( CS )

NLT 95

97.38%

23 Units

Local Sale

Merocrit 1gm

ADH2002

May-12

50 Kg / 36066 Units

25.05.12

34865 + 53 ( C.S ) + 80 Analysis

NLT 95

97.04%

07 Units

Local Sale

Merocrit Baby

ADH2003

May-12

05 Kg / 29042 Units

26.05.12

28240 + 85 ( C.S ) + 115 Analysis

NLT 95

97.92%

13 Units

Local Sale

Merocrit 500mg

ADH2004

May-12

25 Kg / 36344 Units

28.05.12

35529 + 61 ( C.S ) + 136 ( S.S ) + 100 Analysis

NLT 95

98.57%

06 Units

Export / Ciplacef 1gm PH1213/0120;P H/1213/0125 ;PH/1213/0195 PH/1213/0448 Novatax 1gm

ADH2005

Jun-12

40 Kg / 31881 Units

15.06.12

10000 + 10000 + 10157 + 350 ( S.S ) + 44 ( CS ) + 04 ( RS ) + 60 Analysis 35570 + 47 (CS ) + 54 ( Analysis )

NLT 95

96.02%

19 Units

ADH2006

Jul-12

40 Kg / 36310 Units

03.07.12

NLT 95

98.24%

32 Units

Market & Depo. Complaint


Still we have no any market and Depo. Complaint for any product in Local as well as export .

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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 .
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RM/PM Issue & Action Plan


We have received the one of the consignment of rubber stopper from M/s Jamnadas , in which the rubber fiber was in observed inside the grove of rubber stopper . Discussed with M/s Jamnadas and returned back the whole consignment . Recently ( 13.07.12 ) we have received the consignment of RTU rubber stopper from M/s DATWYLER was found in damaged and wet condition . Information already provided , the decision for reject the material is still pending . There is bottom locking & pasting problem in inner carton is cont. facing ( 4-5% ) . The earlier supplier was M/s Jenus International and now from M/s Laxmi Offset . Sample along with on line rejection has send to Coordinator every time .
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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

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Type of Rejections
Types of rejection observed as :-

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Rubber stopper having rubber bur inside the grove

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