WELCOME TO 06/05/2016

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1 WELCOME TO 1

2 BRASSICA PHARMA PVT. LTD 2

3 Brassica Pharma Pvt. Ltd. Factory :- Plot No. T-68, M.I.D.C., Tarapur, Boisar, Dist. Palghar Maharashtra, India Tel.: / Head Office : , 7 th Floor, Vastubh Apartment, Off Road to Carter No. 1, Near Datta Pada Subway, Borivali (East), Mumbai Tel.: Fax: brasicapharma@gmail.com Website : 3

4 ABOUT US The company Brassica Pharma. Pvt.Ltd., is a professionally managed contract manufacturing pharmaceutical organization known for manufacturing of high quality healthcare products. The facility is WHO GMP approved in following dosage forms. 1. Liquid orals. 2. Sterile Ointments. 3. Topical preparations like ointment, creams, lotions, gels & liquids. 4

5 VISION Our vision is to be a leading pharmaceutical company in India and to become a significant global player by providing high quality, affordable and innovative solutions in medicine. 5

6 QUALITY POLICY The AIM and PURPOSE of Brassica Pharma Pvt. Ltd. is to manufacture quality medicines of International standard which can be made available to local as well as International customers at an affordable price. 6

7 PRODUCT PROFILE Liquid Orals. Sterile Ophthalmic Ointment. Topical. Liquid Externals. 7

8 THERAPEUTIC CATEGORIES Tonics Antipyretics Antihistamines Antibiotics Analgesics Liver Tonics Dermal Preparations 8

9 EXPORTS ETHIOPIA NIGERIA RUSSIA GHANA LIBYA ANGOLA PHILLIPINES TURKMENISTAN 9

10 MAJOR CLIENTS DOMESTIC MARKET: M/S AJANTA PHARMA. M/S BHARAT SERUMS& VACCINES LTD M/S CIPLA LTD. M/S CENTAUR PHARMACEUTICALS PVT. LTD M/S F D C LTD. M/S GROUP PHARMACEUTICAL LTD M/S INDOCO REMENDIES LTD. M/S SIGMA LABORATORY. INTERNATIONAL MARKET: M/S WEST PHARMA TRADING PLC (Ethiopia ) M/S BHARAT SERUMS& VACCINES LTD.(Philippines) M/S CIPLA LTD. M/S SIGMA LABORATORIES, ( CIS countries) M/S PRAWIL LABORATORIES, ( Australia, UK, Africa) M/S AJANTA PHARMA. M/S GEPACH INTERNATIONAL (Russia) M/S LYKA LABS LTD.(Venezuala)) 10 M/S

11 LICENCE & REGULATORY APPROVALS Facility Approval by: DACA Ethiopia FDB Ghana. NAFDAC Nigeria PM&PB-Malawi Congo WHO- GMP Manufacturing License MFG. LIC NO. KD 69 in form No. 25 (Other than C & C1). MFG. LIC No. KD 66 in form No. 28 (Under Scheduled C & C1) 11

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13 PLANT PREMISES The plant is updated as per c-gmp norms continuously. It is a two storied building having total built up area of 20,000 sq. ft with areas like Production, Stores, Quality Control, Quality Assurance and Engineering Services and additional area for storage of packing materials. 13

14 SALIENT FEATURES Facility adherence with international norms. Operational rooms equivalent to clean rooms class ISO 5-6 in Aseptic area & class 8 for other Semisolid & Liquid preparation. Dedicated Facility for each formulation section. Air locks to key operational rooms with Door Interlocking System. Controlled environmental conditions. Well equipped QC and Micro Labs. Automated & Semi automated equipment's. Well Established Quality Management System. Established Product Development Facility & Technical Assistance. 14

15 INSTALLED CAPACITY Product Category Qty/ annum in Liters/Kg Quantity/annum in No of bottles/tubes Remarks Liquid orals 2,160,000 21,600, ml bottles External Prepn. Ointment/Gel 270,000 20,700,000 15gm tubes Sterile Ointments 108,000 21,600,000 5gm tubes * Based on 300 working days/year, two shift working at 90% efficiency 15

16 UTILITY SERVICES The utilities like Purified water system, Air Handling System, Oil fired Boiler, Compressed air are well designed and maintained to ensure proper supply of high quality utility services. 16

17 UTILITY SERVICES 17

18 UTILITY SERVICES 18

19 UTILITY SERVICES 19

20 UTILITY SERVICES D G Set 20

21 WATER SYSTEM River SURYA is the source of water supply to whole of M.I.D.C. area. The water is first received by M.I.D.C. & it under goes FILTRATION & PURIFICATION at M.I.D.C. WATER PURIFICATION PLANT. The Potable water is supplied by M.I.D.C & this water treated by in house water treatment plant to produce Purified water. 21

22 PURIFIED WATER SYSTEM 22

23 FOLLOWING IS THE CLOSED LOOP SEQUENCE FOR PURIFICATION OF THE POTABLE WATER TO GET PURIFIED WATER Sand filter Removal of suspended particles. U. V. Treatment To reduce microbial load. C. Activated Carbon filter column : Removal of suspended solids, odors, colour. D. Cation exchange column De-cationisation E. Anion exchange column De-anionisation F. Mixed bed column De-ionization left if any in preceding steps. G.5 Micron Filter To Reduce particulate matter above 5 micron. H. U. V. Treatment Final Disinfectation for water quality. I Ltr. Storage Tank J. U.V. treatment- in return line path. 23

24 KEY EQUIPMENTS IN THE LAB Sr. No. Name Total Nos. Make 1HPLC-ISOCRETIC 1 JASCO 2HPLC-GRADIENT 1 JASCO 3GAS CHROMATOGRAPHY 1 JASCO 4FTIR 1 JASCO 5VISCOMETER 1 Brookfield 6KBR Press 1 TSI Techno Serach Inst. 7UV Spectrophotometer 1 Shimadzu 8Weighing Balance Electronic 2 AND 9Stability Chamber 2 Thermolab 10U V Soectriogitineter 1 Systronic 11Karl Fischer Titrator 1 Veego 12Muffle furnace 1 Pathak Instruments 13Laminar Air Station 1 Microfilt 14BOD 1 Newtronic 15Vacuum Oven 1 Pathak Instruments 16Laboratory Oven 2 Pathak Instruments 17Autoclave 2 Equitron 18Brusting Strength Tester 1 Ubique Enterprises 19Centrifuge 1 Remi 20Colony Counter 1 Pathak Instruments 24

25 KEY EQUIPMENTS IN THE LAB Sr. No. Name Total Nos. Make 21Incubator 3 Pathak Instruments 22Refrigerator 1 Godrej 23Vacuum Dessicator Vernier Caliper 1 Mitutoyo 25Micrometer 1 Mitutoyo 26Distilled Water Plant Sonicator 1 Wadegati Labequip 28Polarimeter 1 Rajdhani 29Digital ph Meter 1 DBK Instruments 30U V Cabinet 1 Expo Hytech 31Melting Point Apparatus 1 DBK Instruments 32Paotofluorimeter 1 Systronics 33Refractometer 1 Advance Research Institute 34Water bath Hot Plate with Stirrer 1 Remi 36Vortex Mixter 1 Elteck 25 37Penetrometer 1 Maharana

26 QUALITY CONTROL EQUIPMENTS STABILITY CHAMBER 30 C/75% RH 26

27 LAMINAR AIR FLOW BENCH LAMINAR AIR FLOW BENCH- STERILITY SECTION. 27

28 EXTERNAL PREPARATION EQUIPMENTS CREAM/ OINTMENT MANUFACT URING PLANT. 28

29 STERILE OINTMENT EQUIPMENTS AXO-900 FILLING M/C-ITALY 29

30 CARTONATOR MACHINE A-T PACK CARTON PACKING MACHINE 30

31 LIQUID ORAL PLANT LIQUID ORAL MANUFACT URING TANK 31

32 BOTTLE FILLING MACHINE-1 KONARK- KARCS

33 BOTTLE FILLING MACHINE-2 PHARMALAB 33

34 HVAC SYSTEM The plant has total 16 Air Handling Units. Different AHUs are provided for different sections. The Ventilation system is designed to avoid cross contamination. Multiple filters have been provided in the AHUs, thus providing clean good air quality. The pressure differential monitoring system is in operation. The ducts are made of G.I. and insulated to maintain temperature and avoid leakages. In each area the supply air and return diffusers are located apart from each other to give proper distribution of air and avoid short circuit and turbulence 34

35 QUALITY MANAGEMENT SYSTEM Our quality is maintained & supported by Total Involvement of all the Staff & Workers along with the executive management. It is achieved by utilizing various tools like systematic sampling, testing, validation exercises, periodic auditing of materials/facility/system/procedures. The Quality Systems include the control over the Starting materials, In process materials, Packaging materials, Processing and Finished products and monitoring the Quality throughout the shelf life of the product through adequate long term/accelerated stability studies. Quality risk management ( QRM). These control systems are supported by adequate Documentation System including Master Formulae, Batch Processing Instructions, Raw Materials/In process/ Packaging Materials and Finished Product Specifications. 35

36 QUALITY MANAGEMENT SYSTEM SOPs Document Management. Change control Management. Deviation Management. Handling of Market complaints. Corrective Action Preventive Action. Self Inspections. Quality risk management. Line clearance & In process checks. Training. 36

37 ORGANOGRAM 37

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43 Factory Layout Ground Floor First Floor Second Floor 43

44 LAYOUT PLAN MAN MATERIAL MOVEMENT GROUND FLOOR Ground floor : Liquid manufacturing, filling and packing, BSR, Bottle washing, Raw Material Stores, Sugar Storage. 44

45 LAYOUT PLAN MAN MATERIAL MOVEMENT FIRST FLOOR 1 st floor: Quality Control Laboratory, Ointment Mfg. (Non sterile) filling, packing, Ointment Mfg. (Sterile), filling, packing, Overprinting room. 45

46 LAYOUT PLAN MAN MATERIAL MOVEMENT SECOND FLOOR 2 nd floor : Control sample room, Change rooms, Quality assurance room, Packing material 46 stores.

47 AREA CLASSIFICATION GROUND FLOOR 47

48 AREA CLASSIFICATION FIRST FLOOR 48

49 AREA CLASSIFICATION SECOND FLOOR 49

50 Our vision is to be a leading pharmaceutical company in India and to become a significant global player by providing high quality, affordable and innovative solutions in medicine A business that makes nothing but money is a poor business. Henry Ford

QUALITY CONTROL DEPARTMENT EQUIPMENT LIST

QUALITY CONTROL DEPARTMENT EQUIPMENT LIST 1. Precisa Analytical balance XB220A Precisa FTIR room PRL/QC/001 (XB220A) 2. Centrifuge machine -- Multitech Instrumentation Room PRL/QC/002 3. Disintegration test machine 1 -- Multitech Instrumentation