ACHIEVING WORLD STANDARDS THROUGH QUALITY IN PROCESS. Presented by, Nimish Shroff (Director) M/s. Charak Pharma Pvt. Ltd.

Transcription

1 ACHIEVING WORLD STANDARDS THROUGH QUALITY IN PROCESS Presented by, Nimish Shroff (Director) M/s. Charak Pharma Pvt. Ltd.

2 CONTENTS INTRODUCTION REQUIREMENTS AS PER GMP QUALITY MANAGEMENT SYSTEMS PERSONNEL PREMISES AND EQUIPMENT DOCUMENTATION MANUFACTURING QUALITY CONTROL & ASSURANCE INSPECTION PREMISES AND EQUIPMENT REQUIREMENTS CHANGE ROOMS PRIMARY / SECONDARY WAREHOUSE AREA MANUFACTURING AREA QUALITY ASSURANCE & CONTROL AREA

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7 REQUIREMENTS AS PER GMP

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13 PREMISES AND EQUIPMENT REQUIREMENTS

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15 DESIGN

16 DEDICATED AREAS

17 LAYOUT SAMPLE OF FACTORY LAYOUT REJECT AREA LABELING/ PACKAGING QUARANTINE AREA RECEIVING APPROVED PM FINISHED PRODUCTS STORAGE AREA SAMPLING RM LABEL STORAGE / CODING AREA AIR LOCK LABELING/ PACKAGING FILLING BULK STORAGE COMPOUNDING BULK STORAGE LABELING/ PACKAGING FILLING BULK STORAGE COMPOUNDING LABELING/ PACKAGING FILLING CLEAN EQUIPMENT STORAGE LOCKERS COMPOUNDING/ FILLING WASHING AREA MICRO QUALITY CONTROL AREA FEMALE APPROVED RM WEIGHING LOCKERS MALE Material flow through plastic door personnel packaging materials raw/bulk materials Finished products

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19 CHANGE ROOM IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

20 CHANGE ROOM AS PER GMP

21 CHANGE ENTRY / EXIT FOR PRIMARY CHANGE ROOM AS PER GMP

22 ENTRY / EXIT FOR SECONDARY CHANGE ROOM AS PER GMP

23 WAREHOUSE AS PER GMP NORMS

24 WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT RECEIVING OF RAW MATERIAL

25 LOADING & UNLOADING AS PER GMP

26 WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT HERB S STORE

27 WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT SUGAR STORE

28 WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT UNDER TEST AREA REJECTED AREA

29 RECEIPT OF RAW & PACKING MATERIAL AS PER GMP RECEIVING BAY RM & PM

30 SAMPLING AREA AS PER GMP MAN ENTRY SAMPLING AREA MATERIAL ENTRY

31 SAMPLING OF RAW MATERIALS AS PER GMP SAMPLING BOOTH CLEANED SAMPLING DEVICES

32 STORGE OF RAW MATERIALS AS PER GMP

33 A.C. STORAGE AREA AS PER GMP

34 QUARANTINE & REJECTED AREAS AS PER GMP

35 WEIGHING & DISPENSING

36 DISPENSING OF RAW MATERIALS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

37 WEIGHING & DISPENSING AS PER GMP

38 STORAGE OF PRIMARY PACKING MATERIALS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

39 STORAGE OF PRINTED PACKING MATERIAL AS PER GMP

40 A.C. STORAGE OF PRIMARY PACKING MATERIAL AS PER GMP

41 MANUFACTURING & PACKING AREAS

42 CONSTRUCTION AS PER GMP FLOORS

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44 WALLS & CEILINGS AS PER GMP

45 WALLS & CEILINGS AS PER GMP CEILING WITHOUT JOINT FLOOR CEILING WITH JOINT

46 JOINTS & FRAMES AS PER GMP THE JOINTS OF ALL SURFACES THE DESIGNS OF WINDOWS AND THE WAY THEY FIT INTO THE FRAMES

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48 VENTILATION AS PER GMP

49 MANUFACTURING AREA AS PER GMP

50 EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT DISTILLATION ASSEMBLY

51 EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT LIQUID MANUFACTURING TANKS

52 EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT MANUFACTURING TANK TANK WITH STIRRER

53 EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

54 EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP

55 EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP LIQUID MANUFACTURING VESSELS

56 EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP DOUBLE E CONBLENDER MULTIMILL HYDRAULIC LIFTER SIFTER

57 EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP CAPSULE FILLING MACHINE

58 EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP RAPID MIXER GRANULATOR

59 EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP FLUIDISED BED DRYER FBD BOWL TRANSFER TO CONTA BIN

60 EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP BLENDER WITH CONTA BIN

61 EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP

62 EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP NEOCOTA TABLET COATING SYSTEM

63 PACKAGING AREA IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

64 PACKAGING AREA IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

65 PACKAGING AREA AS PER GMP

66 EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP BOTTLE WASHING MACHINE

67 EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP BOTTLE FILLING & SEALING MACHINE

68 EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP VISUAL INSPECTION

69 EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP BLISTER PACKING MACHINE

70 EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP VISUAL INSPECTION AT CONVEYER BELT

71 QUALITY ASSURANCE & CONTROL AREA REFERENCE STANDARD LABORATORY APPARATUS RECORD CUPBOARD REAGENT & SOLVENT

72 CONCLUSION

73 Thank You!