1. WELCOME TO W I S E PHARMACEUTICALS

2. TOTAL AREA Total area of plot = 21504.00 Sq. Ft. Covered Area of
Ground Floor Building = Sq. Ft.
Basement = Sq. Ft.
Total Covered Area = Sq. Ft.

3. TECHNICAL STAFF RANA ALI RAZA PRODUCTION MANAGER.
UZMA YOUNUS QUALITY CONTROL MANAGER.
FAROOQ AHMED PRODUCTION PHARMACIST.
MUHAMMAD AKRAM PRODUCTION PHARMACIST.
GHAZANFAR MAHMOOD PRODUCTION PHARMACIST.
MUHAMMAD NOMAN ASLAM PRODUCTION PHARMACIST.
KIFFAYAT ULLAH PRODUCTION PHARMACIST.
M. AZAM PRODUCTION PHARMACIST.
KAMRAN SIDDIQUE Q.C ANALYST
ASIM KHAN MICROBIOLOGIST.
TANVEER AHMAD Q.A. OFFICER.

4. TOTAL SECTIONS IN APPROVED LAY OUT PLAN;
QUINOLONE TABLET SECTION
GENERAL TABLET SECTION
GENERAL CAPSULE SECTION
CEPHALOSPORIN CAPSULE SECTION
CEPHALOSPORIN DRY SUSPENSION SECTION
INJECTABLE CEPHALOSPORIN SECTION

5. SECTION APPLIED FOR APPROVAL;
QUINOLONE TABLET SECTION
GENERAL TABLET SECTION
GENERAL CAPSULE SECTION
CEPHALOSPORIN CAPSULE SECTION
CEPHALOSPORIN DRY SUSPENSION SECTION
INJECTABLE CEPHALOSPORIN SECTION

6. MACHINARY IN GENERAL/QUINOLONE TABLET SECTION;
HORIZONTAL MIXER
CONE MIXER
OSCILLATING GRANULATOR
ROTARY ZP-17
TRAY DRYER
BLISTER MACHINE DPP-250 & DPP-140
COATING PAN
PRESSURE VESSLE TANK WITH COATING ASSEMBLY
SILVERSON MIXER

7. HORIZONTAL MIXER;

8. CONE MIXER;

9. OSCILLATING GRANULATOR;

10. ROTARY ZP-17;

11. TRAY DRYER;

12. BLISTER MACHINE; DPP-250

13. COATING PAN;

14. PRESSURE VESSLE TANK WITH COATING ASSEMBLY& SILVERSON

15. DRYING OVEN;

16. GENERAL/CEPHALOSPORINS CAPSULE SECTION;
CONE MIXER
CAPSULE FILLING MACHINE
CAPSULE POLISHING MACHINE

17. CONE MIXER;

18. CAPSULE FILLING MACHINE;

19. CAPSULE POLISHING MACHINE;

20. CEPHALOSPORINS INJECTABLE SECTION;
VIALS WASHING MACHINE
DOUBLE DOOR DRY HEAT STERILIZER
DOUBLE DOOR AUTOCLAVE
VIALS FILLING MACHINE
VIALS SEALING MACHINE

21. VIALS WASHING MACHINE;

22. DOUBLE DOOR DRY HEAT STERILIZER;

23. DOUBLE DOOR AUTOCLAVE;

24. VIALS FILLING MACHINE;

25. VIALS SEALING MACHINE;

26. LIST OF Q.C EQUIPMENTS; H.P.L.C. PRECISION BALANCE ( SHIMADZU)
DIGITAL HARDNESS TESTER
TOP-LOADING BALANCE
pH METER
HOT AIR OVEN
WATER BATH
DISINTEGRATION TEST APPARATUS
DISSOLUTION TEST APPARATUS
FRIABILTY TEST APPARATUS
KARL FISCHER TITRATOR
MAGNETIC STIRRER WITH HOT PLATE
POLARIMETER
MELTING POINT APPARATUS (DIGITAL)

27. CONTINUED; CENTRIFUGE MACHINE AUTOCLAVE INCUBATOR MICROSCOPE
LAMINAR FLOW CABINET
REFRIGERATOR
COLONY COUNTER
UV / VIS SPECTROPHOTOMETER
HEATING MANTLE
MUFFLE FURNACE
STERILITY TEST ASSEMBLY
GLASS DISTILLATION ASSEMBLY
L.A.L TEST ASSEMBLY
CONDUCTIVITY METER
DESICCATOR

28. H.P.L.C.

29. PRECISION BALANCE (SHIMADZU)

30. DIGITAL HARDNESS TESTER

31. TOP-LOADING BALANCE

32. pH METER

33. HOT AIR OVEN

34. WATER BATH

35. DISINTEGRATION TEST APPARATUS

36. DISSOLUTION TEST APPARATUS

37. FRIABILITY TEST APPARATUS

38. KARL FISCHER TITRATOR

39. MAGNETIC STIRRER WITH HOT PLATE

40. POLARIMETER

41. MELTING POINT APPARATUS

42. CENTRIFUGE MACHINE

43. AUTOCLAVE

44. INCUBATOR

45. MICROSCOPE

46. LAMINAR FLOW CABINET

47. REFRIGERATOR

48. COLONY COUNTER

49. UV / VIS SPECTROPHOTOMETER

50. HEATING MANTLE

51. MUFFLE FURNACE

52. STERILITY TEST ASSEMBLY

53. GLASS DISTILLATION ASSEMBLY

54. CONDUCTIVITY METER

55. DESICCATOR

56. DOCUMENTS; SOPs CONTROL DOCUMENTS GENERAL SOPs Operational Cleaning
Process
Q.C SOPs
CONTROL DOCUMENTS
GENERAL SOPs

57. CLEANING AND SANITATION;
SPECIMEN
CLEANING
SWEEPING
MOPPING
WASHING
DRYING
PAINTING
FUMIGATION
FLOORS
----
Daily
Monthly
SIX Monthly
CORRIDORS
-----
Twice Daily
DOORS
Weekly
When Required
DUCTS-EXHAUST FAN
FANS/LIGHTS
Quarterly
WASTE BIN
WALLS
------
WINDOWS
GLASSES
SHELVES
CEILINGS
MAIN GATE
WATER TANK
Six Monthly
---
TOILETS
Four Time a Day
Hourly
BASINS

58. MAINTENANCE SCHEDULE OF MACHINES;
DEDUSTING
/MOWING
GENERAL CLEANING
OILING/COMPLETE
CHANGE OF PARTS
ROTARY ZP-17
Daily
After every Batch
After Six Months
When Required
BLISTER MACHINE
INJECTABLE FILLING MACHINE (DRY POWDER)
INJECTABLE SEALING MACHINE (DRY POWDER)
CAPSULE MACHINE
Dry POWDER FILLING MACHINE
BOTTLE BLOWER
BOTTLE DRIER
TRAY DRIER
CONE MIXER
HORIZONTAL MIXER
GRANULATOR

59. Tableting Process Flow Chart
Approved Raw Material
Line Clearance 1
Dispensing
Line Clearance 2
=Process
Sieving DI
RECT
MIXING W E T G R A N U L I O
Sieving
=Q.A.
=Q.C.
Mixing
Mixing
1. Weight, Lot No. checking, Potency Adjustment.
2.Countercheck of
weights,Cleanliness, SMP.
3. QC Release, Cleanliness, Documents.
4. QC Release, Cleanliness, Compressed tablets, Prepared Soln.
5. B.No. Expiry date embossing on blister, cavities, tablets, cleanliness, documents.
6. B.No. Expiry date embossing on blister and Packing Material, Cleanliness, documents.
7. Assay of granules, M.C.
8. D.T., Friability, Dissolution, Average Weight, Hardness, Assay.
9. D.T., Dissolution, Average Weight, Hardness, Assay.
10. Packaging, Batch No., Mfg. Date, Expiry Date, Assay.
Wetting
Lubrication
Wet Granulation
QC Check 8
Line Clearance 3
Drying
Compression
Lubrication
Granulation
Line Clearance 4
QC Check 7
Line Clearance 6
Line Clearance 5
Blistering/ Stripping/ Jar filling
Coating
Packing
QC Check 9
QC Check 10
Transfer to Finished Goods Store
Transfer to Finished Goods Quarantine

60. Dry Suspension Process Flow Chart;
Dispensing
Sieving
Blending
Filling
Sealing
Labeling
Packing
Transfer to Finished Goods Quarantine
Transfer to Finished Goods Store
Approved Raw Material
Line Clearance 2
Line Clearance 3
Line Clearance 4
Line Clearance 5
QC Check 7 6 8
=Process
=Q.A.
=Q.C.
1. Weight, Lot No. checking, Potency Adjustment
2. Countercheck of weights, Cleanliness, SMP., Temp., Humidity.
3. B. No., Capsule shell size and filled weight, Cleanliness, Documents.
4. B.No. Expiry date embossing on blister, cavities, tablets, cleanliness, documents
5. B.No. Expiry date embossing on blister and Packing Material, Cleanliness, documents.
6. Assay of mixed powder, M.C.
7. Dissolution/ D.T., Filled weight, Assay.
8. Packaging, Batch No., Mfg. Date, Expiry Date, Assay
Line Clearance 1

61. Encapsulation Process Flow Chart
Dispensing
Sieving
Blending
Lubrication
Capsule Filling
Blistering
Packing
Transfer to Finished Goods Quarantine
Transfer to Finished Goods Store
Approved Raw Material
Line Clearance 2
Line Clearance 3
Line Clearance 4
Line Clearance 5 7
QC Check 6 8
=Process
=Q.A.
=Q.C.
1. Weight, Lot No. checking, Potency Adjustment
2. Countercheck of weights, Cleanliness, SMP., Temp., Humidity.
3. B. No., Capsule shell size and filled weight, Cleanliness, Documents.
4. B.No. Expiry date embossing on blister, cavities, tablets, cleanliness, documents
5. B.No. Expiry date embossing on blister and Packing Material, Cleanliness, documents.
6. Assay of mixed powder, M.C.
7. Dissolution/D.T,Filled weight, Assay.
8. Packaging, Batch No., Mfg. Date, Expiry Date, Assay
Line Clearance 1

62. INJECTABLES PROCESS FLOW CHART;
DE-CARTONING OF VIALS
WASHING
Q.C CHECK
FLIP OFF SEALS/ RUBBER STOPPER
VIALS
STERLIZATION
Q.C CHECK
FILLING OF VIALS
Q.C CHECK
DRY STERILIZATION OF VIALS
DRY + WET STERILIZATION OF FLIP OFF SEAL & RUBBER STOPPER
SEALING OF FILLED VIALS
Q.C CHECK
OPTICAL CHECKING
Q.C CHECK
LABELING & PACKING
Q.C CHECK
TRANFER TO FINISHED GOODS STORE
Q.C CHECK

63. (STANDARD OPERATING PROCEDURES)
S O P s
(STANDARD OPERATING PROCEDURES)

64. CLEANING SOPs CLEANING OF BLISTER MACHINE CLEANING OF CONE MIXER
CLEANING OF DRIER
CLEANING OF COATING PAN
CLEANING OF GRANULATORS
CLEANING OF ROTARY
CLEANING OF RIBBON MIXER
CLEANING OF CAPSULE FILLING MACHINE
CLEANING CAPSULE POLISHER
CLEANING OF BOTTLE BLOWER
CLEANING OF POWDER FILLING MACHINE
CLEANING OF DRY POWDER INJECTABLE FILLING & SEALING MACHINE
CLEANING OF DOUBLE DOOR STERILIZER & AUTOCLAVE

65. OPERATIONAL SOPs OPERATION OF BLISTER MACHINE.
OPERATION OF CONE MIXER.
OPERATION OF DRYER.
OPERATION OF COATING PAN.
OPERATION OF GRANULATORS.
OPERATION OF ROTARY.
OPERATION OF RIBBON MIXER.
OPERATION OF CAPSULE FILLING MACHINE.
OPERATION CAPSULE POLISHER.
OPERATION OF BOTTLE BLOWER.
OPERATION OF POWDER FILLING MACHINE.
OPERATION 0F SILVER SON MIXER.
OPERATION FOR CAPPING MACHINE.
OPERTION OF DOUBLE DOOR STERILIZER & AUTOCLAVE.
OPERATION OF DRY POWDER INJECTABLE FILLING & SEALING MACHINE.

66. GENERAL SOPs ENTRY IN TO THE PRODUCTION AREA OF THE UNIT
SAMPLING IN PRODUCTION AREA
USE OF TO BE CLEANED TAG
USE OF READY FOR USE TAG
USE OF OUT OF ORDER TAG
Q.C CHECKS/ANALYSIS
USE OF IDENTIFICATION SLIPS
USE OF FIRE EXTINGUISHERS

67. PROCESS SOPs PROCESS OF GRANULATION PROCESS OF DRYING
PROCESS OF MIXING
PROCESS OF COMPRESSION
PROCESS OF COATING
PROCESS OF BLISTERING
PROCESS OF PACKING
PROCESS OF SORTING
PROCESS OF LABELING OF FILLED BOTTLES
PROCESS OF RAW MATERIAL SAMPLING
PROCESS OF PACKAGING SAMPLING
PROCESS OF DISPENSING
USE OF RAW MATERIAL APPROVED LABEL
USE OF SAMPLED LABEL
USE OF NOT APPROVED LABEL

68. Q.C SOPs GENERAL SOPs GOOD LABORATORY PRACTICES
WORKING REFERENCE STANDARDS
PRODUCT RECALL SYSTEM
STABILITY TEST PROGRAM
CONTROL REFERENCE SAMPLE
Q.C CHECK/ANALYSIS(SOLUBILITY)
STANDARDIZATION OF VOLUMETREC SOL.
SUPERVISION OF ANALYSIS
VOLUMETRIC SOLUTION &REAGENTS
FOR Q.C CHECK/ANALYSIS(IDENTIFIEATION)
FOR Q.C CHECK/ANALYSIS
FOR Q.C CHECK/ANALYSIS(CONCENTRATION)
FOR Q.C CHECK/ANALYSIS(CHARACTERS)

69. FOR Q.C CHECK/ANALYSIS(FRESHLY &RECENTLY PREPARED)
FOR Q.C CHECK / ANALYSIS (WATER)
BLISTER SEALING TEST
ANALYSIS OF TABLET
STORGE CONDITION
REJECTED IN PROCESS GOOD &PACKING MATERIAL
RE TESTING OF RAW MATERIAL
SELF INSPECTION
ANALYSIS OF CAPSULE
CLEANING OF LAB. FLOOR GENERAL PROCEDURE FOR CLEANING GLASSWARE
PROCEDURE FOR SAMPLE AND RELEASE OF RAW MATERIAL
PROCEDURE FOR PRODUCT SAMPLING /APPROVAL
PROCEDURE FOR RELEASE OF FINISHED PRODUCT

70. EVALUTION OF SUPPLIERS
LAMINAR FLOW
ENTRY INTO MICROBIOLOGY LAB
PROCEDURE FOR SAMPLE AND RELEASE OF RAW MATERIAL
PROCEDURE FOR PRODUCT SAMPLING /APPROVAL
PROCEDURE FOR RELEASE OF FINISHED PRODUCT
ENVIRONMENT CONTROL
COLONY COUNTER

71. Q.C SOPs Instrument's SOP’s CENTRIFUGE MACHINE.
VERNIER CALIPER(DIGITAL).
ANALYTICAL BALANCE.
WATER BATH.
DISSOLUTION TEST.
COOL INCUBATOR.
VACUUM DESICATOR.
DISINTEGRATION TESTING APPARATUS.
CALIBRATION OF DISINTAGRATION TEST APPARATUS.
pH METER CALIBRATION.
TOP LOAD BALANCE
THERMOMETER.
STOP WATCH.
SPECTROPHOTOMETER.
H.P.L.C .

72. CALIBRATION OF REFRACTOMETER.
CALIBRATION OF OVEN.
KARL FISHER.
HARDNESS TESTER .
MEMMERT OVEN.
POLARIMETER
MELTING POINT TESTER MPID.
LAB TECH INCUBATOR.
FRIABILATOR(GALVANO).
TOP LOAD BALANCE DIGITAL.
IR SPECTROPHOTOMETER.
LAMINAR FLOW.
ENVIRONMENT CONTROL.
COLONY COUNTER.

73. LIST OF DOCUMENTS PLANNING REPORT. MANUFACTURING ORDER.
PACKAGING ORDER.
YIELD MONITORING REPORT.
BATCH CONTROL RECORD.
QUALITY CONTROL REPORT (GRANULES).
WEIGHT CONTROL SHEET.
QUALITY CONTROL REPORT (CORES).
COATING CONTROL SHEET.
QUALITY CONTROL REPORT (COATED TAB).
BLISTER CONTROL SHEET.
PRINTING CONTROL SHEET.

74. PACKAGING CONTROL SHEET.
GATE PASS.
GRN.
MATERIAL REQUISITION SHEET.
Q.C PASS CERTIFICATE.
MATERIAL DESTRUCTION SHEET.
PERSON.
LEAVE APPLICATION FORM.
REPORT FOR AMENDMENT.
IMPROVEMENT ACTION REPORT.
CHECK LIST.
AUDIT REPORT.
APPROVED SUPPLIER LIST.
DEMAND ORDER.
PURCHASE ORDER.

75. PROVISION OF HVAC SYSTEM
OBJECTIVES

76. TO CONTROL CROSS CONTAMINATION.
TO ACHIEVE PROPER AIR HANDLING/AIR CHANGES.
TO AVOID EXTERNAL ENVIRONMENTAL INVOLVATION.

77. SECTIONS HAVING ‘HVAC’ FACILITY
QUINOLONE TABLET SECTION
GENERAL TABLET SECTION
GENERAL CAPSULES SECTION
RAW MATERIAL STORE
FINISHED GOODS STORE

78. SECTIONS HAVING ‘HVAC’ FACILITY (Segregated Sections)
CEPHALOSPORINS Dry Suspensions
CEPHALOSPORINS Capsule Section
Injectable CEPHALOSPORINS Section

79. LIST OF PRODUCTS

80. 1 Sofenac SR Tablet 2 Arofen 100mg Tablet 3 Fexofen 120mg Tablet 4
Each tablet contains:-
Diclofenac Sodium ………..100mg
(Anti Rheumatic) 2
Arofen 100mg Tablet
Each tablet contains Flurbiprofen equivalent to mg
(Anti-rheumatics, Cycloplegics ) 3
Fexofen 120mg Tablet
Each Tablet Contains Fexofenadin equivalent to mg
(Antihistamines, Systemic ) 4
Relaxit 2mg Tablet
Each tablet contains Tizanidine HCl equivalent to mg
(Muscle Relaxants ) 5
Lerozin 10mg Tablet
Each tablet contains Levocitrazine 2HCl equivalent to mg

81. 6 Hazim Tablet 7 Zest Tablet 8 Depot Tablet 9 Ranitone Tablet 10
Each Tablet Contains Famotidine Equivalent to--- 40mg
(Antipeptic Ulcerants ) 7
Zest Tablet
Each Tablet contains Citalopram mg 8
Depot Tablet
Each Tablet contains Diclofenac K mg 9
Ranitone Tablet
Each Tablet contains Ranitidine HCl mg 10
Nisid Tablet
Each Tablet contains Naproxen Na mg

82. 11 Nime Tablet 12 Biozol 20 Capsule 13 Biozol 40 Capsule 14
Each Tablet contains Nimesulide mg 12
Biozol 20 Capsule
Each capsule contains Omeprazole pellets mg 13
Biozol 40 Capsule
Each capsule contains Omeprazole pellets mg 14
Arson 30 Capsules
Each Capsule contains Lansoprazole pellets mg 15
Esowis 20 Capsule
Each capsule contains Esomeprazole pellets mg

83. 16 Esowis 40 Capsule 17 Pain Kil Capsule 18 Wisamine Capsule 19
Each capsule contains Esomeprazole pellets mg 17
Pain Kil Capsule
Each Capsule contains Piroxicam mg 18
Wisamine Capsule
Each Capsule Contains Mecobalamine µg 19
Minowis Capsule
Each Capsule contains Minocycline HCl mg 20
Bacus 250 Tablet
Each Tablet contains Ciprofloxacin HCl mg

84. 21 Bacus 500 Tablet 22 Klarin 250 Tablet 23 Levotrax 250 Tablet 24
Each Tablet contains Ciprofloxacin HCl mg 22
Klarin 250 Tablet
Each Tablet contains Clarithromycin mg 23
Levotrax 250 Tablet
Each tablet contains Levofloxacin Hemihydrate mg 24
Levotrax 500 Tablet
Each tablet contains Levofloxacin Hemihydrate mg 25
Floxicare Tablet
Each Tablet contains Ofloxacin mg

85. 26 Roxipro Tablet 27 Wislor 250 Capsule 28 Wislor 500 Capsule 29
Each Tablet contains Roxithromycin mg 27
Wislor 250 Capsule
Each Capsule contains Cefaclor mg 28
Wislor 500 Capsule
Each Capsule contains Cefaclor mg 29
Megacef 400 Capsule
Each Capsule contains Cefixime mg 30
Wicef 250 Capsule
Each Capsule contains Cephradine mg

86. 30 Wicef 500 Capsule 31 Wicef 125 Suspension 32 Wicef 250 Suspension
Each Capsule contains Cephradine mg 31
Wicef 125 Suspension
Each Bottle contains Cephradine mg 32
Wicef 250 Suspension
Each Bottle contains Cephradine mg

87. 33 Megacef Suspension 34 Wislor 125 Suspension 35
Each Bottle contains Cefixime mg 34
Wislor 125 Suspension
Each Bottle Contains Cefaclor mg 35
Wislor 250 Suspension
Each Bottle Contains Cefaclor mg

88. 36 Wixone 250 Injection 37 Wixone 1000 Injection 38
Each Vial Contains ceftriaxone Na mg 37
Wixone 1000 Injection
Each Vial Contains ceftriaxone Na mg 38
Bactocid 250 Injection
Each Vial Contains Cefotaxime Na mg

89. 39 Bactocid 1000 Injection 40 Tripim 1000 injection 41
Each Vial Contains Cefotaxime Na mg 40
Tripim 1000 injection
Each Vial Contains Cefepime mg 41
Cefpeck 250 Injection
Each Vial Contains cefuroxime mg

90. 42 Cefpeck 750 Injection 43 Wicef 250 Injection 44 Wicef 500 Injection
Each Vial Contains cefuroxime mg 43
Wicef 250 Injection
Each Vial Contains Cepharadine mg 44
Wicef 500 Injection
Each Vial Contains Cepharadine mg

91. 45 Panacef 1000 Injection 46 Tazobid 250 Injection 47
Each Vial Contains Cefoperazone Na mg 46
Tazobid 250 Injection
Each vial Contains Ceftazidine mg 47
Tazobid 1000 Injection
Each vial Contains Ceftazidine mg