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IPQC SOLID DOSAGE FORMS

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IN PROCESS QUALITY CONTROL SOLID DOSAGE FORMS BY PANDYA YOGI

IN PROCESS QUALITY CONTROL SOLID DOSAGE FORMS BY PANDYA YOGI

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  • 1. IN PROCESS QUALITY CONTROL TESTS FOR SOLID DOSAGE FORMS
    • Guided By: Hiren Kadikar
    • Presented By: Yogi Pandya
    ARIHANT SCHOOL OF PHARMACY & BIORESEARCH INSTITUTE Department of Quality Assurance M.Pharm. Sem: I
  • 2. What Do You Mean By “IPQC” …?
    • IPQC is concerned with providing accurate , specific , & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms.
    “ INSPECTION” “ TESTING”
  • 3. SOLID DOSAGE FORMS
    • Tablets
    • Capsules
    • Powders
      • Effervescent
      • Oral
      • Insufflations
      • Dentifrice
      • Dusting
    • 4. Lozenges
  • 4. TABLETS Que: Is it easy to manufacture a “tablet” ? Ans: No…
  • 5. Steps Of Tablet Manufacturing
    • Weighing
    • Screening
    • Milling
    • Mixing
    • Granulation
    • Blending
    • Compression
    • Packaging
    • Labeling
  • 6. Quality Checks During Manufacturing
  • 7. IPQC Parameters to be measured I. Physical Parameters : a. temp b. time c. particle size & texture d. pressure mmH 2 O e. weight f. hardness g. thickness & diameter h. disintegration i. dissolution ( % release) j. friability k. moisture content %relative humidity
  • 8.  
  • 9. BMR for Tab Mfg Process Date Time Operation Room No. Temp °C %RH Diff. press (mm H2O) signature Dispensing 23 42 2.0 Sifting 48 1.8 Milling 2.0 Blending Compression Coating
  • 10. Compression Parameters Parameter Limit Observation Machine speed 20 rpm (15-25 rpm) Wt. of 20 tabs 12.00g + 2 (11.76-12.24g) Theoretical weight/tab 600mg Hardness 25Kg (20-30 Kg) Thickness (av. of 10 tabs) 4.10mm + 0.15mm (3.95 – 4.25mm) Length 10mm + 0.1 mm (9.9 – 10.1 mm) Width 5 mm + 0.1mm (4.9 – 5.1 mm) Disintegration time NMT 15 mins Wt. variation + 3% of Av. Wt. Friability (10 tabs) NMT 1.0% w/w
  • 11. IPQC checks frequency during mfg. Parameter Frequency Wt. of 20 tabs Every hour by production and every two hours by QA Hardness, thickness, length, width Every hour by production , every two hours by QA Wt. variation Every half hour by production and every hour by QA DT Every half hour by production , every hour by QA
  • 12. CAPSULES
  • 13. Steps Of Capsule Manufacturing
    • Mfg of Gelatin Shell.
    • Drying of shells in controlled humidity.
    • Mfg of granules/spanzules.
    • Filling of Shells.
    • Packaging & Labeling.
  • 14. IPQC Checks During Gelatin Shell Manufacturing
    • % purity of gelatin
    • Viscosity of gelatin solution 25-45 millipoise
    • Bloom strength of gelatin solution 150-250 gm
    • Iron content NMT 15 ppm
    • pH of gelatin A=9; B=4.7
    • Film Thickness
    • Color, surface, appearance of empty shells
    • Temperature of hot air, for drying of shells
    • Length of Capsule & Body of the shell
    • Moisture content 12-15%
  • 15.
    • Sorting of defective shells
    • After the capsules have been inspected either
    • electronically or manually, they are sampled by the
    • QA inspector & checked for the defects and then
    • sorted out.
    • Printing inspection on shell
    • Inspection of defects like:-
        • Hardening of shells
        • Softening of shells
        • Swelling of shells
        • Cracking of shells
        • Discoloration of shells
        • Misprinting of logo on shells
  • 16. IPQC Checks During Filling Of Empty Capsule Shells
    • During filling process equipment should be labeled
    • with :-product name, Batch No, Time of starting, Sign
    • During Filling: flow property of granules or powders
    • Weight Variation :
    • For hard gel caps -
      • Limit NMT 2 caps should deviate from avg wt.
      • AVG WT %DEVIATION
      • <300mg 10%
      • >300mg or more 7.5%
  • 17.
    • For soft gel caps:
      • Wg 10 caps
      • Remove inner content by cutting with scissor/blade
      • Wash with solvent & evaporate solvent at room
      • temperature for 30 min
      • Wg the empty shells & calculate % deviation
    • MACHINE OUTPUT INSPECTION:
    • Machine output is monitored in a specific time interval
    • Total batch or number of caps filled are counted in a
    • specific time interval & then machine is calibrated and
    • speed is maintained.
  • 18.
    • APPEARANCE:
    • Inspection of capsules checked with a standard strip
    • SORTING DEFECTS:
    • Electronic automated or manual inspection is made to sort out & reject the defected caps.
    • Overprinting
    • PRINTING & LABELING:
        • Inspection of overprinting, logo, labeling are checked with the standard shade cards.
        • Defective ones are sorted out & rejected.
  • 19. LOZENGES Que- Are they different from Tablets? Ans- Yes..
  • 20. Steps For Manufacturing Of Lozenges
      • Weighing
      • Mixing
      • Sifting
      • Granulation
      • Moulding/Compression at low pressure
      • Packaging & Labeling
  • 21. IPQC Checks During Manufacturing
    • Visual inspection
    • Shape, size, color
    • Weight variation
    • Overprinting logo
    • Uniformity
    • Disintegration
    • Packaging & Labeling
  • 22. POWDERS
  • 23. Types Of Powders
    • Effervescent powders
    • Dusting powders
    • Insufflations (Inhalers)
    • Dentifrice
    • Oral powders
  • 24. Flow Chart Of Powder Manufacturing
  • 25. IPQC Checks During Powder Manufacturing
    • Particle size & shape
    • Texture
    • Powder flow
    • Fluffiness
    • Density
    • Foreign Impurities
    • Moisture
    • Packaging
    • - sealing, printing
  • 26.
    • 1. Effervescent Powders:
    • sample powder in 250ml of water produces
    • effervescence & dissolves in 12sec.
    • Dusting Powder:
    • color, texture, density, particle size, flow, fluffiness, spread ability
    • Insufflations:
    • flow, particle size, density
    • Dentifrice:
    • abrasion, texture, particle size, color
  • 27. Powder Flow & Texture Analyzer
  • 28.
    • Powder Flow Analyzer used to measure:
      • Flow
      • Texture
      • Caking
      • Cohesion
      • Flow Speed
      • Granule attrition
      • Compaction & Relaxation
      • Dusting
      • Surface Friction
      • Aggregation
      • Air-entrapment
      • Granulation
  • 29. Parameters Measured:
    • (principle-slicing, shearing, compaction)
    • speed of rotor blade
    • blade angle
    • path of blade
    • resistance in speed and angle
    • axial force
    • time distance travelled
    • Measured by a sensitive transducer attached to rotor blades.
  • 30. REFERENCES:
    • WHO Guidelines For Good Manufacturing
    • Practices
    • 2. Guidance For Industry: Nonsterile Dosage Forms; US Dept. of health & human services
    • 3. Manohar A Potdar; current-Good Manufacturing Practices , Edn-2003.
    • D.H.Shah; standard operating procedures.
    • Satish Maliya; WHO Guidelines; Issue-Jan-19-22;2011.
    • WHO public inspection report of finished product manufacturing
  • 31.