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  1. 1. IN PROCESS QUALITY CONTROL TESTS FOR SOLID DOSAGE FORMS <ul><li>Guided By: Hiren Kadikar </li></ul><ul><li>Presented By: Yogi Pandya </li></ul>ARIHANT SCHOOL OF PHARMACY & BIORESEARCH INSTITUTE Department of Quality Assurance M.Pharm. Sem: I
  2. 2. What Do You Mean By “IPQC” …? <ul><li>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. </li></ul>“ INSPECTION” “ TESTING”
  3. 3. SOLID DOSAGE FORMS <ul><li>Tablets </li></ul><ul><li>Capsules </li></ul><ul><li>Powders </li></ul><ul><ul><li>Effervescent </li></ul></ul><ul><ul><li>Oral </li></ul></ul><ul><ul><li>Insufflations </li></ul></ul><ul><ul><li>Dentifrice </li></ul></ul><ul><ul><li>Dusting </li></ul></ul><ul><li>4. Lozenges </li></ul>
  4. 4. TABLETS Que: Is it easy to manufacture a “tablet” ? Ans: No…
  5. 5. Steps Of Tablet Manufacturing <ul><li>Weighing </li></ul><ul><li>Screening </li></ul><ul><li>Milling </li></ul><ul><li>Mixing </li></ul><ul><li>Granulation </li></ul><ul><li>Blending </li></ul><ul><li>Compression </li></ul><ul><li>Packaging </li></ul><ul><li>Labeling </li></ul>
  6. 6. Quality Checks During Manufacturing
  7. 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
  9. 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
  10. 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
  11. 12. CAPSULES
  12. 13. Steps Of Capsule Manufacturing <ul><li>Mfg of Gelatin Shell. </li></ul><ul><li>Drying of shells in controlled humidity. </li></ul><ul><li>Mfg of granules/spanzules. </li></ul><ul><li>Filling of Shells. </li></ul><ul><li>Packaging & Labeling. </li></ul>
  13. 14. IPQC Checks During Gelatin Shell Manufacturing <ul><li>% purity of gelatin </li></ul><ul><li>Viscosity of gelatin solution 25-45 millipoise </li></ul><ul><li>Bloom strength of gelatin solution 150-250 gm </li></ul><ul><li>Iron content NMT 15 ppm </li></ul><ul><li>pH of gelatin A=9; B=4.7 </li></ul><ul><li>Film Thickness </li></ul><ul><li>Color, surface, appearance of empty shells </li></ul><ul><li>Temperature of hot air, for drying of shells </li></ul><ul><li>Length of Capsule & Body of the shell </li></ul><ul><li>Moisture content 12-15% </li></ul>
  14. 15. <ul><li>Sorting of defective shells </li></ul><ul><li>After the capsules have been inspected either </li></ul><ul><li>electronically or manually, they are sampled by the </li></ul><ul><li>QA inspector & checked for the defects and then </li></ul><ul><li>sorted out. </li></ul><ul><li>Printing inspection on shell </li></ul><ul><li>Inspection of defects like:- </li></ul><ul><ul><ul><li>Hardening of shells </li></ul></ul></ul><ul><ul><ul><li>Softening of shells </li></ul></ul></ul><ul><ul><ul><li>Swelling of shells </li></ul></ul></ul><ul><ul><ul><li>Cracking of shells </li></ul></ul></ul><ul><ul><ul><li>Discoloration of shells </li></ul></ul></ul><ul><ul><ul><li>Misprinting of logo on shells </li></ul></ul></ul>
  15. 16. IPQC Checks During Filling Of Empty Capsule Shells <ul><li>During filling process equipment should be labeled </li></ul><ul><li>with :-product name, Batch No, Time of starting, Sign </li></ul><ul><li>During Filling: flow property of granules or powders </li></ul><ul><li>Weight Variation : </li></ul><ul><li> For hard gel caps - </li></ul><ul><ul><li> Limit NMT 2 caps should deviate from avg wt. </li></ul></ul><ul><ul><li> AVG WT %DEVIATION </li></ul></ul><ul><ul><li> <300mg 10% </li></ul></ul><ul><ul><li>>300mg or more 7.5% </li></ul></ul>
  16. 17. <ul><li>For soft gel caps: </li></ul><ul><ul><li>Wg 10 caps </li></ul></ul><ul><ul><li>Remove inner content by cutting with scissor/blade </li></ul></ul><ul><ul><li>Wash with solvent & evaporate solvent at room </li></ul></ul><ul><ul><li>temperature for 30 min </li></ul></ul><ul><ul><li>Wg the empty shells & calculate % deviation </li></ul></ul><ul><li>MACHINE OUTPUT INSPECTION: </li></ul><ul><li>Machine output is monitored in a specific time interval </li></ul><ul><li>Total batch or number of caps filled are counted in a </li></ul><ul><li>specific time interval & then machine is calibrated and </li></ul><ul><li>speed is maintained. </li></ul>
  17. 18. <ul><li>APPEARANCE: </li></ul><ul><li>Inspection of capsules checked with a standard strip </li></ul><ul><li>SORTING DEFECTS: </li></ul><ul><li>Electronic automated or manual inspection is made to sort out & reject the defected caps. </li></ul><ul><li> Overprinting </li></ul><ul><li>PRINTING & LABELING: </li></ul><ul><ul><ul><li>Inspection of overprinting, logo, labeling are checked with the standard shade cards. </li></ul></ul></ul><ul><ul><ul><li>Defective ones are sorted out & rejected. </li></ul></ul></ul>
  18. 19. LOZENGES Que- Are they different from Tablets? Ans- Yes..
  19. 20. Steps For Manufacturing Of Lozenges <ul><ul><li>Weighing </li></ul></ul><ul><ul><li>Mixing </li></ul></ul><ul><ul><li>Sifting </li></ul></ul><ul><ul><li>Granulation </li></ul></ul><ul><ul><li>Moulding/Compression at low pressure </li></ul></ul><ul><ul><li>Packaging & Labeling </li></ul></ul>
  20. 21. IPQC Checks During Manufacturing <ul><li>Visual inspection </li></ul><ul><li>Shape, size, color </li></ul><ul><li>Weight variation </li></ul><ul><li>Overprinting logo </li></ul><ul><li>Uniformity </li></ul><ul><li>Disintegration </li></ul><ul><li>Packaging & Labeling </li></ul>
  21. 22. POWDERS
  22. 23. Types Of Powders <ul><li>Effervescent powders </li></ul><ul><li>Dusting powders </li></ul><ul><li>Insufflations (Inhalers) </li></ul><ul><li>Dentifrice </li></ul><ul><li>Oral powders </li></ul>
  23. 24. Flow Chart Of Powder Manufacturing
  24. 25. IPQC Checks During Powder Manufacturing <ul><li>Particle size & shape </li></ul><ul><li>Texture </li></ul><ul><li>Powder flow </li></ul><ul><li>Fluffiness </li></ul><ul><li>Density </li></ul><ul><li>Foreign Impurities </li></ul><ul><li>Moisture </li></ul><ul><li>Packaging </li></ul><ul><li>- sealing, printing </li></ul>
  25. 26. <ul><li>1. Effervescent Powders: </li></ul><ul><li>sample powder in 250ml of water produces </li></ul><ul><li>effervescence & dissolves in 12sec. </li></ul><ul><li>Dusting Powder: </li></ul><ul><li>color, texture, density, particle size, flow, fluffiness, spread ability </li></ul><ul><li>Insufflations: </li></ul><ul><li>flow, particle size, density </li></ul><ul><li>Dentifrice: </li></ul><ul><li>abrasion, texture, particle size, color </li></ul>
  26. 27. Powder Flow & Texture Analyzer
  27. 28. <ul><li>Powder Flow Analyzer used to measure: </li></ul><ul><ul><li>Flow </li></ul></ul><ul><ul><li>Texture </li></ul></ul><ul><ul><li>Caking </li></ul></ul><ul><ul><li>Cohesion </li></ul></ul><ul><ul><li>Flow Speed </li></ul></ul><ul><ul><li>Granule attrition </li></ul></ul><ul><ul><li>Compaction & Relaxation </li></ul></ul><ul><ul><li>Dusting </li></ul></ul><ul><ul><li>Surface Friction </li></ul></ul><ul><ul><li>Aggregation </li></ul></ul><ul><ul><li>Air-entrapment </li></ul></ul><ul><ul><li>Granulation </li></ul></ul>
  28. 29. Parameters Measured: <ul><li>(principle-slicing, shearing, compaction) </li></ul><ul><li>speed of rotor blade </li></ul><ul><li>blade angle </li></ul><ul><li>path of blade </li></ul><ul><li>resistance in speed and angle </li></ul><ul><li>axial force </li></ul><ul><li>time distance travelled </li></ul><ul><li>Measured by a sensitive transducer attached to rotor blades. </li></ul>
  29. 30. REFERENCES: <ul><li>WHO Guidelines For Good Manufacturing </li></ul><ul><li>Practices </li></ul><ul><li>2. Guidance For Industry: Nonsterile Dosage Forms; US Dept. of health & human services </li></ul><ul><li>3. Manohar A Potdar; current-Good Manufacturing Practices , Edn-2003. </li></ul><ul><li>D.H.Shah; standard operating procedures. </li></ul><ul><li>Satish Maliya; WHO Guidelines; Issue-Jan-19-22;2011. </li></ul><ul><li>WHO public inspection report of finished product manufacturing </li></ul>