Validation profile sahil

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Validation profile sahil

  1. 1. Seminar on VALIDATION PROTOCOLS GUIDED BY: PRESENTEDE BY: SAHILHUSEN I . JETHARA M. PHARM – I (2013-14) ROLL NO. - 02 Dr. M. R. PATEL Principale & HOD in pharmaceutics DEPARTMENT OF PHARMACEUTICS SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND REASERCH, MODASA-2013 SHRI BMCPER, MODASA NIKITA 1 1
  2. 2. LIST OF CONTENTS………  INTRODUCTION  TABLETS  PHARMACEUTICAL  ORAL POWDERS LIQUID  SEMISOLID SHRI BMCPER, MODASA NIKITA DOSAGE FORM 2
  3. 3. INTRODUCTION VALIDATION  It is a documented programme which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications & quality attributes. Why validation is required?   Manufacturers require by law to conform to cGMP. To avoid possibility of rejected or recalled batches. - To ensure the product uniformity , reproducibility, & 3 quality
  4. 4. Validation Protocol It gives Details of the critical parts of the of the manufacturing process.  Information about the key parameters that are to be measured.  Allowable range of variability in case of measured parameters.  The manner in which the system will be tested.  4
  5. 5. Types of validation  Prospective Validation:- an experimental protocol is run before starting of actual use.  Concurrent Validation:-In process monitoring of critical processing steps & end product testing of current production  Retrospective Validation:-It is chosen for established  products where their manufacturing processes are considered to be stable ( i.e. long history state of control) Validation is done for.:- a) Raw materials b) Process c) Product. 5
  6. 6. TABLETS It is unit solid dosage forms containing drug substances with or without suitable diluents and prepared by compressing powdered or granulated medicinal substances in die. SHRI BMCPER, MODASA NIKITA 6
  7. 7. Validation  IN CASE OF TABLETS IT IS DONE FOR:1. 2. 3. 4. RAW MATERIAL PROCESS PRODUCT FINISHED PRODUCT SHRI BMCPER, MODASA NIKITA 7
  8. 8.  RAW MATERIAL VALIDATION:Raw material is validated for particle size, surface area, particle size distribution, colour , Appearance, texture, density, flowability , compressibility etc PROCESS VALIDATION:Two stage  First identify the critical process parameter and design protocol  Manufacture three batches of product controlling the critical parameter and test it for compliance 8 SHRI BMCPER, MODASA NIKITA
  9. 9. SHRI BMCPER, MODASA NIKITA 9
  10. 10. PRODUCT VALIDATION:1. 2. 3. 4. 5. 6. Raw Material Packaging Material Granules Compressed Tablets Coated Tablets Packed Final Product FINISHED PRODUCT VALIDATION:1. ORGANOLEPTIC PROPERTY 2. PHYSICAL CHARACTERISTIC 3. CHEMICAL CHARACTERISTIC 4. BIOLOGICAL CHARACTERISTIC 5. MICROBIOLOGICAL CHARACTERISTIC 6. STABILITY TESTING 7. STORAGE CONDITION SHRI BMCPER, MODASA NIKITA 10
  11. 11. PHARMACEUTICAL POWDERS API + EXCIPIENT (BOTH ARE IN POWDERED FORM) POWDER DOSAGE FORM  Powder are homogeneous mixture of drug/drugs and excipient/excipients in a dry, fine state of subdivision.  It is important to note that term" POWDER” is restricted only to “POWDERS FOR INTERNAL USE ONLY”.  But not used for other powder mixtures. For EX. like powder for external use they rather called as “Dusting powders”. 11 SHRI BMCPER, MODASA NIKITA
  12. 12. POWDERS AS A PRIMARY REQUIREMENT FOR DOSAGE FORM 12 SHRI BMCPER, MODASA NIKITA
  13. 13. VALIDATION 1. Validation of Raw material 2. Validation of Blending Equipments 3. Validation of Blending operation 4. Validation of final packed material SHRI BMCPER, MODASA NIKITA 13
  14. 14. 1. VALIDATION OF RAW MATERIAL Physical characteristics of raw material can vary among manufacturers of drug substances. Inspection should cover the firm’s data for the specification for drug substances. RAW MATERIAL SPECIFICATION  Description, identification, melting range, ph, water, residue on ignition, chloride, sulfate, sulfide, heavy metals, readily carbonizable substances, total aerobic microbial count, mould and yeast count, E. Coli, acceptable container, approved expiry date, approved suppliers. 14
  15. 15. 2. VALIDATION OF BLENDING EQUIPMENTS        What is the working capacity of equipment? Does the equipment operate more efficiently with the density of fluffy powders? What is the working load range, i.e. the proper blender load to ensure good uniformity of blend? What feature does the equipment have for ease of handling of powders, automated charging and discharging Can the equipment heat the powder blend if needed for application as a dryer as well as a granulator? Is the method of heating electric or steam? May a vacuum be used with the equipment? Does the equipment have the capacity to wet the powder blend? 15
  16. 16. 3. Validation of Blending operation        Determination of the optimum blending time De-mixing or segregation Verification of homogeneity of mixed powders Interaction between process & material Validation of characteristics of blend. -Bulk density -Particle size distribution -Moisture content Load size in blending apparatus Powder flow 16
  17. 17. 4. Validation of final packed material  Checking integrity of foils  Checking integrity of sealing  Checking opening ease  Permeability of foils 17
  18. 18. Classification
  19. 19. 1. PROCESS VARIABLES 2. PRODUCT VALIDATION SHRI BMCPER, MODASA NIKITA 20
  20. 20. 1. Process Variables Process Equipments Process variables Mixing of Kettle & Tank fitted with agitator Capacity of unit, Shape & position of agitation system, Order of addition, Rate of addition, Fill volume, Mixing speed of agitator, Temperature of liquid, Mixing time. liquid Properties affected by variables Appearance of liquid, Viscosity of liquid. Monitoring output Potency, Appearance, pH, Viscosity, Specific gravity.
  21. 21. Process Equipment Process variables Properties affected by variables Monitoring output Dispersing Homogenizer, Colloid mill, ultrasonic device Bore opening/ clearance of rotor & stator/power setting, Pressure/rotor speed/power consumption, Feed rate, Temperature, Dispersion time, Order of mixing. Particle size of solids, Viscosity of liquid. Potency, Particle size Distribution, Viscosity, Specific gravity.
  22. 22. 2. PRODUCT VALIDATION Major test parameters used for final product testing Appearance pH Viscosity Specific gravity Microbial count Leakage test for filled bottle (By plastic vacuum dessicator) Check the cap sealing Fill volume determination Particulate matter testing Water vapour permeability test Stress test
  23. 23. Test parameters specific for suspension • • • • Sedimentation rate Resuspendibility Particle size & particle size distribution Zeta potential measurement Type of emulsion determination by • • • • • • Dilution test Conductivity test Dye solubility test COCl2 filter paper Fluorescence test Direction of creaming Test parameters specific for solution • Clarity of solution • Color of solution
  24. 24. Semisolid Dosage Form 25 SHRI BMCPER, MODASA NIKITA
  25. 25. SHRI BMCPER, MODASA NIKITA 26
  26. 26. Process validation protocol  Contents 1. Protocol Approval Objective Scope Validation Approach Document Required List of Equipments Product Detailed Parameter to be tested Sampling plan Acceptance Criteria 2. 3. 4. 5. 6. 7. 8. 9. 10.
  27. 27. ABC Pharmaceuticals. 27, Mahalaxmi Estate, Vatva, Ahmedabad. Name Prepared By Checked By Approved By Designation Signature
  28. 28. ABC Pharmaceuticals. 27, Mahalaxmi Estate, Vatva, Ahmedabad. 5. Document required Document Effective Date Ref. No. MFR BMR BPR Test data sheet 6. List of equipments Prepared by Checked by
  29. 29. ABC Pharmaceuticals. 27, Mahalaxmi Estate, Vatva, Ahmedabad. 7. Product detailed        Generic name: Brand name: Product description: Dosage form: Labeled claim: Category: Composition with specification: Prepared by Checked by
  30. 30. ABC Pharmaceuticals. 27, Mahalaxmi Estate, Vatva, Ahmedabad. 8. Parameters to be tested Process stage 1) Mixing Process variable Validation response Mixing time Mixing rate Mixing temp. →By assay →Consistency Test Filling rate Speed →Weight variation →Sealing temp. →Pressure, Crimping →Coding. a) b) c) 2) Filling a) b) Prepared by Checked by
  31. 31. ABC Pharmaceuticals. 27, Mahalaxmi Estate, Vatva, Ahmedabad. 9. Sampling plan Process Stage 1) Mixing No. of sample taken 2 Qty of sample taken 2) Filling Prepared by Qty Test 30 gm from each location Test Equivalent to no of filling station Checked by
  32. 32. ABC Pharmaceuticals. 27, Mahalaxmi Estate, Vatva, Ahmedabad. 10. Acceptance criteria Stage Tests 1) Mixing Assay of ingredients Consistency test 2) Filling Spread smoothly & homogeneously FOR 15 gm Wt of empty tube Wt of filled tube Net content Crimping Coding Sealing Sealing temp. Air trapping Pressure Assay of ingredients Prepared by Acceptance Criteria Legible Straight & Smooth Complete & Leak proof 280°C – 300°C Free from air bubble 3.5 – 4.0 Kg/cm2 Checked by
  33. 33. REFERENCES  Pharmaceutical process validation by Loftus and.Nash SHRI BMCPER, MODASA NIKITA 34
  34. 34. Ph. No. :- +918460378336 Address:- 44, Assiyana Society; Dugarvada Road, Taluko & City : Modasa State: Gujarat Country: India Email: sahil.pharm4@gmail.com BEST OF LUCK TO ALL . . . . . . . . . . SHRI BMCPER, MODASA NIKITA 35
  35. 35. SHRI BMCPER, MODASA NIKITA 36

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