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  2. INTRODUCTION : 2 ⚫VALIDATION : Action of proving and documenting that any process, procedureor method actually and consistently leads to theexpected results. & ⚫QUALIFICATION : Action of proving and documenting that any premises, systems and equipment are properly installed, and/orwork correctlyand lead to theexpected results. The term qualification is normally used for equipment, utilities and systems, and validation for processes ⚫In this sense, qualification is partof validation.
  3. TABLET COMPRESSION MACHINE: 3 ⚫A tabletpress is a mechanical device thatcompresses powder into tabletsof uniform size and weight. ⚫Tablet Compression Machine is also known as Tablet Press in Pharmaceutical Industrywhich is used to make the tabletsaccording toa pre-determined design. ⚫Compression is a critical step in the production of a tabletdosage form. The materials being compressed will need to haveadequate flow and compression properties. ⚫Factors to beconsidered during compression are,  Tooling  Compressionspeed
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  5. TOOLING : 5 ⚫Tablet compression machines are made in keeping the view of the typeof diesand puncheswill be used on them, ⚫Thedies and punchesand theirsetupon compression machine is called tooling. ⚫The shape ,size and as well as certain identification markings are determined by compression machine tooling. ⚫Each tooling setconsistof dies , upperand lowerpunches. ⚫Productionefficiency, dosage uniformityand appearance depend upon tooling set.
  6. ⚫Punches : Length: Upperpunch - 5.25 inches Lower punch - 3 inches. Barrel diameter- 0.75 inches. Head diameter- 1 inch ⚫D tooling : Is popular for large tablets Punch: Length- 5.25 inch Head diameter- 1.25 inch Barrel diameter- 1 inch Dies : out side diameter – 0.945 inch are used 6
  8. INSTALLATION QUALIFICATION (IQ): 8 ⚫Verifyapproved purchaseorder. ⚫Check manufacturerand supplier . ⚫Verify Model numberand serial number. ⚫Check any physical damage. ⚫Confirm location and installation requirementsas per recommendation of manufacturer . ⚫Verify that the required utilitiesareavailable. ⚫Installation shall be conducted per instructions provide in the manual. OBJECTIVE OF IQ ⚫Tocheck all thecritical contacts parts which directlyaffect qualityof the product. ⚫To review proper installation as perchecklist.
  9. IQ CHECK LIST: 9 Compareall specification and write theobservation ⚫Machine height – measurewith measuring tape. ⚫Overall dimension- measurewith measuring tape ⚫Rpm of turret – check by tachometer. ⚫Hopper : i)Conventional hopper- by visual check ii)MOC(masterof construction )-using Molybdenum iii)Height- Measurewith measuring tape ⚫No. of station- visuallycount no.of holes on turret. ⚫Typeof tooling- using venire calipercheck thedie hole diameter . ⚫Feeder- byvisual check. Continue…
  10. ⚫Required utilities-electricity. ⚫Thickness controllercam ⚫Weightof controllercam ⚫Main drive : i) ON indicator ii) Potentiometer iii) SelectorSwitch iv) Emergency switch ⚫Dustextraction and exhaustsystem ⚫Lubrication i) Oil pressuregauge ii) Selectswitch forauto/manual By Visual check 10
  11. OPERATIONAL QUALIFICATION (OQ ): 11 ⚫Verify alarm control. ⚫Perform calibration requirements, identify in the manual orestablished by thevalidation team. ⚫Operate theequipmentat low mediumand high speed as per operation manual to verify the operation control. ⚫Verify thatall switchesand push buttonsare functioning properly ⚫Establish procedures foroperation, maintenanceand calibration ⚫Establish training program forrelevantstaff Runone pilot batch foreach product
  12. ⚫Objectiveof OQ : ⚫Tooperate machineas per proposed proceduregiven in manual and record. ⚫Tochallenge theoperating parameterof machineand record. ⚫Tochallenge the safetyoperation and record. 12
  13. OQ CHECK LIST: 13 1)Main switch- check visually byoperating the main switchof the machine. 2)Start push button- illuminated green switch By pressing start button thegreen switchglowsand the main drive motorshould start. 3)stoppush button- illuminated red switch By pressing stop button the red switch glows and the main drive motorshould stop 4)Turret RPM challenge test- set in the digital table counterby rotating knobcheck by tachometer Rotation direction (clockwise ) byvisual check Continue…
  14. OQ CHECK LIST: 14 5) Emergency switch byvisual check . 6)Tablet thickness & Hardness controls : By turning the swing lever to right/left thickness increased hardness/decrease vise versa 7)Machinespeed adjustment : Release the locking knob and rotate the hand wheel anticlockwise /clock wise- increased speed/decreased speed 8)Main upperpunch entry: Remove the bolt and rotate the perforated segment to right/ left-upper punch penetration increases/ decreases.
  15. PERFORMANCE QUALIFICATION (PQ): 15 ⚫Its an Evaluation of compression capabilitiesand tablet characteristics. ⚫Thecompression capabilitiesand tabletcharacteristics are: 1) Content uniformity 2) Thickness 3) Hardness 4) Friability 5) weightvariation 6) Disintegration test. should be investigated.
  16. OBJECTIVE OF PQ : 16 ⚫First three batchesof biliary and single layerproduct to becompressed on given compression machine. ⚫All thecritical physical parameters of productwill be checked during performance qualification. ⚫Measure the thickness, hardness, friabilityand weight foreach triplicate tabletrun, as shown below
  17. ⚫CONTENT UNIFORMITY : - Select 30 tablets randomly from batch - Assay individually ⚫ACCEPTANCE CRITERIA: - Outof 30 tablets 3 tabletscan be with in 75 – 125% and all tablets should bewith in 85 -115% ⚫THICKNESS : - First 20, last 20, middle 20 tablets (throughout the run) Determine mean and standard deviation. ⚫ACCEPTANCE CRITERIA: - The Relative Standard Deviation should be less than or equal to 5% 17
  18. ⚫HARDNESS : - First 20, last 20, middle 20 tablets (throughout the run) Determine mean and standard deviation for baseline ⚫ACCEPTANCE CRITERIA : -Must meeteach tablet specifications. Chewable tablets- 3kg/cm2 Tablets- 4-8kg/cm 2 sustained release tablets & troches- 10-20kg/cm 2 ⚫FRIABILITY: - First 20, last 20, middle 20 tablets % friability =( initial wt - final wt / initial wt ) ⚫ACCEPTANCE CRITERIA: - Weight loss less than orequal to 1%, per USP 18
  19. ⚫WEIGHTVARIATION: 20 - TABLETS % weightvariation= (individual wt-avg wt/ avg wt) x 100 ⚫ACCEPTANCE CRITERIA : ForAverage Weight 130 mg or less 10% difference For Average Weight 130 to 324 mg 7.5% difference For Average Weight More than 324 mg 5% difference Not more than two tablets haveavariationas largeas shown here. 19
  20. ⚫DISINTEGRATION TEST : It is the processof breakdownof tablet into smaller particles 20 TABLETS DISINTEGRATION TIME Uncoated 15 min Plain Coated 60 min Enteric Coated 3 hrs Dispersible 3 min Effervescent More than 3 min Sublingual 4 hrs Buccal 4hrs
  21. ACCEPTANCE CRITERIA: ⚫All tablets havedisintegrated completely. ⚫If 1 or 2 tablets fails todisintegratecompletelyrepeat the test for 12 additional tablets. 21
  22. VALIDATION/QUALIFICATION OF CAPSULE FILLING MACHINE 22 Installation Qualification(IQ) The Installation Qualification will confirm details from ⚫theengineering specifications, ⚫equipment purchaseorder ⚫cGMP guidelines and requirements, verify that theequipment has been installed as specified by thevendor
  23. Purchase Details : ⚫The purchaseorder no. date shall be checked ⚫The accessories theirspare parts if any shall bechecked as perpurchaseorder ⚫Thedelivery period shall beas perpurchase order ⚫Supplieror manufacturer nameaddress shall be checked ⚫Anydeviation observed should be informed to the supplieror manufacturer 23
  24. ⚫Detailsof the Equipment : ⚫Equipment name, make model no. shall be recorded ⚫In-house identification no. shall be recorded ⚫Location for installationshall be checked ⚫Utilities required shall be listed down ⚫A detailed specification must bewritten which highlight thosepartsof machine thatare in productcontact ⚫Where stirring devicesoraugers are used toensure homogeneityand improve flow then specification of these parts must be checked 24
  25. ⚫Acceptance Criteria ForIQ : ⚫Fulfill the selection criteria its purposeof Application ⚫Theequipmentshall beas per purchaseorder ⚫Accessories received shall be as perpurchase order ⚫Should meetpre-selected design parameters ⚫Manufacturer/suppliershall providecomplete equipment manual ⚫Material of constructionshall beas perpurchaseorder 25
  26. Operational Qualification (OQ) 26 ⚫Before initiating OQ ensure that SOP for operation and Cleaning of Capsule Filling Machine is available. ⚫Purpose is to train the qualification team for performing OQ Procedure : ⚫Check all the dynamic attributes of the capsule filler conform to the required specifications ⚫Initiate the actual operation of the equipment to ensure that machine is operate within the desired rate of output. ⚫The operation of indicators, controls and alarms is verified ⚫Oil leaks that could contaminate the process are observed
  27. Acceptance criteria For OQ : 27 ⚫All operating inputs provided on theequipment when tested shall-successfully comply -meet tolerance limit ⚫Theequipmentshould successfully performwhen operated as per SOP ⚫Critical alarm/indicators provided on the equipment- -calibrated ⚫Theequipmentwhen operated shall not - produceabnormal sound - show anydiscrepancy in its smooth operation.
  28. Performance Qualification(PQ) 28 ⚫PQ activities demonstrates and documents that the equipment is able to perform its intended functions within thevariable process limits fora specific product ⚫Acceptance criteria are developed according to the regulatoryrequirementsand production parameters ⚫To ensure that thequalityand purityof the product is maintained ⚫The PQ will also test theextremesof theoperation, or the peak load conditions, but it does not include testing to failure.
  29. ⚫Procedure : ⚫Record the numberof damaged capsules ⚫Capsules from throughoutthe lot/different batches should be tested forweight uniformity ⚫Capsules from throughout the lot/different batches should be tested for blend contentuniformity ⚫Production speed i.ecapsuleper minuteshould be evaluated 29
  30. THAN K YOU ! 30