Published on October 20, 2012

Author: piyu_3



PowerPoint Presentation: VALIDATION OF EQUIPMENT VALIDATION OF TABLET COMPRESSION ( MACHINE) PRESENTED BY : MISS.PRIYANKA VORA M.PHARM 3 rd SEM (Q.A) 2012-13 Validation and Product Development C.U.SHAH COLLEGE OF PHAMACY AND RESEARCH WADHAWAN . Your Topic Goes Here: Your Topic Goes Here Your subtopic goes here CONTENT :- Definitions General Introduction Of Qualifications Introduction Of Comprssion machine Installation Qualification Comprssion machine (IQ) Operation Qualification Comprssion machine (OQ) Performance Qualification Comprssion machine (PQ) Validation Protocol Of Comprssion machine Referances Questions? PowerPoint Presentation: Definitions :- 1 ) Validation : Establishing documented evidence with provides a high degree of assurance that a specific process will consistently produce a product meeting its pre- determined specifications and quality attributes. 2) Calibration : The process quantitatively defining system responses to known controlled signal output. Purpose of Validation : Purpose of Validation Method is suitable for its intended purpose to get consistent, reliable and accurate data. Identification of Sources and Quantization of Potential errors Satisfy FDA Requirements Establish Proof that a Method Can be Used for Decision Making Your Topic Goes Here: Your Topic Goes Here Your subtopic goes here Cont : Advantages : Advantages Increased output Reduction in rejections and reworking cost effective Avoidances of capital expenditures Reduced testing in-process and in finished goods Easier maintenance of equipment When should be validated : When should be validated Change in established method New method developed for a particular problem Established method used in different laboratories, different equipment or different staff Out-of-control situations within internal quality assurance Demonstration of equivalence between two methods (e.g. a rapid new test against a standard method) PowerPoint Presentation: General Introduction Of Qualifications Qualification : The action of proving that any equipment Works correctly and leads to the expected results. It is devided into four types : INSTALLATION QUALIFICATION : The equipment installation is the qualification of equipment as it is to be installed. This qualification envolveos the coordinante efforts of the vender, the operating department , and the Project team that will provide input into the purchase, installation, operation and the maintenance of the equipment. Once the prequalification is completed, the efforts move to owner’s plant. The installation area should be reviewed to verify that it is in accordance with the specification. PowerPoint Presentation: Cont: 2) OPERATION QUALIFICATION : On completion of installation of the equipment at the final processing site and of the installation qualification document, a complete equipment operation qualificatin must be performed. The equipment operation qualification protocol should describe all aspects of the testing of equipment in detail. 3) PERFORMANCE QUALIFICATION : This phase will see the engineering function coming to a close with the various engineering and validation sign offs. The validation function will allow the project to move closer to final close-out and transfer of the entire project to the project coordinator or operating department E.g. validation of sterile area . PowerPoint Presentation: Cont : 4) Design qualification : Design qualification is defined as: “Providing documented evidence that the design of the facility and equipments meet the requirements of the user specification and GMP”. The purpose of the Design Qualification (DQ) is to define the functional specifications of the system and document the vendor selection process. PowerPoint Presentation: Introduction Of Comprssion Machine : Compression is a critical step in the production of a tablet dosage form. The materials being compressed will need to have adequate flow and compression properties. Factors to consider during compression are as follows: i)Tooling ii)Compression speed PowerPoint Presentation: Installation Qualification Of Comprssion machine (IQ) Verity approved purchase order. Verity invoice Check manufacturer and supplier. Verity model number and serial number. Check for any physical damage. Conform location and installation requirements per recommendation of manufacturer. Verify that the required utilities are available. Installation shall be conducted per instructions provide in the manual. PowerPoint Presentation: Objective of IQ: Objective of IQ: TO Check all the critical contact parts which directly affect quality of the product either visually or by kit. To review proper installation as per checklist. To measure the dimension wherever possible. PowerPoint Presentation: Installation Qualification check list : Compare the all specification and write the observation Machine height - Measure with measuring tape Overall Dimension - Measure with measuring tape RPM of turret (max. & min.) - Check by tachometer Hopper Conventional hopper - by visually check MOC (Material of construction) - Using Molybdenum Kit Height - Measure with measuring tape 5) No. of station - Visually count no. of holes on turret 6) Type of tooling - Using Venire caliper check the die hole diameter PowerPoint Presentation: Cont: 7 ) Turret MOC – by visual check Circumference – Measure with measuring tape Distance between two dies - Using Venire caliper Feeder - by visual check Main electrical motor HP – Visually check by reading plate affixed on motor RPM - Visually check by reading plate affixed on motor or Direction of motor (anti clockwise) - by visual check Required Utilities i ) Electricity - by visual check PowerPoint Presentation: Cont: 11 ) Thickness controller cam 12) Weight controller cam 13) Emergency switch 14) Dust Extraction and exhaust System Main drive Available ON Indicator By visual Potentiometer check Selector switch Emergency OFF button 16) Lubrication Oil pressure gauge Selector switch for Auto/ Manual PowerPoint Presentation: Operation Qualification Of Comprssion Machine (OQ) Verify alarm control. Perform calibration requirements, identified in the manual or established by the validation team. Operate the equipment at low ,medium and high speed per operation manual to verify the operation control. Verify that all switches and push buttons are functioning properly. Establish procedures for operation, maintenance and calibration Establish training program for relevant staff. Run one pilot batch for each product PowerPoint Presentation: Objective of OQ : To operate machine as per proposed procedure given in manual and record. To challenge the operating parameters of machine and record. To challenge the safety operation and record. PowerPoint Presentation: Operational qualification check list : Compare the all specification and write the observation Main Switch – Check visually by operating the main switch of the machine . 2) Start push button – (illuminated Green switch)By pressing start button the Green switch glows and the main drive motor should start. 3) Stop push button - (illuminated red switch) By pressing stop button the red switch glows and the main drive motor should stop. 4) Turret RPM challenge test – set in digital table counter by rotating knob Check by tachometer Rotation direction ( clock wise) by visual check PowerPoint Presentation: Cont : 5)Emergency switch (Machine should be stop) 6) Selector/ isolator switch (Machine start/stop) By 7) Tablet thickness Visually & Hardness controls check By turning the swing lever to right (anticlockwise) thickness increased/ hardness decrease vise versa PowerPoint Presentation: Cont: 8 ) Tablet weight controls Dozer and wedge is moved clockwise Decrease / increase / Anti clockwise weight 9) Machine speed adjustment Release the locking knob and rotate increased speed / the hand wheel anticlockwise / clockwise decreased speed 10) Main upper punch entr y Remove the bolt and rotate the upper punch penetration Perforated Segment to Right / Left increase / decrease 11) Agitator controller i )Turn the agitator ON - Check by tachometer ii) Turn the knob and set the RPM 5 PowerPoint Presentation: Performance Qualification Of Comprssion Machine (PQ) Evalution of compressing capabilities and Tablet characteristics. The compressing capabilities and table characteristics (i.e. content uniformity , thickness , hardness , friability , weight variation and disintegration time) should be investigated . Objective of PQ: First three batches/product of bilary and single layer product to be compressed on given compression machine. All the critical physical parameters of the product will be checked during performance qualification. PowerPoint Presentation: Performance qualification check list : Compare the all specification and write the observation of all 3 batches Product name 10) Average weight of 20 Batch No Tablet Batch size 11) Individual Weight Product description variation Machine RPM 12) Thickness (mm) Punch detail 13) Hardness ( Kg/cm 2 ) Punch diameter Punch Shape Upper punch/ Lower punch PowerPoint Presentation: Validation Protocol Of Comprssion Matchine: 1)DISCRIPTION 1.1) Purpose and scope 1.2) Study for qualification and responsibility 1.3) Signature log 1.4) Training record 2) INSTALLATION QUALIFICATION 2.1) Equipment detail and description 2.2) IQ check list Table 2.3) Observed deviation during installation qualification 3) OPERATION QUALIFICATION 3.1) OQ training record 3.2) OQ procedure 3.3) OQ check list Table 3.4) Observed deviation during operational qualification 3.5) Recommendation and conclusion during PowerPoint Presentation: Cont : 4) PERFORMANCE QUALIFICATION 4.1) PQ Procedure 4.2) PQ with first , second and third batch 4.3) Observed deviation during performance qualification 4.4) Recommendation and Conclusion 4.5) Report approved by PowerPoint Presentation: REFERANCES : “Pharmaceutical process validation” an international 3 rd edition by Robert A. Nash, Alfred H. Wachter,2003 Marcel Dekker.INC 2) Agalloco James, Carleton J . Fredrick “Validation of Pharmaceutical processes” 3 rd edition. PowerPoint Presentation: ANy quEsTIOnS PowerPoint Presentation: Backdrops: - These are full sized backdrops, just scale them up! - Can be Copy-Pasted out of Templates for use anywhere! Title Backdrop Slide Backdrop Print Backdrop Additional Graphics: Scale them up or down! .GIF clipart is animated. .JPG clipart can be scaled up and take up little file space. .PNG clipart can be scaled unusually large without distortion. Transitional Backdrop

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