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Presented by : Ravi.R Udhan M.Pharm ( Quality Assurance ) Ravi.firstname.lastname@example.org 9975541775 1PowerPoint Presentation: 2 Content’s Definition of validation Scope of Validation Importance of Validation Types of Validation Various regulatory requirements for validation Organization for Validation Documents required Qualification Process validation ReferencesPowerPoint Presentation: Validation “ A documented programme, which provides a high degree of assurance that a specific process will consistently produce ,a product meeting its pre-determined specification and quality attributes’’. 3 DefinitionPowerPoint Presentation: Scope It is very vast area and difficult to explain the scope of validation. Validation system includes Analytical method validation Instrumental calibration Equipment validation Manufacturing operation Cleaning validation Training validation Vendor validation Process validation 4PowerPoint Presentation: Importance of Validation Reduction of quality cost Process optimization Assurance of quality Safety 5PowerPoint Presentation: Reduction of quality cost It includes Preventive cost :- means cost incurred in order to prevent failure which includes Quality planning Calibration Documentation Monograph Annual review 6PowerPoint Presentation: B.Appraisal cost :- It consist of cost Inspection Testing Packaging 7 Reduction of quality costPowerPoint Presentation: Reduction of quality cost C. Internal failure cost :- Means cost of material that does not meet quality standard which includes Rejects Re-inspection Retest Wastage Sorting Substandard material D . External failure Cost :- It includes Recalls Complaints 8PowerPoint Presentation: Process Optimization Means to make process effective, useful, as possible at minimum cost. Some areas where experience shows that optimization is possible as a result of validation studies are the following … Optimum batch size relative to avaibility of equipment and personnel. Reduced sterilization time. Reduced mixing time. Faster and more accurate analytical test procedures. Reduces energy cost e.g. well calibrated temperature gauges . 9PowerPoint Presentation: 10 Assurance of Quality SafetyPowerPoint Presentation: Types of Validation Analytical method Validation 2.Raw Material Validation 3.Cleaning validation 4.Calibration 5.Process Validation Retrospective Validation Concurrent Validation Prospective validation Revalidation 11PowerPoint Presentation: 6.Equipment validation Design Qualification Installation Qualification Operational Qualification Performance qualification Types of Validation 12PowerPoint Presentation: Various regulatory requirements for validation Role of FDA It is federal science based law enforcement agency mandated to protect public health. Validation process regulated by guidelines & restriction set forth by FDA. However the actual validation protocol , document & execution is responsibility of manufacturer, more specially this is responsibility of engineer. 13PowerPoint Presentation: Various regulatory requirements for validation 2. CFR ( Code of federal Regulation ) “ This is body of regulation created by government, that set forth the guidelines pertaining to food & drug’’ CFR Part Covers 21.CFR part 210 Concerns current good manufacturing practices in mfg, processing, packaging of drug. 21.CFR Part 211 Concerns cGMP for finished pharmaceuticals 21. CFR part 600 Concerns to production of biological derived product 21. CFR pat 610 Safe distribution of biological derived product 14PowerPoint Presentation: Organization for Validation It is not a responsibility of single personnel It includes qualified expertise from following department Production department Quality assurance department Quality control department Research and development Engineers Others 15PowerPoint Presentation: Types of Document required Validation Master plan ( VMP) Validation protocol Validation reports Standard operation procedure 16PowerPoint Presentation: Importance of documentation Clearly identifies process Clearly identifies responsibities of performing validation Conduction of validation in accordance with prepared and approved protocol Clearly record result & conclusion presented in written validation report Process & procedure should established on the basis of these result 17PowerPoint Presentation: Validation Master Plan “ validation master plan is internally approved document that describes , in clear and concise wording, the general expectations , intentions, method & approach to be used during entire validation plan.” 18PowerPoint Presentation: Validation Master Plan Not a such legal requirements. However the FDA inspector do demand copy of validation master plan to see. The ides of this document is to show the FDA inspector that the company has highly organized approach to the validation programme. Validation master plan may contain Table of content Approval page Introduction & objective Facility and process description Personnel , planning & scheduling 19PowerPoint Presentation: Validation Master Plan 6. Responsibilities of validation team member 7. Equipment, apparatus, process & system qualification reports. 8. Cleaning validation report 9. HVAC validation report 10.Water system 11.Training documentation 12 .Acceptance criteria 20PowerPoint Presentation: Validation protocol Essential for step by step validation It ensures that process is adequately validated It consist of…………….. Identification of process to be validated Identification of devices required Objective Length & duration of validation Shifts & operator description Qualification of utilities Complete description of process Process parameter & method monitoring parameter Consideration of maintenance & repairs Criteria for revalidation 21PowerPoint Presentation: Qualification “ Action of proving that any premises, system and items of equipment work correctly and actually lead to the expected result.” 22PowerPoint Presentation: Parts of Qualification Design qualification Installation qualification Operational qualification Performance qualification 23PowerPoint Presentation: Design qualification If we are going to purchase an equipment which is a standard equipment then the preparation of design qualification does not become vary important because we are accepting manufacturer design as it is. It is advisable to work out the detailed equipment specification by sitting together with equipment manufacturer. DQ is done with consideration of URS. Generally factory acceptance test (FAT) is perform at manufacturer premises before dispatch of equipment to purchaser. 24PowerPoint Presentation: Example of Design qualification protocol for HVAC system Sr.no Description of specification Acceptance criteria User requirement specification 1 Room size in meter 5.3l*4.8w*3.1h 2 Cleanliness class 100/1000 3 RH to be maintained 45± 5% 4 Room pressure ( mm of water) 6 5 Air change per hour 50 6 Return air Low level pick up riser 7 Differential pressure Magnehelic gauge Design accepted by Name /sign/date 25PowerPoint Presentation: Installation Qualification ( IQ) “ Documented Verification that all key aspect of installation adhere to manufacturers recommendation, appropriate codes and approved design qualification.” Simply put installation qualification means installed correctly IQ consideration includes Equipment design features ( material of construction) Installation conditions Calibration Safety features Supplier documentation points, drawing & manuals. Software documentation Spare part list Environmental condition criteria 26PowerPoint Presentation: Content of protocol of installation qualification Approval page System description Statement of purpose S.O.P’s Calibration Review Installation checklist Inspection checklist Drawing Material of construction Supporting Utilities Manufacturers certification Deficiency and corrective action report Final report 27PowerPoint Presentation: Operational Qualification Operational qualification may be defined as “Documented verification that the system or subsystem perform as intended through all specified operating range” OQ Consideration Process control limits (Time,Temperature,Pressure,Setup) Software parameter Material handling requirements Process change control Training Long term stability, capability of process Potential failure mode, action levels 28PowerPoint Presentation: Alarm tests Behavior of the system after energy breakdown Accuracy of filling lines Transportation speed in a sterilization tunnel Temperature distribution in an autoclave Performance of a washing machine Accuracy of a weighing system Examples of OQ 29PowerPoint Presentation: Performance Qualification In this phase the key object is to demonstrate the process which consistently produce acceptable product under normal operating conditions . PQ Consideration Long term process stability Long term process capability Challenge testing Actual process and process parameter I.P.Q.C 30PowerPoint Presentation: 31PowerPoint Presentation: 32PowerPoint Presentation: PROCESS VALIDATION 33PowerPoint Presentation: Definition “ Process validation (P.V) may be defined as- “ a documented programme which provides a high degree of assurance that a specific process will consistently produce a product, meeting its pre-determined specification and quality attributes.” Process validation starts only after the complete qualification programme of facilities and equipment is over. 34PowerPoint Presentation: Types of process validation 35PowerPoint Presentation: Prospective Validation Prospective validation means validation done during the product development stage. When we develop a new manufacturing process each step in new process is required to be established that it will give us desired result. During this step the input resources are selected and clearly specified, e.g. -material Specification is Cleary defined -equipment and process parameter are defined -operating condition if any is specified -level of training of people can also be define d 36PowerPoint Presentation: That means profile of all input and operating parameter both are decided and recorded. Output is studied and specification are defined Specification will consistent after repeated experiment Limit of variation of process parameter is identified The laboratory batch is scaled up to pilot batch The pilot batch is scaled up to 10 times to produce commercial batch During this batches the specification, variables and process parameter are defined. Then product is handed over to manufacturing. Prepare documentation of all batches. Prospective Validation 37PowerPoint Presentation: Concurrent Validation Concurrent validation is validation which is carried out during production. When, after 3 initial commercial batches are taken and process is handed over to manufacturing personnel; verification of process parameter still goes on. The process parameter is evaluated for manufacturing facilities batch after batch and studied if any change or deviation is observed or required. I.PQ.C test for regular production are performed. 38PowerPoint Presentation: Revalidation Revalidation is rule required under following circumstances. Change of formula. equipment, procedures or quality of raw materials, even physical variation of raw materials like bulk density, particle size etc. Major changes to process parameters. E.g. dry heat sterilization in batch sterilizer to continuous dry heat sterilization in a tunnel sterilizer will demand revalidation. Changes to facilities and installation which influences the process. On appearance of negative quality bonds e.g. a tablet formation consistently showing increased disintegration time etc. Or liquid preparation showing either low or high ph consistently 39PowerPoint Presentation: Revalidation Revalidation is rule required under following circumstances. Change of formula. equipment, procedures or quality of raw materials, even physical variation of raw materials like bulk density, particle size etc. Major changes to process parameters. E.g. dry heat sterilization in batch sterilizer to continuous dry heat sterilization in a tunnel sterilizer will demand revalidation. Changes to facilities and installation which influences the process. On appearance of negative quality bonds e.g. a tablet formation consistently showing increased disintegration time etc. Or liquid preparation showing either low or high ph consistently 40PowerPoint Presentation: Retrospective validation Retrospective validation may be defined as, "establishing documented evidence that a system does what if purpose to do based on review and analysis of historical data and information obtained during marketable product.” Retrospective validation may be allowed, when the formulation procedure and equipment have not be altered. 41PowerPoint Presentation: Phases of process validation Process design /process development Process qualification Design of facility Qualification of utilities & equipment Process performance qualification (PPQ) PPQ protocol Process execution and report 3.Process verification 42PowerPoint Presentation: Process development Process development activities begin after the formulation has been developed. The process development program meet the following objectives. Develop a suitable process to produce a product which meets all a. product specification b. current good manufacturing practices 2.Identify the key process parameter that affect the product attribute. 3.Identify in process specification 43PowerPoint Presentation: Process development stages 44PowerPoint Presentation: Typical Process flow granulated product 45PowerPoint Presentation: Influence matrix 46PowerPoint Presentation: Process step Control variables Measured responses Preblending Blending time , rpm , load size Blend uniformity Granulating Amount of granulating agent Load size & rpm ,g ranulation time Density Drying Initial temp, air flow program, Drying time, cooling time Density Moisture content Sizing Screen type, feed rate Granule size distribution Loose density Blending Load size , rpm , blending time Flow characteristics Tableting Compression rate, Compression force, granule Feed rate Weight variation Hardness ,Thickness Disintegration and dissolution time Typical variable and responses of granulated product 47PowerPoint Presentation: References Pharmaceutical Process Validation, third edition, by R.A Nash , Marcel and Dekker publication, page no-20-47 Guidance for pharmaceutical industry on process validation, USFDA, January 2011,reision-01 Quality assurance of pharmaceuticals , Good manufacturing practices and inspection, second edition , vol-2 , WHO , PharmaMed Press, page no-101-120 Pharmaceutical Quality Assurance, second edition, by M.A Potdar , nirali prakashan, page no 8.1-8.44 Remington, The science and practices of pharmacy,21 st edition, kluwer health publication, page no-900-9013 48PowerPoint Presentation: THANK YOU 49 You do not have the permission to view this presentation. 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