Process Validation

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Nice presentation. I would appreciate a copy to [email protected] for training. Thanks

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Presentation Transcript

Slide 1: 

QUALITY ASSURANCE DEPT WELCOME BY SRI QUALITY ASSURANCE PROECESS VALIDATIONS IN APIs

DEFINITION - VALIDATION : 

QUALITY ASSURANCE DEPT; API DEFINITION - VALIDATION Validation word derived from ‘valid’ which means “can be justified or defended”. Definition: “Validation is an established documented evidence which provides high degree of assurance that a specific equipment, process, method or system will consistently produce results meeting its predetermined specifications and quality characteristics”.

VALIDATIONS : 

QUALITY ASSURANCE DEPT; API VALIDATIONS validation is the documentation of all the knowledge, which provides assurance that the process performs as intended. In terms of Quality philosophy , “Validation is defined as a “prevention-based activity”. Validation is a proactive tool of Quality Assurance activity.

VALIDATION : 

QUALITY ASSURANCE DEPT; API ‘Ken Chapman’ quoted as … “Validation is not a destination, it is a never ending journey…. VALIDATION

TYPES OF VALIDATIONS : 

QUALITY ASSURANCE DEPT; API TYPES OF VALIDATIONS Others: Software validation Chemist validation System validation etc..

PROCESS VALIDATION : 

QUALITY ASSURANCE DEPT; API PROCESS VALIDATION Definition : “ It is an establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.” Q7A 12.4 : “Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an intermediate or API meeting pre-determined specifications and quality attributes.”

OPTIONS OF PROCESS VALIDATION : 

QUALITY ASSURANCE DEPT; API OPTIONS OF PROCESS VALIDATION PROCESS VALIDATION

DEFINITIONS : 

QUALITY ASSURANCE DEPT; API DEFINITIONS 1. PROSPECTIVE PROCESS VALIDATION “Establishing documented evidence that a process does what it purports to do based on a Pre-planned Protocol” 2. RETROSPECTIVE PROCESS VALIDATION “The retrospective process validation is an established documented evidence that a process what it purports to do ‘based on review and analysis of Historical data’.” 3. CONCURRENT VALIDATION. “Established documented evidence that a process does what it purports to do based on information generated during actual implementation of the process in according with a pre-planned protocol”.

PROSPECTIVE PROCESS VALIDATION : 

QUALITY ASSURANCE DEPT; API PROSPECTIVE PROCESS VALIDATION Prospective process validation shall be carried out before the Process is commercialization. Minimum 3 consecutive batches to be considered. The important requirement for the validation is the ‘protocol preparation’ Protocol shall be designed and get it approval from authorized management before starting the process validation. “ the protocol is a written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment and decision points on what constitute acceptable test results”.

PROSPECTIVE PROCESS VALIDATION : 

QUALITY ASSURANCE DEPT; API IDENTIFICATION OF CRITICAL STEPS Identification of critical steps and critical parameters is also one of the important step. Critical step: “A step which will affect on intended drug substance characterization is called critical step” “It is a step after which recovery from process malfunction or contamination is not possible” PROSPECTIVE PROCESS VALIDATION

Slide 11: 

QUALITY ASSURANCE DEPT; API STEP WISE APPROACH – CRITICAL STEP Usually critical if: Narrow range High probability of deviation Deviation likely to impact quality of the API

Slide 12: 

QUALITY ASSURANCE DEPT; API Critical Parameter Variable? Fixed Define Proven Range Define Operating Range Limit Critical? No Critical Limits Critical Limits No Yes No Yes The Approach

Examples of Process Parameters : 

QUALITY ASSURANCE DEPT; API Temperature Pressure Vacuum Time (Duration) Flow Rate Cooling Rate Agitation Speed Quantities of materials Order of addition Equipment type / material of construction Sequence of unit operations …. Examples of Process Parameters

PROSPECTIVE PROCESS VALIDATION : 

QUALITY ASSURANCE DEPT; API IDENTIFICATION OF CRITICAL STEPS: Who is responsible to identify critical step? Should it be R&D, Process Engineering, or Production? … there is no universal solution for this question…. But one can identify, who possess technically thorough knowledge about the process. “The process is a system that includes people, material, equipment and procedures each of these elements must be qualified”. PROSPECTIVE PROCESS VALIDATION

PROSPECTIVE PROCESS VALIDATION PROTOCOL : 

QUALITY ASSURANCE DEPT; API PROSPECTIVE PROCESS VALIDATION PROTOCOL Detailed chemical synthesis of product. List of Approved Vendors. Reference of R &D and Pilot scale up studies and technology transfer report. Detailed manufacturing instructions. List of equipment using for manufacturing process.(Equipment lay out) Reference of Equipment qualification details. Identification and description of critical process steps and critical parameters. Scientific rational for critical process steps and critical parameters. Sampling and testing plans. Validated analytical methods for In-process and final product testing. Statistical techniques to be used in data analysis. Acceptance criteria. AND List of Validation team members. Protocol shall contains:

PROSPECTIVE PROCESS VALIDATION REPORT : 

QUALITY ASSURANCE DEPT; API PROSPECTIVE PROCESS VALIDATION REPORT The validation report shall contains : All analytical supporting reports. Key raw material quality trend. Data analysis by utilizing effective statistical tools. Evaluation of Validation Data against acceptance criteria. Conclusion to be made based on Validation data analysis. Approval certification by appropriate management.

RETROSPECTIVE PROCESS VALIDATION : 

QUALITY ASSURANCE DEPT; API RETROSPECTIVE PROCESS VALIDATION Steps involved in Retrospective process validation: Gather the numerical values from the completed batch records and include assay values end-product test results and in-process data. Include data from at least the 20-30 manufactured batches. Trim the data by eliminating test results from non critical processing steps and delete all gratuitous numerical information. “The retrospective process validation is an established documented evidence that a process what it purports to do Based on review and analysis of Historical data.”

RETROSPECTIVE PROCESS VALIDATION PROTOCOL : 

QUALITY ASSURANCE DEPT; API Route of synthesis Detailed manufacturing procedures Equipment details Process profile Historical data review and analysis at least 20-30 consecutive batches Subject the resultant data to statistical analysis and evaluation Acceptance criteria defined Draw conclusions based on the analysis of the retrospective Validation data RETROSPECTIVE PROCESS VALIDATION PROTOCOL

CONCURRENT VALIDATION : 

QUALITY ASSURANCE DEPT; API CONCURRENT VALIDATION “Established documented evidence that a process does what it purports to do based on information generated during actual implementation of the process”. Protocol is same as Prospective process validation. Must provide rationale for justification of concurrent rather than prospective approach. Each batch is to be documented one-at-a-time prior to batch release. Provide all batch data and analysis of data obtained each time. Supplement with additional batch data as each new batch is generated. Requires approval by management prior to each batch release until validated status is achieved.

VALIDATION DOCUMENTATION : 

QUALITY ASSURANCE DEPT; API VALIDATION DOCUMENTATION The development of validation documentation is an essential part of any successful validation program. The documentation should be concise, unambiguous, detailed and thorough. Efficient change control tool is essential in keeping the documentation files current. The change control sop must define critical, major and minor changes so that the need for revalidation can be assessed Treat validation documentation as “Validation library” and it will provide reference to ongoing validation documentation.

REVALIDATION : 

QUALITY ASSURANCE DEPT; API REVALIDATION Revalidation is required : When? Change in critical component Change in critical peace of equipment Change in facility or location(site). Significant increase or decrease in batch size. Sequential batches that fail to meet product and process specifications.

BENEFITS OF VALIDATION : 

QUALITY ASSURANCE DEPT; API BENEFITS OF VALIDATION Improves Quality Assurance. Reduces Manufacturing cost. Enables more effective and rapid trouble shooting. Enables better system control and maintenance. Empowers all employees to control their processes and to improve them.

VALIDATION MASTER PLAN (VMP). : 

QUALITY ASSURANCE DEPT; API VALIDATION MASTER PLAN (VMP). A VMP describes clearly and concisely the company’s philosophy, expectations, and approach to be followed. The VMP identifies the systems and controls to be validated and the level of testing required. The VMP covers all aspects of the project such as equipment qualification, training, maintenance, and change control. Well developed and detailed VMP include: Provides a total picture of the project Is a management tool for tracking progress. Assignments to responsibility, which promote team work. Identifies acceptance criteria before the start of validation.

THANK YOU : 

QUALITY ASSURANCE DEPT; API THANK YOU

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