VALIDATION & VALIDATION MASTER PLAN 2

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VALIDATION & VALIDATION MASTER PLAN :

VALIDATION & VALIDATION MASTER PLAN GUIDED BY : Dr. K. SHANTA KUMARI (professor & H.O.D) SUBMITTED BY: T .VENKATA SIVA REDDY (Y18MPH0863) DEPARTMENT OF PHARAMCEUTICAL ANALYSIS NIRMALA COLLEGE OF PHARMACY

VALIDATION:

VALIDATION The objective of any pharmaceutical industry is to manufacture products of requisite attribute and quality consistently at lowest possible cost . Validation is a tool of quality assurance ,which proivde a high degree of assurance that is specific process will consistently produce a product,meeting its predetermind specification and quality characteristics . Validation include all active drug compounds whether bulk, intermediate or finished goods

TYPES OF VALIDATION:

TYPES OF VALIDATION PROSPECTIVE VALIDATION CONCURRENT VALIDATION RETROSPECTIVE VALIDATION REVALIDATION

PROSPECTIVE VALIDATION:

PROSPECTIVE VALIDATION Prospective validation is used during the product development stage It is conducted prior to the distribution of either a new product or a product made under a modifications production process. It is preplanned scientific approach and includes the initial stages of formulation development,setting of process sampling plans, designing of batch records, etc Validation of the process, at least first three commerical batches on commerical scales are then taken along with the production personnel and all specifications and parameters limits are finalized and product is then handed . Every aspect from LS to CS is documented on record of the prospective validation carried out.

CONCURRENT VALIDATION:

CONCURRENT VALIDATION The validation which is carried out during production . It is a process where current production batches are used to monitor processing parameters After three commerical batches are taken and the process is handled over to the manufacturing personnel , the verification of the process parameter still goes on . The process parameter are evaluated for the manufacturing facilities , batch after batch and studied if any deviation is observed or required this time in process quality control parameter are also monitored If initial development batches and the CP batches use same type of equipment then revalidation of the whole process during CM may not be required I.P.Q.C tests should be carried out for every batch to see that the process is moving forward in the expected direction

RETROSPECTIVE VALIDATION:

RETROSPECTIVE VALIDATION It is conducted for a product already being marketed and is based on extensive data accumulated over several lots and over time . This validation is defined as establishing documented evidence that a system does what purports to do based on a review and analysis of historical data and information obtained during production of clinical or marketable products. Usually statistical packages as well as manual reviews are used. Where existing data if not adequate , additional tests should be performed.

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some of the essential elements for retrospective validation: Batches manufactured for a definite period. No of lots released per year Batch size/strength/manufacturer/year/ period Master manufacturing /packaging documents Data for stability for several batches

REVALIDATION:

REVALIDATION This validation is required when there is a change in any of the critical process parameters, formulation, primary packing components ,raw material fabricator , major equipment or premises . Failure to meet product and product specification in batches would also require process validation. Some rules require under the following circumstances Changes in the raw materials Changes in the source of active raw material manufacturer Changes in packaging material Changes in the process

DOCUMENTATION FOR VALIDATION:

DOCUMENTATION FOR VALIDATION SOP’S SPECIFICATIONS VALIDATION MASTER PLAN QUALIFICATION PROTOCOLS & REPORTS VALIDATION PROTOCOLS & REPORTS

VALIDATION MASTER PLAN :

VALIDATION MASTER PLAN It is an internally approved document that describes in clear and concise wording about the expectations , intentions ,methods and approach to be used during the entire validation effort. It should not repeat information documented else where but should refer to existing documents such as policy documents ,Sop’s and validation protocols and reports. The size of validation master plan cannot be defined but it should not be just 4/5 pages, at the same time it cannot be 400/500pages. F.D.A .inspectors that the company has a highly organized approach to the validation programmer

MEMBERS OF VALIDATION MASTER PLAN :

MEMBERS OF VALIDATION MASTER PLAN Member Quality assurance dept Member from production Member Engineering Member from calibration lab Member from QC lab Member from maintenance Member from HVEC dept Member from product development lab

CONTENTS FOR A VALIDATION MASTER PLAN :

CONTENTS FOR A VALIDATION MASTER PLAN Approvals Publication record Responsibilities Introduction Scope Design Description Commissioning & Qualification

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Computer systems validation Cleaning validation Qualification matrix List of Required standard operating procedures Equipment &Utility system Descriptions Quality systems References

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APPROVALS: section contains the signatures and job titles of the people who author and approve the validation master plan PUBLICATION RECORDS : contains the revision history of the VMP . The VMP is meant to be a working document. RESPONSIBILITIES: who is responsible for what INTRODUCTION: specifies the company ,business unit and location SCOPE: The limits of the validation project and details which equipment is included in the project and which is not

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DESIGN DESCRIPTION : Briefly ,but systematically and new installation or process. particular mention should be made of how flow patterns of people , materials and equipment were taken into consideration . COMMISSIONING &QUALIFICATION: if a system has no significant impact on the quality of the product then you may decide that normal commissioning is sufficient . Documented should verified by GEP’S , ASME , NEMA . COMPUTER SYSTEM VALIDATION : provide the rationale for validating or not validating each computer system that affects the quality of the product. QUALIFICATION MATRIX : it is center piece of the VMP . It serves as a reference point for all of your validation activities. In this section you should list in tabular form all of the utility and process system associated with the project.

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The qualification matrix can be used to track the progress of the validation project once the VMP has been approved. SOP’S : this section is also composed in tabular form and can also serve as a tracking mechanism for the progress of the project. EQUIPMENT & UTILITY SYSTEM : the purpose and operational concept of each system . In addition you should think through at this time what qualification tests you will conduct and consider hoe you will determine acceptance criteria. QUALITY SYSTEM : once the new process is validated the FDA wants to know how you intend to keep it in a validated state until the last batch of product is produced. The VMP demonstrates how you intend to accomplish that by laying out the list of SOP’S that support the validated systems . Listed below are some of the procedures :

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Corrective and preventive action (CAPA) Preventive maintenance / calibration Training Change control Out of specification results(OOS) Deviations Failure Investigations Audits References

IMPORTANT AREAS OF VMP:

IMPORTANT AREAS OF VMP Introduction to the proposed validation programme. Validation of building and facilities Validation of equipment used in production and utilities Pharmaceutical process validation Water system HVAC system Cleaning validation Vendor certification Man power validation

ADVANTAGE OF VMP:

ADVANTAGE OF VMP What activities are to be performed Who is going to perform these activities When the activities should start and when they should get over time How the activities will be performed Document will be generated What is the policy on revalidation

GUDELINES ON PREPARING VMP:

GUDELINES ON PREPARING VMP Type your VMP on A4size paper with all side borders File in a presentable form Have sufficient explanatory drawings use colour drawings if possible Clearly divide the VMP in different sections like introduction , main body and appendices It must be dated and singed properly by authorized persons If found appropriate you may discuss this with the F.D.A people in advance

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Conclusively it can be said that a VMP should be a reflecting mirror of your good intentions in the area of your planned work on validation. It should be reviewed and revised at a definite time frequency preferably once in a year.

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THANK YOU

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