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Introduction to validation

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Introduction to validation

  1. 1. INTRODUCTION TO PHARMACEUTICAL VALIDATION, SCOPE & MERITS OF VALIDATION Presented By Sachinkumar B 1st Year M.Pharma Dept of Pharmaceutics Srinivas College Pharmacy,Mangalore 1
  2. 2. Contents 1) Introduction 2) Definitions 3) The field of validation 4) Reason for validation 5) Functions of different departments 6) Scope of validation 7) Merits of validation 8) Reference 2
  3. 3. Introduction The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, In 1979 in USA, to improve the quality of pharmaceuticals. And later on it became an important part of current good manufacturing practices.  Validation is an integral part of quality assurance; it involves the systemic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified.  Validation in itself does not improve processes but confirms that the process have been properly developed and are under control. 3
  4. 4. Definitions: • According to the US Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence which provides a higher degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” • According to ISO: “validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled.” 4
  5. 5. • According to European Commission: “Action providing in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually lead to the expected results”. 5
  6. 6. Validation should thus be considered in the following situations: • Totally new process; • New equipment; • Process and equipment which have been altered to suit changing priorities; and • Process where the end-product test is poor and an unreliable indicator of product quality. 6
  7. 7. The field of validation 1. Equipment validation 2. Facilities validation 3. HVAC System validation 4. Cleaning validation 5. Process validation 6. Analytical method validation 7. Computer system validation (CSV) 8. Packaging validation 9. Cold chain validation 7
  8. 8. Reason For Validation 1) It is regulated requirement stipulated in cGMP 2) Greater impart on product development process 3) Cost reduction 4) To produce zero defect product 5) End result of validation will be higher quality more uniform and reproducible product 6) Makes a good business source ,decrease batch reject & retails 8
  9. 9. Functions of different department Validation is a team effort. Validation Team QA QC R & DManufacturing ENGINEERING 9
  10. 10. Engineering Install, quality & certify plant facility, equipment and support system R & D Design, optimize, quality manufacturing process with limits & specifications Manufacturing Operate & maintain plant facilities, equipment support system process and strictly follow SOP QC Follow the validation protocol develop by QA & validate the incoming stock in process critical system & final product QA Establish approvable validation protocols & conduct process validation by monitoring, sampling, challenging the process and equipment 10
  11. 11. Classification of validation 1) Analytical validation 2) Process validation 3) Qualification validation 4) Cleaning validation 11
  12. 12. Scope of validation Validation requires an appropriate & sufficient infrastructure including: Organization, Documentation, Personnel and Finances Involvement of management and quality assurance personnel Personnel with appropriate qualifications and experience Extensive preparation & planning before validation is performed 12
  13. 13. Continue… Validation done in a structured way according to documentation including procedures and protocols Validation should be performed: For new premises, equipment, utilities system and processes and procedures At periodic intervals; and When major changes have been made. Validation is accordance with written protocols. Manufactures to identify what validation work is needed 13
  14. 14. Merits of validation  During the process the knowledge of process increases  Assures the repeatability of the process  Assures the fluency of production  Assures that the product is continuously according to the marketing authorization 14
  15. 15. Continue…  Decreases the risk of manufacturing problems  Decreases the expenses caused by the failure in production  Decreases the risk of failing in GMP  Decreases the expenses of the every day production even through the validation itself will create expenses 15
  16. 16. Reference  Industrial pharmacy, A Comprehensive approach, by D.K Tripathi,(671-699)  Pharmaceutical process validation: An Overview, by M.d Shoaib Alam etal ; Journal of advanced pharmacy education & research, Oct-Dec 2012, vol 2, issue 4, (190-196) 16
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