validationqualification-200524131037.pptx

This is information regarding the validation activities.

1. VALIDATION AND QUALIFICATION 1

2. CONTENTS VALIDATION QUALIFICATION ADVANTAGES OF VALIDATION STREAMLINING OF VALIDATION & QUALIFICATION VALIDATION MASTER PLAN USER REQUIREMENT SPECIFICATION DESIGN QUALIFICATION FAT/SAT INSTALLATION QUALIFICATION OPERATIONAL QUALIFICATION PERFORMANCE QUALIFICATION 2

3. VALIDATION “ V alidation means conformation by examination and provision of objective evidence that a particular requirements for a specific intended use can be consistently fulfilled.” 3

4. QUALIFICATION “ Qualification is the documented evidence that a specific equipment, facility/system is fit / ready for intended use”. 4

5. Validation vs Qualification Validation Qualification is the documented evidence which provides a high degree of assurance that a specific process will consistently meet its predetermined specifications and quality attributes. Proves that the process is under control. It is a sub-set of validation and applies to equipment, instrument, facilities, software, control systems and utility systems that support or affect a GMP process. For validation to occur appropriate qualification must be successfully completed. 5

6. Need for validation Basic requirement for the product quality system. Assure every lot of each product meet all the quality requirements. It is capable of achieving the intended results. For taking appropriate actions in case of non-compliance. 6

7. Advantages of validation Conformation to GMP requirements. To identify root cause of problems. Makes process better understand. Reduces the risk of problems. Reduces defect cost. Assures smooth running of the process. Documents that process or activity is in control. Maintains a company’s public image. Documents that the final product has followed reliable manufacturing process. 7

8. Streamlining of qualification and validation Set of strategies, mostly risk and science based, to transform or standardize validation activities and documentation. Typically reduces resources such as time, personnel, and cost. The practice enhances reliability, cost, and quality of the product. 8

9. Validation Master Plan(VMP) It is a comprehensive document describing the applicable validation requirements for the facility, and providing a plan for meeting those requirements. Brief, concise and clear. Comprise : prospective validation : concurrent validation : Retrospective validation :Re-validation . 9

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11. Validation Report 11

12. User requirement specification URS defines the functions to be carried out, the data on which the system will operate, and the operating environment. Reduces the total system effort and cost. Provides the input to user acceptance test specifications. Serves as a reference. URS must be kept updated. 12

13. Capability : features or functions of the system needed or desired by the user. Condition : measurable quantitative attributes and characteristics that are stipulated for any capacity. Constraint : requirements that are imposed by circumstance , force or compulsion, eg : regulatory or corporate standards. 13

14. VALIDATION PROCESS TYPES: : Process validation. : Computer(process controller) validation. : Cleaning validation. : Analytical method validation . 14

15. Process validation Establishing documentary evidence that a process does what it purports to do. Qualification accomplished are : :Design qualification :Installation qualification :Operational qualification :Performance qualification. 15

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17. Steps for process validation Step 1: protocol. Step2:protocol approval. Step 3:validation exercise. Step4:validation package preparation. Step5:validation approval. Protocol is a document that gives details of critical parts of manufacturing process. 17

18. Process Validation CHANGE 18

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20. Design qualification(DQ) It is a documented collection of activities that defines the functional and operational specifications of the instrument/equipment , on the intended purpose of the equipment. Contains (1) description of equipment (2) References: (a)specification (b)quotation (c)order number (3)machine specifications (4)approvals/ authorisation (5)manuals (6)certifications 20

21. FAT Documented evidence that a piece of equipment or system has been adequately tested at the manufacturer’s facility and performed to the end user’s expectations prior to delivery to the end user. Executed during final part of design and engineering phase before final installation. Performed at manufacturers work shop. 21

22. SAT Site Acceptance Test. Documented evidence that a piece of equipment or system has not been affected in the transportation and has been adequately tested at the end user’s facility and performed to end user’s expectation 22

23. Installation qualification(IQ) “Documented verification which confirms that all key aspects of installation adhere to appropriate codes and approved design intentions and that the manufacturers recommendations are suitably considered”. Properly installed with no hazards. Information needed: :Identification information. :Utility requirements :Safety features :Supporting documents. Conducted using an approved protocol. 23

24. Operational qualification (OQ) Establishing confidence that process equipment and sub systems are capable of consistently operating within stated limits of tolerance. Process controls are qualified during OQ. SOPs for use, maintenance, calibration , cleaning of the plant, schedules for maintenance and calibration are developed. . 24

25. Performance qualification(PQ) Documented collection of activities necessary to demonstrate that an equipment/system consistently perform according to the specifications defined by the user, and is appropriate for the intended use. Qualify the entire plant with respect to the production process. All necessary SOPs should be approved. 25

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27. THANK YOU 27