EQUIPMENT VALIDATION.pptx

Pharmaceutical Equipment Validation

1. EQUIPMENT VALIDATION Presented by: Swati Swagatika Swain Regd no- RA212225401006 Department of Pharmaceutics M. Pharm 1 st yr SRM College of Pharmacy

2. OUTLINES Introduction Validation study phase Parts of equipment validation Aim of equipment validation Roles of FDA in equipment validation Dissolution apparatus validation References 4/25/2022 2 Equipment Validation Swati Swagatika (RA2122254010006)

3. VALIDATION Definition : Validation is the documented act of proving that any procedure, process, equipment, material, activity or system showing the correct result or not. Objective of validation : It reduces the risk of regulatory non-compliance. Reduction of time to the market for the new products. It will increase productivity in lower cost. Reduces the chances of product re- call from market. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 3

4. TYPES OF VALIDATION 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 4

5. INTRODUCTION It is a regulatory requirement for pharmaceutical companies to perform instrument validation on all new equipment. Equipment validation requires detailed knowledge of the instrumentation system being validated and is therefore performed by company supplying the equipment. It gives the assurance that the equipment works properly and giving accurate result. 4/25/2022 5 Equipment Validation Swati Swagatika (RA2122254010006)

6. VALIDATION STUDY PHASE 4/25/2022 6 Equipment Validation Swati Swagatika (RA2122254010006)

7. PARTS OF EQUIPMENT VALIDATION 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 7

8. Principle of Equipment Validation 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 8 Equipment Must be To perform the operations which are to be carried out.

9. Aim of Equipment Layout and Design 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 9 To minimize the risk of errors To permit effective cleaning and maintenance To avoid Cross contamination and dirt, dust build up To avoid any adverse effect on quality of products

10. Design qualification It provides documented verification that the design of new instrument or equipment will result in a system that is suitable for the intended purpose. 4/25/2022 10 Equipment Validation Swati Swagatika (RA2122254010006)

11. INSTALLATION QUALIFICATION It tells whether the equipment is properly installed and whether it is suitable for that environment. 4/25/2022 11 Equipment Validation Swati Swagatika (RA2122254010006) Support Group Equipment Management Group Plant Engineering Group

12. Documented Records for Installation 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 12 Installation Qualification report includes The Supplier and the manufacturer System or Equipment Name Model and Serial Number Date of Installation

13. Contd... Installation Qualification Includes: 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 13 Inspection Checklist Installation Checklist

14. Inspection Checklist Instructions Explains how this section is physically executed Table of Contents Lists the major components of an equipment Specification Explains manufacturers specifications Actual Things that are actually observed are listed here 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 14

15. Installation Checklist This section of protocol determines whether or not a piece of the equipment or system as a whole meets the manufacturer’s design specifications. It is recorded as “ Yes ” or “ No ”. If “ No ”s are then recorded as deviations or deficiencies. Environmental Requirements: Specifically considers humidity, temperature of a particular piece of the equipment. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 15

16. Operational Qualification It demonstrates that an instrument will function according to its operational qualification in the selected environment within the acceptance criteria. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 16 Start up of Equipment according to the manual Programmable Logic Controller (PLC) All Functions and features are Operational SOP, Maintenance and Calibration Report Generation and Data Analysis Procedure Computerized Process Implies that Must be developed Conclusion

17. Contd... 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 17 Application SOPs Utilization List Process Description Critical Parameters Test Function List Test Function Summary Test Instrument Details Test Instrument Calibration Contents

18. Contd... 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 18 List the necessary test instruments before starting the test the instrument is to be calibrated and maintained till the completion of the test. Alarm testing Operation Testing Test Equipment Test Procedure

19. Performance Qualification Performance Qualification : The final selection for equipment qualification protocols. A process of demonstrating that an instrument or piece of equipment consistently performs according to a specification for it routine use. The factors like Loads, Volumes, Capacity and Power related issues should not be problematic throughout the specified range. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 19

20. Documentation System 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 20 Working Documentation System Documentation of Inspection Documentation of Internal Audit Documentation For quick location of document In case of fault in production For reliability on documentation

21. Contd... 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 21 List any test instrument necessary and must be calibrated prior to use and till the process complete. This is the final phase of validation process. Test Equipment

22. Roles of FDA in Equipment Validation 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 22 Validation Process Regulated by CFR : Code of Federal Regulation (US Govt.) for food and drugs Guidelines and regulations set forth by the FDA Validation Rules as per 21 CFR Part 210 and 211

23. Testing Procedure Table of Contents List of standardised sections Unique testing procedure Approval Page Preapproval Selection Final approval Selection Description Statement of purpose Standard Operating Procedure Calibration 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 23

24. Examples of Equipment Validation 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 24 Validation of Autoclave Validation of Ethylene Oxide Sterilisation System Validation of Radiation Sterilisation Method Validation of Filters Validation of Dissolution Apparatus

25. Validation of Autoclave 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 25

26. Validation of Dissolution Apparatus 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 26

27. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 27 Validation Dissolution Test Apparatus Why???

28. Validation of Dissolution Test Apparatus To have a high degree of assurance dissolution apparatus should be consistent and accurate in its performance. Therefore validation of this equipment is required. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 28

29. Design Qualification of Dissolution Apparatus When developing dissolution method design qualification is built into apparatus selection of process. Dosage form delivery system will determine choice of equipment. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 29 Example: First choice for beaded product may be USP app 3... As it is designed to consign beads in a screened in cylinder.

30. Installation Qualification of Dissolution Apparatus Used to verify that instrument has assembled in the appropriate environment and its functioning according to predetermined set of limit. Example: Setting of fully automated dissolution testing apparatus requires proper plumbing hot water, source stable bench top. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 30

31. Operational Qualification of Dissolution Apparatus During this qualification, analyst or vendor assess that equipment works as specified and generates the documented data. Example: For dissolution water bath temperature, Shaft RPM. Speed would be operational parameters. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 31

32. Performance Qualification of Dissolution Apparatus This is conducted to ensure that the system is in normal, operating environment and performing designed set of tasks within the specification. Example: Centering , Wobble, Height of paddle or basket to shaft, speed, temperature. 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 32

33. Reference Pharmaceutical quality assurance by Manohar A. Potdar , Nirali Prakashan , CBS Publishers Equipment and its validation by Nash. http://pharmatech.com www.slideshare.net www.wikipedia.com 4/25/2022 Equipment Validation Swati Swagatika (RA2122254010006) 33

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