Validation, Calibration, Qualification.pptx

Introduction of Validation and Calibration. Definition of Validation and Calibration. Qualification and Validation. Scope and importance
Difference between Calibration and Validation

1. Mahatma   Gandhi   Vidyamandir’s   Pharmacy college Panchavati ,Nashik Pharmaceutical Quality Assurance Department Sub : Pharmaceutical Validation Prepared By Guided by Mr. Kunal Anil Suryawanshi Mrs. H.R. Patil Mam Roll No:45 Presentation on Validation, Calibration its Scope, Importance and Advantages 1

2. 2 VISION- To be a Centre of professional excellence by contributing honestly to the pharmacist moulding process’ MISSION- Impart high quality education to graduates Contribute to all spheres of professional activities Uphold human values and ethics Nature them into globally competent professional

3. Content 3 Introduction of Validation and Calibration Definition of Validation and Calibration Qualification and Validation Scope a nd importance Difference between Calibration and Validation Advantages.

4. Introduction Concept of Validation was first coined by two officials 4 Later on it is an integral part of cGMP. Validation is an important element of QA.

5. Introduction Calibration is the process of determining accuracy. 5 Qualification Validation This is important for justifying the processes of With the calibration, the measurement are compared with an accepted reference measurement, to assure the considered measurement comply with the requirement.

6. Definition Validation: 6 Validation is the documented act of proving that any procedures, process, equipment, material, system actually leads to the expected results. According to USFDA: To establish documented evidence which provides a high 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 specified intended use are fulfilled  

7. Definition Calibration: 7 Calibration is the activity of checking, by comparison with a standard, the accuracy of a measuring instrument of any type. It may also include adjustment of the instrument to bring it into alignment with the standard. Calibration of an instrument also involves adjusting its precision and accuracy so that its reading come in accordance with the established standards. This is important for justifying the processes of qualification and validation. The instrument or equipment with the known accuracy is also known as standards. All the other instruments are measured against this standard. Calibration achieves 2 main objectives: (a) It checks the accuracy of an instrument. (b) It determines the traceability of the measurement.

8. Qualification 8 Qualification is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results.  Qualification : Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.   It is the entire process by which products are obtained from manufacturers or distributors, examined and tested, and then identified as a qualified products list. Qualification of instruments has been grouped into 4 phases as follows: Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance qualification (PQ)

9. Qualification 9 Design Qualification is the documented verification that the proposed design of the facilities, system, and equipment is suitable for the intended purpose. Design Qualification ( DQ) When to Perform DQ:   DQ should be performed— When new equipment is being purchased, and Existing equipment is being used for a new process. Installation qualification (IQ): Installation qualification is documented evidence that the premises, supporting utility, the equipment have been built and installed in compliance with  design specification and It verifies that the equipment has been installed as per the manufacturer’s recommendation 

10. Qualification 10 Installation qualification (IQ): When to Perform IQ:   It must be applied to new or changed facilities, systems, and instrumentality.  Operational Qualification (OQ):  Operational Qualification is the process of demonstrating that an instrument will function according to its operational specifications which results in a product of predetermined requirements. Performance Qualification (PQ):  It refers to established evidence that the process under anticipated conditions, consistently produces a product that meets all predetermined requirements. following successive Qualifications that must be completed as PQ.

11. Types and scope of Validation 11 There are four types of validations: Prospective Validation Retrospective Validation Concurrent Validation Revalidation Scope of Validation: Pharmaceutical manufacturers have to make sure their validation program covers all the important areas of pharmaceutical processing. The major areas include: Equipment validation (also called qualification). Facilities and utility validation (water system, air handling unit, compressed gas system, computer systems).

12. scope of Validation 12 Process validation. Cleaning validation. Analytical method validation and Instrument calibration. Validation needs to be carried out for any new equipment, premises, utilities, systems, procedures, processes.  It must also be performed when any major change has occurred in any of these. Validation is different from in-process tests the latter only helps in monitoring that a process runs as expected, whereas validation aims at demonstrating that a given process is suitable for routine use because it consistently yields a product of desired quality.

13. Importance of validation 13 Improve the use of technology Improve the business benefits Improve operational efficiency Improve the compliance with regulation Reduce the risk of failure Process optimization Reduce the cost Increased customer satisfaction

14. Difference between Calibration and Validation 14 Features Calibration Validation Definition Calibration is a process or action that compares the measurement values of a measuring device or equipment against a reference standard and certifies the measurement accuracy. Validation is a detailed documented process of confirming that the equipment or machine is installed correctly, operating effectively, and performing without any error. Simple meaning It is system performance checking. It is a performance analysis methodology.

15. Difference between Calibration and Validation 15 Uses To confirm that the equipment or measuring device is performing accurately. To confirm that the analytical method is performing accurately. Reference Standard It is done by comparing with a reference standard There are no known standard or reference standards used.  Procedure Executed according to calibration SOP. Executed according to the validation protocol. Objectives To nullify or remove the deviation by comparing with a reference or know standard. To verify the consistency of predictable results of the method, process, or procedure. Features Calibration Validation

16. Advantages 16 Optimized processes. Reduced cost of maintaining quality. Reduced complaints, rejections, batch failure, mix-ups, and cross-contamination. Better compliance with regulatory requirements. Assured quality of products. Validation: Calibration: Calibration fulfills the requirements of traceability to national/ international standards like ISO 9000, ISO 14000, etc. Calibration is proof that the instrument is working.

17. Advantages 17 Calibration: Confidence in using the instruments. Traceability to national measurement standards. Reduced rejections, failure rate thus higher return. Improved product and service quality leading to satisfied customers.

18. Reference https://www.linkedin.com/pulse/importance-qualification-validation-pharmaceutical-life-lakshan Chaitanya Kumar G, Rout RP, Ramtake S, Bhattacharya S. Process Validation, The Indian Pharmacist, 2005, 14-19. Potdar MA; Pharmaceutical Quality Assurance. 2nd Edition, Nirali Prakashan , 2009: 8.6-8.20. ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities), May 2011EMA/CHMP/ICH/ 425213/2011 ICH/ Committee for medicinal products for human use (CHMP), pg. no- 13. 18

19. THANK YOU! 19