Introduction and scope of validation

Introduction and scope of validation

1. Presented by, Jahnabi Sarmah Dept. of pharmacy M . Pharm 1 st sem INTRODUCTION AND SCOPE OF VALIDATION 1 Guided by, Dr. Ananta Choudhuri Associate professor Dept. of pharmacy

2. Content: 2 Introduction Need for validation Types of validation: Prospective validation (or premarket validation) Retrospective validation Concurrent validation Revalidation Scope of validation Reference

3. iNTRODUCTION : The concept of validation was first proposed by two Food and Drug Administration  ( FDA) official s. Byers and Bud Loftus, in the mid 1979s in(USA )order to improve the quality of pharmaceuticals. It was proposed in direct response to several problems in the sterility of large volume  parenteral  market. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitization and purified water production . 3

4. iNTRODUCTION : Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results . 4

5. introduction: There are 3 key points to from this definition: The evidence must be documented. Valiodation applies to several aspects of manufacturing, including process development, materials, personal and equipment. It should demonstrate that the system does what is expoected of it. 5

6. Need for validation : Customer satisfaction Customer mandated. Product liability. Control production cost Development of new generation. Safety. 6

7. TYPES OF PROCESS VALIDATION: The guidelines on general principles of process validation mentions four types of validation : A)  Prospective validation (or premarket validation) B)  Retrospective validation C)  Concurrent validation D)  Revalidation 7

8. Prospective validation: This is performed for all new equipment, product and processes. It is a proactive approach of documenting of design, specification and performance before the system is operational. This is the most defendable type of validation. 8

9. Retrospective validation: Retrospective validation is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process. Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence. Therefore , this type of validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in the composition of product, operating processes, or equipment. This approach is rarely been used today because it’s very unlikely that any existing product hasn’t been subjected to the Prospective validation process. It is used only for the audit of a validated process. 9

10. Concurrent validation: Concurrent validation is used for establishing documented evidence that a facility and processes do what they purport to do, based on information generated during actual imputation of the process. This approach involves monitoring of critical processing steps and end product testing of current production, to show that the manufacturing process is in a state of control. 10

11. Revalidation: Revalidation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Possible reasons for starting the revalidation process include : The transfer of a product from one plant to another. Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality. 11

12. ReVALIDATION: T he necessity of periodic checking of the validation results. Significant (usually order of magnitude) increase or decrease in batch size. Sequential batches that fail to meet product and process specifications. The scope of revalidation procedures depends on the extent of the changes and the effect upon the product. 12

13. ScOPE OF VALIDATION : Validation requires an appropriate and sufficient infrastructure including:–organization, documentation, personnel and finances. Involvement of management and quality assurance personnel Personnel with appropriate qualifications and experience Extensive preparation and planning before validation is performed. A specific programme for validation activities in place. 13

14. ScOPE OF VALIDATION : Validation done in a structured way according to documentation including procedures and protocols . Validation should be performed:–for new premises, equipment, utilities and systems , and processes and procedures;–at periodic intervals; and–when major changes have been made . Validation in accordance with written protocols. 14

15. ScOPE OF VALIDATION : 15 A written report on the outcome to be produced . Validation over a period of time, e.g.–at least three consecutive batches (full production scale) to demonstrate consistency. Process , materials and equipment to prove consistent yield of a product of the required quality. Manufacturers to identify what validation work is needed Significant changes (facilities, equipment, processes) -should be validated • Risk assessment approach used to determine the scope and extent of validation needed.

16. Reference: 16 Fundamental of quality assurance techniques…by Ramesh S awant and Sandip Hapse, First edition Dec 2011, Career publications. Pharmaceutical Quality Assurance...by Manohar Potdar, Second edition Dec 2007,Nirali Prakashan. IJRPC 2011` An overview of pharmaceutical validation: quality assurance view point’ by Nandhakumar et al. IJPR Review Article’ An Overview of pharmaceutical Validation and Process Controls in Drug Development’ Elsie Jatto and Augustine O. Okhamafe.

17. Scope: 17