Validation.pptx

validation is an important documentation protocol used in most of the laboratories and industries which is used for validation and evaluating different research protocols and equipment used in product formulation and development

1. Pharmaceutical Validation Under the guidance of Asst. Prof. Mrs. Komala Presented By Rakesh. G (18P6422) B.Pharm, 4 th Year, 7 th Semester KR College of Pharmacy, Bangalore

2. Contents Introduction and History Departments responsible for validation, advantages and scope of validation. Validation and its types. Validation documentation Validation Master Plan Validation protocol Validation report Conclusion References

3. VALIDATION Definition: Validation is a part of quality assurance which provides documented evidence for any procedure, process, design, material, activity or system which leads to yield the desired quality of results as approved. As per FDA USFDA: Validation is establishing documented evidence which provides a high degree of assurance that a specific process, system, equipment or assay will consistently produce the desired results accordingly to predetermined specifications and quality attributes.

4. History of Validation The concept of validation was first proposed by two FDA officials, Ted Byers and Bud Loftus , in order to improve the quality of pharmaceuticals. In 1976 the FDA proposed a whole set of current GMP (cGMP) regulations which were revised several times. In several major countries GMP regulations are considered official law and noncompliance in prosecutable. USFDA was the pioneer in advocating the concept of process validation, but till 29 th September 1978 there was no definition and no cGMP regulations talked anything about validation.

5. Departments responsible for Validation Site Validation Committee: Develop site Master Validation Plan (MVP). Manufacturing Department: Prepares the batches as though their routine production batches and assist the collection of data. Quality Assurance: Approves protocols and reports. Checking the compliance of documentation and procedures. Review of validation documents. Quality Control: Perform testing contracts, validation testing, review protocols and reports. R&D: Deals with product design. Engineering Department: Installation, quality and certify plant, facilities, equipment and support systems

6. Advantages of Validation Process parameters and controls are determined during the validation of any process or system. It helps to determine the worst case and risks that may arise during the manufacturing of the quality products. Validation helps to investigate the deviations caused during the process. Deep study and understanding of the system and equipment are made possible due to validation. The risk of regulatory non-compliance is minimized after the validation. A validated process required less process control and the finished product testing. Batch to batch variation is minimized due to the validation of process, systems and equipment. Reduces the production cost of product Increases the production of manufacturing facility due to the minimized rework and rejection. A validated process required less process control and finished product testing. Decreases the chances of the failure of the batches.

7. Scope of Validation Appropriate and sufficient system of organizational and documentation infrastructure, sufficient personnel and financial resources to perform validation tasks in timely manner. Personnel with appropriate qualifications and experience should be responsible for performing validation. They should represent different departments depending on the validation work to be performed. There should be proper preparation and planning before validation performed. Validation should be performed: For new premises, equipment, utilities and systems, processes and procedures. At periodic intervals; and When major changes have been made. Validation should be performed in accordance with written protocols. A written report on the outcome of the validation should be produced.

8. Validation practically covers every aspect of pharmaceutical processing activities, hence defining the Scope of Validation becomes a really difficult task. However, a systematic look at the pharmaceutical operations will point out at least the following areas for pharmaceutical validation. Packaging materials Analytical Instrument Calibration Process Utility services Raw materials Equipment Facilities Manufacturing operations Product Design Cleaning

9. Validation and its types

10. Process Validation : It is defined as the collection and evaluation of data, from the process of design stage throughout production, which established scientific evidence that a process is capable of consistently delivering quality products. Cleaning Validation : Cleaning validation provides documented set up with a high degree of surety that particular system/equipment or part of ids consistently clean up to predetermined quality and acceptable limits.

11. Equipment Validation : Equipment validation is established documented set up that proves any equipment works correctly and leads to accepted and accurate results (predetermined results). The process of equipment validation is based on the principle that equipment must be designed, constructed, maintained and adapted to perform operations which are to be carried out. Analytical Method of Validation : The purpose of analytical validation is to verify that the selected analytical procedure will give reliable results that are adequate for the intended purpose. There are different parameters which come under this method are; Accuracy, Precision, Reproducibility, Specification, Range, Detection limit etc.

12. Validation Master Plan Validation Master Plan is an internally approved document that describes I clear and concise working about the general expectations, intensions, methods and approach to be used during the entire validation process. VMP should be a summary document and should be brief, concise and clear. Format and Content: Introduction: Validation policy, scope, location and schedule. Organizational structure: personnel responsibilities Plant/process/product description. Specific process considerations that are critical and require extra attention. List of products/processes/system to be validated, summarized. Re-validation activities, actual status. Key acceptance criteria Documentation criteria and reference of the SOP’s. Time plans of each validation project and subproject.

13. Validation Protocol It is defined as a written plan describing the process to be validated, including production equipment and how validation will be conducted. Objectives, scope of coverage of the validation study. Outline of Validation Protocol: Objective and scope Process description Identification of critical parameters Description of analytical method Documentation Conclusion and Approval Final Report

14. Validation Report A written report should be available after completion of the validation. If found acceptable, it should be approved and authorized. If found acceptable, it should be approved and authorized. The report should include at least the following: Title and objective of study Reference to protocol Details of material Equipment Programmes and cycles used Details of procedures and test methods Results Recommendations on the limit and criteria to be applied on future basis

15. Conclusion Pharmaceutical validation which incorporates assay validation, cleaning validation, equipment validation and additionally the general procedure of approval is vital in strength examination, clinical improvement, like example, bioavailability, bioequivalence.

16. References Jindal D, Kaur H, Patil RK, Patil HC. Validation – In pharmaceutical industry: Equipment validation: A brief review. Adesh Univ J Med Sci Res 2020;2(2):94-8. Saroj Kumar Raul, Gopal Krishna Padhy, Anjan Kumar Mahapatra, Soudamini Alekha Charan. An Overview of Concept of Pharmaceutical Validation. Research J. Pharm. and Tech. 7(9): Sept. 2014 Page 1081-1090. Sharma PP. Validation in Pharmaceutical Industry (6th ed). United Kingdom: Informa Healthcare Publication; 2016. p. 51-70. Haider SI. Pharmaceutical Master Validation Plan, The Ulimate Guide to FDA, GMP and GLP Complience, Indian Special Edition, Informa Healthcare, p311

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