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INTRODUCTION TO PHARAMACEUTICAL VALIDATION Guided By:- Presented By:- Miss. Sapna Rathod Pratik Patel Quality Assurance M.Pharm Sem :- III Roll No. :- 01 1


CONTENTS:- Definition Scope of validation Advantage of Validation Validation master plan Qualification Installation qualification (IQ) Operational qualification (OQ) Personal qualification (PQ) Component qualification (CQ) Parameter of validation Types of validation Prospective validation Retrospective validation Concurrent validation Revalidation Conclusion References 2

Definition:- :

Definition:- Food and Drug Administration (FDA) defination :- validation refers to establishing documented evidence that a process or system when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. ISO definition : Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. 3

Scope of validation:- :

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 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. 4

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Validation done in a structured way according to documentation including procedures and protocols . 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 5

Advantages of validation:- :

Advantages of validation:- During the process the knowledge of process increases Assures the repeatability of the process Assures the fluency of production Assures that the product is continuously according to the marketing authorisation Decreases the risk of the manufacturing problems Decreases the expenses caused by the failures in production Decreases the risks of failing in GMP Decreases the expenses of the every day production even though the validation itself will create expenses 6

Organization for Validation:- :

Organization for Validation:- The qualification and validation work can be organized by employing one or more of the following structures : The consultant The task force The dedicated group. 1. The consultant:- The persons with consultants may not be permanent employees, they may be on contractual basis. There is a risk of incomplete job and extra expenses, if the validation job is not completed by the consultants within the bounds of time and cost. 7

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2. The task force :- The task force concepts refers to organisation structure with in the company in which persons proficient in different fields are drawn from different departments The departments are production, engineering , quality assurance, research and developments . 3. The dedicated group :- In the dedicated group members from the following departments are selected : Production Engineering Calibration laboratory Quality control laboratory Maintenance HVAC Product development 8

Validation Master Plan:- :

Validation Master Plan:- Definition:- A Validation Master Plan is a document that summarises the firm's overall philosophy, intentions and approach to be used for establishing performance adequacy . Benefits of VMP:- It provides the total pictures of the project. It is a management tool for tracking progress . Assignment of responsibility , which promote team work. It identifies acceptance criteria before the start of validation. 9

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Below is Universally accepted model popularly known as V model The left arm of the V always deals with defining the requirement and detailing the change and the right arm of the V ensure that for each item in the left arm. 10

Types of Process Validation:- :

Types of Process Validation:- Experimental approach Prospective validation Concurrent validation Analysis of historical data Retrospective validation Revalidation Periodic revalidation Revalidation after change 11

Prospective validation:- :

Prospective validation:- carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps. These are then evaluated on the basis of past experience to determine whether they might lead to critical situations. Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. The trials are then performed and evaluated, and an overall assessment is made . 12

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If, at the end, the results are acceptable, the process is satisfactory. Unsatisfactory processes must be modified and improved until a validation exercise proves them to be satisfactory. This form of validation is essential in order to limit the risk of errors occurring on the production scale , e.g. in the preparation of injectable products. 13

Concurrent validation:- :

Concurrent validation:- carried out during normal production. This method is effective only if the development stage has resulted in a proper understanding of the fundamentals of the process The first three production-scale batches must be monitored as comprehensively as possible. The nature and specifications of subsequent in-process and final tests are based on the evaluation of the results of such monitoring. This careful monitoring of the first three production batches is sometimes regarded as prospective validation. Concurrent validation together with a trend analysis including stability should be carried out to an appropriate extent throughout the life of the product. 14

Retrospective Validation:- :

Retrospective Validation:- Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged such experience and the results of in-process and final control tests are then evaluated. Recorded difficulties and failures in production are analyzed to determine the limits of process parameters. Retrospective validation is obviously not a quality assurance measure in itself, and should never be applied to new processes or products . It may be considered in special circumstances only, e.g. when validation requirements are first introduced in a company. 15

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Retrospective validation may then be useful in establishing the priorities for the validation programme . If the results of a retrospective validation are positive, this indicates that the process is not in need of immediate attention and may be validated in accordance with the normal schedule. For tablets which have been compressed under individual pressure-sensitive cells, and with qualified equipment, retrospective validation is the most comprehensive test of the overall manufacturing process of this dosage form. On the other hand, it should not be applied in the manufacture of sterile products. 16

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Some of the essential elements for Retrospective Validation are: Batches manufactured for a defined period (minimum of 10 last consecutive batches). Number of lots released per year. Batch size/strength/manufacturer/year/period. Master manufacturing/packaging documents. Current specifications for active materials/finished products. List of process deviations, corrective actions and changes to manufacturing documents. Data for stability testing for several batches. Trend analyses including those for quality related complaints. 17

Revalidation:- :

Revalidation:- Revalidation is needed to ensure that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality. Revalidation may be divided into two broad categories: Revalidation after any change having a bearing on product quality. Periodic revalidation carried out at scheduled intervals . Re-validation becomes necessary in certain situations. The following are examples of some of the planned or unplanned changes that may require re-validation: Changes in raw materials (physical properties such as density, viscosity, particle size distribution, and moisture, etc. , that may affect the process or product). 18

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Changes in the source of active raw material manufacturer. Changes in packaging material (primary container/closure system). Changes in the process (e.g., mixing time, drying temperatures and batch size) Changes in the equipmen t (e.g. addition of automatic detection system). Changes of equipment which involve the replacement of equipment on a “like for like” basis would not normally require a re-validation except that this new equipment must be qualified. Changes in the plant/facility. 19

Qualification:- :

Qualification:- Qualification should be completed before process validation is performed A logical, systematic process followed Start from the design phase of the premises, equipment, utilities and equipment Major equipment and critical utilities and systems normally require IQ, OQ and PQ Some equipment, utilities and systems require only IQ and OQ as the correct operation could be considered to be a sufficient indicator of its performance The equipment, utility and system should then be maintained, monitored and calibrated according to a regular schedule 20

Qualification Vs Validation:- :

Qualification Vs Validation:- Qualification and validation are essentially components of the same concept. The term qualification is normally used for equipment, utilities and systems . The term validation is normally used for processes. In this sense, qualification is part of validation. 21

Qualification stages:- :

Qualification stages:- There are four stages of qualification: design qualification (DQ); installation qualification (IQ); operational qualification (OQ); and performance qualification (PQ). All SOPs for operation, maintenance and calibration should be prepared during qualification Training provided and records maintained. 22

Design Qualification (DQ):- :

Design Qualification (DQ):- provide the document evidence that the functional and operational specification of the instrument, program, or equipment and details the rationale for choosing the supplier. 23

Installation Qualification (IQ):- :

Installation Qualification (IQ):- provide the document evidence that the process or equipment meets all specifications, is installed correctly , and all required components and documentation needed for continued operation are installed and in place. During IQ: Purchase specifications, drawings, manuals, spare parts lists and vendor details should be verified. Control and measuring devices should be calibrated. 24

Operational qualification:- :

Operational qualification :- Provides documented evidence that utilities, systems or equipment and all its components operate in accordance with operational specifications. Demonstrate satisfactory operation over the normal operating range as well as at the limits of its operating conditions (including worst case conditions) Operation controls, alarms, switches, displays and other operational components should be tested. 25

Performance qualification:- :

Performance qualification :- Provides documented evidence that utilities, systems or equipment and all its components can consistently perform in accordance with the specifications under routine use. Test results collected over a suitable period of time to prove consistency. 26

Requalification:- :

Requalification:- In accordance with a defined schedule. Frequency to be determined (e.g. on the basis of factors such as the analysis of results relating to calibration, verification and maintenance). Periodic and after changes e.g. changes to utilities, systems, equipment; maintenance work; and movement. 27


REFERENCES:- Carleton & Agalloco ,” Validation of Aseptic Processes” , 2 nd Edition, 1-16. Loftus. B.T, Nash. R.A, “Pharmaceutical processes validation”, 3 rd edition, volume 129, 17-20,47-50,71-73. Syed Imtiaz Haider , “Pharmaceutical Master Validation Plan”, 1 st Indian Reprint, 9-21. 28

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