SOP on Validation Master Plan

SOP on Validation Master Plan


1.0 Purpose: This SOP describes the basic needs of Validation programme. 

2.0 Scope: This SOP applies to Quality Assurance Staff.

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure: Validation is defined as a documented program which provides a high degree of assurance that a planned process / procedure will consistently perform according to the intended specified outcomes. Validation studies are performed for analytical tests, equipment, facility systems and for processes. The master validation plan pertains to the whole facility that describes which equipment, systems, methods and processes will be validated and when they will be validated. The document provides the format required for each particular validation document, and indicates what information is to be contained within each document. The master validation plan also indicates why and when revalidations will be performed, either after changes or relocation of equipment or systems; changes to process or equipment used for processing; or for changes in assay methods or in equipment used in tests.

The master validation plan also indicates how to deal with any deviation and the time interval permitted between each validation.

Equipment & Systems Validation: A sequence of steps is involved in the validation of a equipment or system. Traditionally these steps are identified as design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
1. Design qualification (DQ): Design qualification is necessary when planning and choosing a new equipment or systems to ensure that components selected will have adequate capacity to function for the intended purpose, and will adequately serve the operations or functions of another piece of equipment or operation.

2. Installation qualification (IQ): Installation qualification ascertains that all of the unit components are installed as per specifications and according to the design drawings. It provides a construction verification in that the established specifications have been complied with. This also involves instrument connections. The IQ ensures the suitability of the completed system.

3. Operational qualification: operational qualification verifies the capability of the equipment to perform satisfactorily within operational limits. The goal of the OQ is to evaluate the limits of control within which the validated system is expected to perform and obtain information to evaluate changes to operation. Alarm conditions for utilities such as low steam pressure or instrument air; differential pressure limits; high or low, are a few examples of events that should be confirmed as functioning correctly.
4. Performance qualification: the purpose of the PQ is to provide rigorous testing to demonstrate the effectiveness and reproducibility of the total integrated process. This results in a documentation of the systems consistent performance as designed and operated. All the acceptance criteria are to be met under the worst-case process conditions. Failures should be identified and corrected and tests should be rerun to confirm the elimination of their causes.

After the intensive monitoring phase has been successfully completed, the system should undergo a long term evaluation, for perhaps a year or more. It is considered qualified or validated, based upon the data from the first monitoring phase, but due to time dependent effects, including the variables, long term evaluation is appropriate before a system is considered validated.

Process validation: A process is a series of interrelated  functions and activities using a variety  of specified actions and equipment which is designed to produce a defined result. To validate the reproducibility and consistency of a process, the full defined process is carried out using validated equipment.

Types of process Validation: Depending on when it is performed in relation to production, validation can be prospective, concurrent and retrospective.
1. Prospective Validation: It is normally applied to all processes and it must be performed before the firm introduces an entirely new product or when there is a change in the manufacturing process that may affect the product’s characteristics.
2. Retrospective Validation: It is normally applied to the systems or processes which are functioning well and consistently producing good products, already in distribution but such systems or processes have not previously been validated. Such type validation may be achieved by the review of historical manufacturing and testing data.
3. Concurrent Validation: May be appropriate for drug products that are produced frequently, only a limited number of batches have been produced, or when batches are produced by a validated process that has been modified. Concurrent validation may also be appropriated where the processes have been satisfactory and may have been retrospectively validated, but without documentation.

Revalidation:  Revalidation is needed to ensure that changes in the process and or in the process environment, whether intentional or intentional, do not adversely affect process characteristics and product quality.

Analytical Methods:  The principal purpose of analytical validation is to ensure that a selected analytical procedure will give reproducible and reliable results that are adequate for the intended purpose. It is thus necessary to define properly both the conditions in which the procedure is to be used and the purpose for which it is intended. Validation of analytical assays is the process of establishing one or more of; accuracy, precision, linearity, range, limit of detection, limits of quantitation, specificity and ruggedness as appropriate to the type of assay. 

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