PROCESS VALIDATION OF PHARMACEUTICAL

PRODUCTS

Presented by-

Diksha KumariAnurag ChandaAnindita Biswas

B.pharm ,4thyr,7th Semester

Guru Nanak Institute of Pharmaceutical Science and Technology

What is Process validation?Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

Objectives

More confidence in quality systemMore confidence in product qualityMore confidence in manufacturing

processIncrease in product outputMore rapid investigation

Basic Principles For ValidationEstablish that the process equipment has the capability of

operating within required parameters;

Demonstrate that controlling, monitoring, and/or measuring equipment and instrumentation are capable of operating within the parameters prescribed for the process equipment;

Perform replicate cycles representing the required operational range of the equipment to demonstrate that the processes have been operated within the prescribed parameters for the process and that the output or product consistently meets predetermined specifications for quality and function; and

Monitor during routine operation for requalify and recertify the equipment.

TYPES OF PROCESS VALIDATIONProspective Validation

Prospective validation is conducted before a new product is released for distribution or, where the revisions may affect the product's characteristic.

Retrospective ValidationRetrospective validation is the validation of a process based on accumulated historical production, testing, control, and other information for a product already in production and distribution. This type of validation makes use of historical data and information which may be found in batch records, production log books, lot records, control charts, test and inspection results, customer complaints or lack of complaints, field failure reports, service reports, and audit reports.

Concurrent validation is a subset of prospective validation and is conducted with the intention of ultimately distributing product manufactured during the validation study.

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.

Approach to Process ValidationProcess Validation activities in three stage

1. Process Design -The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.

2. Process Qualification - Process Design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

3. Continues Process Validation - Ongoing assurance is gained during routine production that the process remains in a state of control.

VALIDATION PROTOCOLValidation Protocol Should Contain Minimum Following Things-

Objectives, scope of coverage of the validation study. Type of validation: prospective, concurrent, retrospective, re-validation. Number and selection of batches to be on the validation study. A list of all equipment to be used; their normal and worst case

operating parameters. Requirements for calibration of all measuring devices. Critical process parameters and their respective tolerances. Description of the processing steps: copy of the master documents for

the product. Sampling points, stages of sampling, methods of sampling, sampling

plans. Statistical tools to be used in the analysis of data. Training requirements for the processing operators. Specifications for raw and packaging materials and test methods. Forms and charts to be used for documenting results. Format for presentation of results, documenting conclusions and for

approval of study results.

MASTER VALIDATION PLAN The format and content should include:

Introduction: validation policy, scope, location and schedule.

Organizational structure: personnel responsibilities. Plant/process/product description: rational for inclusions

or exclusions and extent of validation.Specific process considerations that are critical and those

requiring extra attention. List of products/ processes/ systems to be validated,

summarized in a matrix format, validation approach.Re-validation activities, actual status and future planning.Key acceptance criteria.Documentation format.Reference to the required SOP’s.Time plans of each validation project and sub-project.

THANK YOU

References-

•Pharmaceutical Process Validation: Second Edition, edited by Robert A. Nash,Alfred H. Wacter;399-436.•Industrial process validation on solid dosage form : a review; Singh Harsimranjit et al.IRJP 2012 3(4).•Industrial process validation of solid dosage form: an overview; Satyabrata Jena et al., Volume 4, Issue 2, September – October 2010.

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