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PROCESS VALIDATION
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2018-11-26 | 조회수 | 3,235 |
| 원문 | 한국보건산업진흥원 | ||
| 출처 | |||
PROCESS VALIDATION
INTRODUCTION
Quality cannot be adequately assured by in-process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications. Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Validation of the individual steps of the processes is called the process validation. Process Validation is one of the important steps in achieving and maintaining the quality of final product.
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. Process validation is a requirement of current Good Manufacturing Practices (cGMP) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices.
TYPES OF PROCESS VALIDATION
Depending on when it is performed in relation to production, validation can be prospective, concurrent, retrospective or revalidation.
1)ProspectiveValidation
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.
Wherepossiblecriticalsituationsareidentified,theriskisevaluated,thepotentialcausesareinvestigatedandassessedforprobabilityandextent,thetrialplansaredrawnup,andtheprioritiesset.Thetrialsarethenperformedandevaluated,andanoverallassessmentismade.If,attheend,theresultsareacceptable,theprocessissatisfactory.Unsatisfactoryprocessesmustbemodifiedandimproveduntilavalidationexerciseprovesthemtobesatisfactory.Thisformofvalidationisessentialinordertolimittheriskoferrorsoccurringontheproductionscale.
2) Concurrent Validation
Carried out during normal production. 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.
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.
3) 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 that the process is doing what it is believed to do. 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.
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. Retrospective validation may then be useful in establishing the priorities for the validation program. 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.
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.
4) 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:
•Revalidationafteranychangehavingabearingonproductquality.
•Periodic Revalidation carried out at scheduled intervals.
Revalidation after Change: Revalidation must be performed on introduction of any changes affecting a manufacturing and/or standard procedure having a bearing on the established product performance characteristics. Revalidation after changes may be based on the performance of the same tests and activities as those used during the original validation, including tests on sub processes and on the equipment concerned. Some typical changes which require revalidation include (but not limited to) the following:
-Change of product manufacturing raw or packaging materials.
-The transfer of a product from one plant to another.
-Changes to the product, the plant, the manufacturing process, or other changes that could affect product quality.
-Significant (usually order of magnitude) increase or decrease in batch size.
-Sequential batches that fail to meet product and process specifications.
Periodic Revalidation: It is well known that process changes may occur gradually even if experienced operators work correctly according to established methods. Similarly, equipment wear may also cause gradual changes. Consequently, revalidation at scheduled times is advisable even if no changes have been deliberately made.
Thedecisiontointroduceperiodicrevalidationshouldbebasedessentiallyonareviewofhistoricaldata,i.e.datageneratedduringin-processandfinishedproducttestingafterthelatestvalidation,aimedatverifyingthattheprocessisundercontrol.
PREREQUISITES FOR PROCESS VALIDATION
Before process validation can be started, manufacturing equipment and control instruments, as well as the formulation, must be qualified. The formulation of a pharmaceutical product should be studied in detail and qualified at the development stage, i.e. before the application for the marketing authorization is submitted. This involves pre formulation studies, studies on the compatibility of active ingredients and excipients, and of final drug product and packaging material, stability studies, etc.
Otheraspectsofmanufacturemustbevalidated,includingcriticalservices(water,air,nitrogen,powersupply,etc.),andsupportingoperations,suchasequipmentcleaningandsanitationofpremises.Propertrainingandmotivationofpersonnelareprerequisitestosuccessfulvalidation.
CONCLUSION
Validation has been proven assurance for the process efficiency and sturdiness and it is the full-fledged quality attributing tool for the pharmaceutical industries. Validation is the commonest word in the areas of drug development, manufacturing and specification of finished products. It also renders reduction in the cost linked with process monitoring, sampling and testing. Apart from all the consistency and reliability of a validated process to produce a quality product is the very important for an industry. Finally it can be concluded that process validation is a key element in the quality assurance of pharmaceutical product as the end product testing is not sufficient to assure the quality of finished product.
MAHMOUD AL QAWASMEH
Executive Consultant / GMP & RA – MENA Region
KHIDI
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