Validation• Validation: A systematic study which ensures that systems, facilities and processes

are working adequetly and precisely. Validation is an integral part of QA (QA = Product design + GMP + QC + Quality goal activities).

• Spectrum of validation

• Materials: new drug substances (materials specification)

• Equipment; must be validated before use. Equipment validation| Specification—installation—commissioning (is capable of functioning consistently within operation limit)--- available for routine production.

•   Process: (the entire manufacturing process and its control during a batch production)

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• Testing: testing methods for QC must be validated)

The act of testing for compliance with a standard.

Aim of Validated operation: To assure quality

and TQM .

Validation is mandatory by the regulatory bodies to prove safety, efficacy, purity and effectives of the

drug productsmedical device andbiologics

Calibration:

A calibration is a process that compares a known (the standard) against an unknown (the customer's device). During the calibration process, the offset between these two devices is quantified and the customer's device is adjusted back into tolerance (if possible). A true calibration usually contains both "as found" and "as left" data.

Validation:

A validation is a detailed process of confirming that the instrument is installed correctly, that it is operating effectively, and that it is performing without error. Because a validation must test all three of these operational parameters, it is broken into three different tests: the installation qualification (IQ), the operational qualification (OQ), and the performance qualification (PQ).

People: (Every process involved people, therefore training and motivation of people)  Formulation: (new formulation- product specification, PD, Manufact cond. Stability) Critical systems: (Validation team must examine all critical systems such as, power supply, air supply, steam supply, water supply)  Environment: All aspects of environmental factors. Because’it is critical for product quality. Final pack: Final pack should be validated through stability study program.

Advantages of validation: Minimize Rejection lossHelp timely corrective actionsAssure consistent production performanceEnsure achievements of Quality goalsReduce end product testingAllow parametric releaseSort out the major risk of product liability

Operational Aspects of Validation: Team Work; production, development, engineering and QA Approach: The results must be reviewed by a technically sound person Documentation: complete documentation of study details Management accountability: The management of the respective deprtment should become accountable for its correct implementation Revalidation: When there is a change in the existing process, materials, equipment is necessary for revalidation