“ Validation can be defined as a procedure that demonstrates that a process under standard conditions is capable of consistently producing a product that meets the established product specification”.

“ Validation may be defined as a systematic study which helps to prove that the systems and process perform their job adequately & consistent by as specified”.

Pharmaceutical validation is a vast area of work & it practically covers every aspect of pharmaceutical processing activity.

However it will point out at least the following areas of for pharmaceutical validation.

Analytical Instrument callibration Process utility services

Raw material & packaging material Equipments Manufacturing operation Facilities Product design Cleaning Operator

Enable scientist to communicates scientifically & effectively on technical matter.

Cost saving, reducing testing , & elimination of product retesting.

Useful for comparison of results compliance to cGMP/GLP.

For addressing analytical problem to proper form. Assurance of Quality Safety

Depending on time when it is performed relative to production it can be classified as:-

1. PROCESS VALIDATION 2. EQUIPMENT VALIDATION3. CLEANING VALIDATION4. PERSONNEL VALIDATION5. ANALYTICAL VALIDATION

The USFDA in guidelines on validation has offered this definition:-

“Process validation is established documented evidence which provides a high degree of assurance that specific process will constantly produce a product meeting its predetermined specification & quality characteristics”.

a) Prospective Validation.

b) Retrospective Validation.

c) Concurrent Validation.

d) Revalidation

This is employed when historical data of the product

is not available or is not sufficient & in process &

furnished product testing are not adequate to ensure

reproducibility.

Such validation is conducted prior to release of

either new product or product made under revised /

new manufacturing process.

This provide trend of comparative results i.e. review

& evaluation of existing information for comparison

when historical data is sufficient & readily available.

This method is chosen when Prospective validation

can not be justified for economic consideration &

resource limitation.

Based on information generated during

implementation of a system.

For this extensive testing & monitoring are

performed as part of running of the method.

This validation verifies the quality characteristic

of a particular batch & provide assurance.

Whenever there is a change in

formulation ,equipment or process which could

have impact on product effectiveness or product

characteristics.

The validation of facilities equipment & services is called ‘ Qualification’ this is divided into:-

a) Design Qualification. b) Installation Qualification. c) Operational Qualification. d) Performance Qualification.

Prior to install a machine or equipment it is performed.

It include The size or volume of the machine. How it would be.

Introduction & objective.

Identification of information.

Purpose of facility or equipment.

Construction details.

Details services required & provides.

Acceptance level.

The OQ process ensure that the specific

modules of the system are operating

according to the defined specification for

accuracy, linearity & precision.

It include:- Identification, objective & identification

information. Visual inspection. Functioning of switches & indicator lights. Check & calibration of sensor, airflow rate &

pressure etc. Cleaning procedure.

PQ testing is conducted under actual running condition across the whole working range.

Once IQ & OQ have been executed & and have been approved then the PC can be performed.

It include various performance parameter of any instrument.

Objective is to minimize the cross contamination.

Three sampling methods are generally used.

(i) Solvent rinse.(ii)Swab technique.(iii)Placebo rinse method

This is related to individual quality & health condition

o Grouping Validation.o Medical Examination.o Personnel concerned are trained.

Refers to the evaluation & proving that an analytical method serves the intended purpose.

It can be classified into Three types Personnel ( analyst) Equipment & facilities Procedure (adopted for analyzing a

drug.

Specificity Accuracy Repeatability Reproducibility Detection Limit Quantification Limit Sensitivity Range