Download - 1. validation
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“ 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”.
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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
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Raw material & packaging material Equipments Manufacturing operation Facilities Product design Cleaning Operator
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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
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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
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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”.
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a) Prospective Validation.
b) Retrospective Validation.
c) Concurrent Validation.
d) Revalidation
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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.
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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.
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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.
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Whenever there is a change in
formulation ,equipment or process which could
have impact on product effectiveness or product
characteristics.
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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.
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Prior to install a machine or equipment it is performed.
It include The size or volume of the machine. How it would be.
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Introduction & objective.
Identification of information.
Purpose of facility or equipment.
Construction details.
Details services required & provides.
Acceptance level.
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The OQ process ensure that the specific
modules of the system are operating
according to the defined specification for
accuracy, linearity & precision.
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It include:- Identification, objective & identification
information. Visual inspection. Functioning of switches & indicator lights. Check & calibration of sensor, airflow rate &
pressure etc. Cleaning procedure.
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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.
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Objective is to minimize the cross contamination.
Three sampling methods are generally used.
(i) Solvent rinse.(ii)Swab technique.(iii)Placebo rinse method
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This is related to individual quality & health condition
o Grouping Validation.o Medical Examination.o Personnel concerned are trained.
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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.
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Specificity Accuracy Repeatability Reproducibility Detection Limit Quantification Limit Sensitivity Range