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VALIDATION IN

PHARMACEUTICAL INDUSTRY

SISKA LENGGO PUTRI0811013124


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Validation is importantthings in the

pharmaceuticalindustry.


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Types of Validation

Prospective validation

Establishing documented evidence that a

piece of equipment/process or system will do

what it purports to do, based upon a pre-

planned series of scientific tests as defined in

the Validation Plan.


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Concurrent validation

Is employed when an existing process can be

shown to be in a state of control by applying

tests on samples at strategic points

throughout a process; and at the end of the

process.


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All data is collected concurrently with the

implementation of the process until sufficient

information is available to demonstrate

process reproducibility


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Retrospective validation

Establishing documented evidence that a

process does what it purports to do, based on

review and analysis of historical data.


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TYPE OF QUALIFICATION

DESIGN QUALIFICATION

INSTALLATION

OPERATIONAL PERFORMANCE


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Design Qualification (DQ)

The intent of the DQ is met during the design

and commissioning process by a number of

mechanisms, which include:


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Installation Qualification (IQ)

IQ provides documented evidence that the

equipment or system has been developed,

supplied and installed in accordance with

design drawings, the supplier's

recommendations and In-house requirements.


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Operational Qualification (OQ)

OQ provides documented evidence that the

equipment operates as intended throughout

the specified design, operational or approved

acceptance range of the equipment, as

applicable. In cases where process steps are

tested, a suitable placebo batch will be usedto demonstrate equipment functionality.


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All new equipment should be fully

commissioned prior to commencing OQ to

ensure that as a minimum the equipment is

safe to operate, all mechanical assembly and

pre-qualification checks have been completed,

that the equipment is fully functional and that

documentation is complete.


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Performance Qualification (PQ)

The purpose of PQ is to provide documented

evidence that the equipment can consistently

achieve and maintain its performance

specifications over a prolonged operating

period at a defined operating point to produce

a product of pre-determined quality.


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The PQ documentation should reference

standard manufacturing procedures and batch

records and describe the methodology of

sampling and testing to be used.


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Cleaning Validation (CV)

CV provides documented evidence that a

cleaning procedure is effective in reducing to

pre-defined maximum allowable limits, all

chemical and microbiological contamination

from an item of equipment or amanufacturing area following processing


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Method Validation (MV)

MV provides documented evidence that

internally developed test methods are

accurate, robust, effective, reproducible andrepeatable. The validation protocols should

reference background documentation relating

to the rationale for the determination of limitsof detection and method sensitivity.


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Computer Validation

Computer Validation provides documented

evidence to assure systems will consistentlyfunction according to their pre-determined

specifications and quality attributes,

throughout their lifecycle.


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Referance

BPOM. 2006. Pedoman CPOB. Jakarta: BPOM

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