Process Validation in Pharmaceutical Manufacturing

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process validation as 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 as a requirement of

current good manufacturing practices see

GMP for finished pharmaceuticals 21 CFR

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 process

validation involves a series of

activities taking place over the life

cycle of the product and process the US

Food and Drug Administration FDA has

proposed guidelines with the following

definition for process validation

process validation as establishing

documented evidence which provides a

high degree of assurance that a specific

process consistently produces a product

meeting its predetermined specifications

and quality attributes the process

validation activities can be described

in three stages

stage 1 process design the commercial

process as defined during this stage

based on knowledge gained through

development and scale-up activities

stage 2 process qualification during

this stage the process design as

confirmed as being capable of

reproducible commercial manufacturing

stage 3 continued process verification

ongoing assurance is gained during

routine production that the process

remains in a state of control types of

process validation the guidelines on

general principles of process validation

mentioned four types of validation a

prospective validation or pre market

validation be retrospective validation

see concurrent validation d-r-e

validation a prospective validation

establishing documented evidence prior

to process implementation that a system

does what it proposed to do based on

pre-planned protocols this approach to

validation is normally undertaken

whenever the process for a new formula

or within a new facility must be


for routine pharmaceutical production

commences in fact validation of a

process by this approach often leads to

transfer of the manufacturing process

from the development function to

production be 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 the product operating

processes or equipment this approach has

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 see

concurrent validation 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 the revalidation revalidation

means repeating the original validation

effort or any part of it and includes

the investigative review of existing

performance data

this approach is essential to maintain

the validated status of the plant

equipment manufacturing processes and

computer systems possible reasons for

starting the revalidation process

include the transfer of a product from

one plant to another changes to the

product the plant the manufacturing

process the cleaning process or other

changes that could affect product

quality the necessity of periodic

checking of the validation results

significant usually order of magnitude

increase or decrease in batch size

sequential batches that fail to meet

product and process specifications the

scope of revalidation procedures depends


the extent of the changes in the effect

upon the product don't forget to

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