Presentad byManohar D Kengar

M.Pharm FY (ceutics)RCP KASEGAON

2017-18

Validation-process validation is “A

documented programme ,which provides

a high degree of assurance that a

specific process will consistently

produce, a product meeting its pre-

determined specification and quality

attributes”.

It reduces risk of regulatory non compliance. Reduction of time to the market for the new product. Reduces the chances of product re-cell for market. Eliminated the scrap & reduces the defect cost. The final release of the product batch would be

expedited. It requires less in-process control & end process

testing. Parametric release of batch can be achieved

validation.

Customer satisfaction

Customer mandated

Product liability

Control production cost

The development of the next

generation

safety

During the process the knowledge of process increases

Assures the repeatability of the process

Assures the fluency of production

Assures that the product is continuously according to the marketing authorization

Decreases the risk of the manufacturing problems

Decreases the expenses caused by the failures in production .Decreases the risk of failing in GMP

The major types of validation

Process validation

Cleaning validation

Equipment validation

Validation of analytical methods

Definition As per FDA nov.2008,The collection of

data from the process design stage

throughout production, which

establishes scientific evidence that

process is capable of consistently

delivering quality products.

stage 1.process design

stage 2.process qulification

stage 3.continuced process

verification

Prospective validation

Retrospective validation

Concurrent validation

Revalidation

Definition: A process of attaining and

documenting sufficient evidence to give

reasonable assurance, given the current

state of Science and Technology, that the

cleaning process under consideration

dose, and or will do, what is purpoes to

do.”

To minimize cross contamination.

To determine efficiency of cleaning process.

To troubleshooting in case problem identified

in the cleaning process and give suggestion to

improve the process.

Cross contamination product of one product in to another.

Product contamination by foreign material.

Microbial contamination.

Cleaning methods Manual cleaning method.

Semi automated procedures.

Fully automated procedures.

Product

Equipment.

Facilities.

Cleaning methods.

Cleaning agents.

Sampling.

Testing, Limits, and acceptance criteria.

Product

Equipment.

Facilities.

Cleaning methods.

Cleaning agents.

Sampling.

Testing, Limits, and acceptance criteria.

Definition As per FDA ,May 1987,Action of proving that

any equipment works correctly and leads to

the expected result is equipment

qualification.

It is not single step activity but instead result

from many discrete activities.

User requirement specification

Design qualification

Installation qualification

Operational qualification

Performance qualification

1)Before At documented 1) After 1)Whenever

Purchasing installation of installation instrument

a new new or 2)After major is used,

Instrument existing changes, e.g., dally

instruments repair, updates

Design qualification

Installation qualification

Operational qualification

Performance qualification

Definition:

The process by ,which its

established,by laboratory

studies,that the performance

characteristics of the method meet

the requirement for the intended

analytical application.

“The closeness of test result obtained by that

method to the true value.this accuracy should

be established application.”

Precision “The degree of agreement among individual

test result when the method is applied

repeatedly to multiple sampling of a

homogenous sample.”

The ability to assess unequivocally

analyte in the presence of components

that may be expected to be present,such

as impurities degradation product

matrix componenet.”

“A characteristic quantitative assays for low

levels of compound in sample matrices such

as impurities in bulk substances and

degradation product in finished

pharmaceuticals. It is the lowest amount of

analyte in a sample that can be determined

with acceptable precision and accuracy under

the stated experimental conditions.”