re validation

8/4/2019 Re Validation

http://slidepdf.com/reader/full/re-validation 1/13

Facilitated by:

Dr. T. M. Pramodkumar

Professor

JSSCP, Mysore.

Prepared by:

Hardik Pandya

1st M.Pharm

Regulatory affairs

JSSCP, Mysore

1



Re-validation provides the evidence that

changes in a process and /or the process

environment that are introduced do not

adversely affect process characteristicsand product quality. Documentation

requirements will be the same as for the

initial validation of the process.

2



It would not be feasible to use the equipments withoutknowing whether it will produce the product we want or

not.

The pharmaceutical industry uses expensive materials,

sophisticated facilities & equipments and highly qualifiedpersonnel.

The efficient use of these resources is necessary for the

continued success of the industry. The cost of product

failures, rejects, reworks, and recalls, complaints are the

significant parts of the total production cost.

Detailed study and control of the manufacturing process-

re-validation is necessary if failure to be reduced and

productivity improved.

3



The pharmaceutical industries are concerned

about Re-validation because of the following

reasons.

Assurance of quality

Cost reduction

Government regulation

4



1) Revalidation after any change in the

product formula, process ,method which

affect the quality of product.2) Scheduled periodic Revalidation.

5



Following changes requires re-validation: Raw material, starting material:

Drug product and its process should be revalidated if there

are changes in the starting material, even if there are

change in the physical properties of the starting material

like crystal properties, viscosity, bulk density, specific

gravity, particle size distribution of the active as well as

excipients as these physical properties might adversely

affect the process and then product quality.

6



Packaging material:

If there are changes done in packaging materialrevalidation must be done if the packaging material comes

directly in contact with dosage form as well as if the

physical properties of the packaging material being

changed may affect the stability and quality of the drug.

Manufacturing process:

Re validation must be done whenever there are changes in

manufacturing process like change in the time required forthe process like mixing, homogenization, recirculation

cooling time, and temperatures applied for various

processes.

7



Equipments:

Re validation must be done whenever there are changes in

equipment like instruments used for various measurementsin manufacturing and in process quality assurance, even

their repair and changes in the spare parts and components

must be considered for revalidation.

Support systems and maintenance: Revalidation must be done whenever there are changes and

repairing is done in the support systems ( water

system ventilation and air handling systems) and

production area these changes may be critical on product

quality, for example if the manufacturing aria is for sterile

products which may affect product quality, clean

room environment and sterility of the product in case

of sterile product manufactured by aseptic process.

8



A drug product may undergo changes over the time forimprovement in its formulation for efficacy and quality.

The equipment and the support systems may undergo wearand tear as well, therefore revalidation becomes importantrequirement hence adapting a intentionally.

Pre-planned scheduled revalidations, enables a firm to becapable of conducting revalidation efficiently andeffectively.

The frequency and period of revalidation can be decided bystudying data collected on regular basis from all in processquality control parameters and quality control reports of finished product.

9



Additionally, the following points should be checked at

the time of a scheduled revalidation:

Have any changes in master formula and methods, batch

size, etc., occurred? If so, has their impact on the product

been assessed?

Have calibrations been made in accordance with the

established programme and time schedule?

Has preventive maintenance been performed in

accordance with the programme and time schedule?

Have the standard operating procedures (SOPs) been

properly updated?

Have the SOPs been implemented?

Have the cleaning and hygiene programmes been carried

out?

Have any changes been made in the analytical control

methods? 10



http://whoguideline.blogspot.com/2011/06/

revalidation-aspects-revalidate-in.html

http://pharmaceuticalvalidation.blogspot.co

m/2008/01/types-of-process-validation.html

11

http://whoguideline.blogspot.com/2011/06/revalidation-aspects-revalidate-in.html


http://pharmaceuticalvalidation.blogspot.com/2008/01/types-of-process-validation.html




















Do you Have any queries

friends

12

re validation

Documents