Process Validation

What is Process Validation, Why we need it & Verification.

 Process Validation:
What is Process Validation, Why we need it
& Verification.

What will we learn?

 What is Process Validation

 Why do we need process validation?

 Difference between validation and verification

Process Validation: What is Process Validation, Why
we need it & Verification.
Why do we need it?  You are going for an operation in a
hospital.
 What about the Reusable Invasive
Medical Devices that will be used on you?
 Are they sterile?
 Are you sure?

 Special processes need to be validated.

 In this case the cleaning, disinfection and
sterilisation process of the RIMD.
 If you validate your process you are
guaranteeing that each RIMD will be
consistently sterile.
 Validation of all processes is a good idea.
 Validation is compulsory in some
industries.
Process Validation:
What is Process Validation, Why we need it &
Verification.
Why do you validate.
 To meet User Requirements Specification

 To establish scientific evidence that a process is capable of

consistently delivering quality product.

 Regulation dictates that it is used in the following industries.

 Medical Device
 Pharmaceutical Industry.
Process Validation
Why do you validate.

 Validation is required by law within the life science industry.

 If a company is a medical device company and it does not validate the process it
is deemed a criminal act.

 A medical device manufacturer who does not validate a process will not get
permission to manufacture or sell their product in the market place.

 Validation ensures quality assurance is built into a process.

 We cannot rely on quality control for validation. “Quality cannot be tested into a
product”

 If a customer knows that a process has been validated they have a good
assurance that each product will consistently meet user requirement
specification.

 Happy customer repeat business.

Verification
• Verification is a Quality Control process .

• It is used to evaluate whether or not a

product or service complies with
specifications.

• Verification is comparing conformity to

a defined specification.

• An example of verification in the

medical device industry would be
measuring the distance between
marker bands on a catheter.

• This can be done in the medical device

industry with a smart scope by using
point and click software.

• The software can confirm if the

measurement matches the
specification.

• If you cannot verify an output then you

must validate.
Process Validation: So when would you
NOT be able to verify?
 In the medical device industry bonding is utilised to join parts together.
 This can be done with adhesives or bonding heat.
 The only way one could verify the strength of the bond would be with a
destructive test.
 In this case then we must validate the process.
Validation
• Validation is a Quality Assurance process- it strives to establish
evidence that provides a high degree of assurance that a product,
service or system accomplishes its intended requirements
consistently.
Validation

• Common to use a 3 batch approach and use batches of normal production

size.

• Validation normally challenges the system/ process/equipment etc.

Regulation validation definitions

• FDA Quality System Regulation: ”Process Validation means

establishing by objective evidence that a process consistently
produces a result or product meeting its predetermined
specifications.”

• EU definition- “the act of proving in accordance with the principle

of GMP that any procedure, process, equipment, material, activity
or system leads to the expected results”
What have we learned
What have we learned
 Validation is required by law within the life science industry.
 Validation proves that a process consistently meets User Requirements
Specification.
 If a customer knows that a process has been validated they have a good
assurance that each product will consistently meet user requirement
specification.
 Happy customer repeat business.
 Validation is a Quality Assurance process.
 Verification is a Quality Control process .
 Verification is comparing conformity to a defined specification.
 If you can verify an output you don’t need to validate the process.